Spinal FusionNCT02924571
BMAC & Allograft vs BMP-2
A study testing Bone Marrow Aspirate Concentrate (BMAC) + Allograft, Recombinant Human Bone Morphogenetic Protein-2 (BMP) and Autograft in people with Spinal Fusion, run by NYU Langone Health at 1 site in United States.
Trial summary
The aim of this investigation is to compare the use of bone marrow aspirate concentrate (BMAC) and allograft versus recombinant human bone morphogenetic protein-2 (BMP) versus the gold standard fusion in subjects undergoing elective lumbar spinal fusion with interbody support. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Fusion
- What is being tested?
- Bone Marrow Aspirate Concentrate (BMAC) + Allograft, Recombinant Human Bone Morphogenetic Protein-2 (BMP) and Autograft
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2018to 3 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be 18 years old or older
- Scheduled for elective posterior or anterior and posterior spinal fusion of the thoracolumbar spine with or without anterior interbody support
- Failed at least 6 weeks of conservative care
- No contraindication to BMAC (as per manufacturer)
- Signed consent form
Who cannot join
- Prior lumbar fusion surgery at operative level (prior discectomy and/or laminectomy allowed)
- Incompetent or missing anterior arch at the affected level (e.g. laminectomy, pars defect)
- Currently requires laminectomy at level of surgery
- Facet joints at implant level are absent or fractured
- Post-traumatic vertebral body compromise or acute fracture at implant level
- Body mass Index (BMI) > 40
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- Known allergy to titanium
- Paget's disease, osteomalacia, or any other metabolic bone disease
- Use of medications or any drug known to potentially interfere with bone/soft tissue healing (e.g. chronic systemic steroids)
- Unlikely to comply with the follow-up evaluation schedule
- Active malignancy defined as history of invasive malignancy, except if the subject has received treatment and displayed no clinical signs and symptoms for at least five years
- Pregnant or planning to become pregnant during the length of study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Prospective, Blinded, Non-randomized Study of Thoracolumbar Spinal Fusion Graft Efficacy: Bone Marrow Aspirate Concentrate and Allograft Versus Recombinant Bone Morphogenetic Protein-2 (BMP)
The aim of this investigation is to compare the use of bone marrow aspirate concentrate (BMAC) and allograft versus recombinant human bone morphogenetic protein-2 (BMP) versus the gold standard fusion in subjects undergoing elective lumbar spinal fusion with interbody support. The safety and efficacy of the surgical interventions will be evaluated by assessing fusion status and subjects' quality of life outcomes.
Read the detailed description
This study will be a prospective, randomized clinical study at a single-center, NYU Langone Medical Center. It is intended to compare and evaluate the efficacy of subjects who are either treated with (1) bone marrow aspirate concentrate (BMAC) and allograft or (2) recombinant human bone morphogenetic protein-2 (BMP) or (3) autograft (control) during lumbar spinal fusion with interbody support. The clinical, radiographic, and Health Related Quality of Life (HRQOL) outcomes will be assessed in operatively treated adult spinal degenerative disease patients undergoing lumbar spinal fusion.
- Conditions
- Spinal Fusion
- Being tested
- Bone Marrow Aspirate Concentrate (BMAC) + Allograft, Recombinant Human Bone Morphogenetic Protein-2 (BMP), Autograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow Aspirate Concentrate (BMAC) + AllograftDevice
Also called Harvest BMAC System
Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.
Recombinant Human Bone Morphogenetic Protein-2 (BMP)Device
Also called INFUSE rhBMP-2
INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.
AutograftProcedure or surgery
Autograft with bone marrow aspirate.
| Study group | Role | What they receive |
|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Experimental | A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite.
If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1):
* 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft)
* 2-level fusion: 20 cc of BMAC from 120 cc of BMA
* 3-level fusion: 20 cc of BMAC from 120 cc of BMA
* 4-level fusion: 180 cc kit
* 5-level fusion: 240 cc kit
If not using Harvest Graft Delivery Kit:
* Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). Receives: Device: Bone Marrow Aspirate Concentrate (BMAC) + Allograft |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | Active comparator | 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions.
The BMP kit use per level is as follows:
* 1 Level Fusion: Extra small kit (1.4 cc)
* 2 Level Fusion: Small Kit (2.8cc)
* 3 Level Fusion: (4.2 cc)
* 4 Level Fusion: Medium Kit (5.6cc)
* 5 Level Fusion: (7.0 cc) Receives: Device: Recombinant Human Bone Morphogenetic Protein-2 (BMP) |
| Autograft | Active comparator | As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Receives: Procedure: Autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Fusion Status at Month 12 Post-Procedure
Fusion status assessed via CT scan by an independent radiologist.
Measured: Month 12 Post-Operation
Oswestry Disability Index (ODI) Score at Pre-Op Visit
The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.
Measured: Pre-Operation Visit (Day 0)
ODI Score at Week 6 Follow-Up
The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.
Measured: Week 6 Post-Operation
ODI Score at Month 3 Follow-Up
The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.
Measured: Month 3 Post-Operation
ODI Score at Month 6 Follow-Up
The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.
Measured: Month 6 Post-Operation
ODI Score at Month 12 Follow-Up
The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.
Measured: Month 12 Post-Operation
ODI Score at Month 24 Follow-Up
The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.
Measured: Month 24 Post-Operation
Numeric Rating Scale (NRS) - Back Pain Score at Pre-Op Visit
Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.
Measured: Pre-Operation Visit (Day 0)
NRS - Back Pain Score at Week 6 Follow-Up
Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.
Measured: Week 6 Post-Operation
NRS - Back Pain Score at Month 3 Follow-Up
Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.
Measured: Month 3 Post-Operation
NRS - Back Pain Score at Month 6 Follow-Up
Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.
Measured: Month 6 Post-Operation
NRS - Back Pain Score at Month 12 Follow-Up
Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.
Measured: Month 12 Post-Operation
NRS - Back Pain Score at Month 24 Follow-Up
Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.
Measured: Month 24 Post-Operation
Short Form 12 (SF-12) - Physical Component Summary (PCS) Score at Pre-Op Visit
The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.
Measured: Pre-Operation Visit (Day 0)
SF-12 - PCS Score at Week 6 Follow-Up
The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.
Measured: Week 6 Post-Operation
SF-12 - PCS Score at Month 3 Follow-Up
The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.
Measured: Month 3 Post-Operation
SF-12 - PCS Score at Month 6 Follow-Up
The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.
Measured: Month 6 Post-Operation
SF-12 - PCS Score at Month 12 Follow-Up
The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.
Measured: Month 12 Post-Operation
SF-12 - PCS Score at Month 24 Follow-Up
The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.
Measured: Month 24 Post-Operation
SF-12 - Mental Component Summary (MCS) Score at Pre-Op Visit
The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.
Measured: Pre-Operation Visit (Day 0)
SF-12 - MCS Score at Week 6 Follow-Up
The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.
Measured: Week 6 Post-Operation
SF-12 - MCS Score at Month 3 Follow-Up
The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.
Measured: Month 3 Follow-Up Post-Operation
SF-12 - MCS Score at Month 6 Follow-Up
The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.
Measured: Month 6 Post-Operation
Euro-Qol 5-Dimension (EQ-5D) Score at Pre-Op Visit
5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health.
Measured: Pre-Operation Visit (Day 0)
EQ-5D Score at Week 6 Follow-Up
5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health.
Measured: Week 6 Post-Operation
EQ-5D Score at Month 3 Follow-Up
5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health.
Measured: Month 3 Post-Operation
EQ-5D Score at Month 6 Follow-Up
5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health.
Measured: Month 6 Post-Operation
EQ-5D Score at Month 12 Follow-Up
5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health.
Measured: Month 12 Post-Operation
EQ-5D Score at Month 24 Follow-Up
5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health.
Measured: Month 24 Post-Operation
Pain Catastrophizing Scale (PCS) Score at Pre-Op Visit
Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain.
Measured: Pre-Operation Visit (Day 0)
PCS Score at Week 6 Follow-Up
Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain.
Measured: Week 6 Post-Operation
PCS Score at Month 3 Follow-Up
Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain.
Measured: Month 3 Post-Operation
PCS Score at Month 6 Follow-Up
Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain.
Measured: Month 6 Post-Operation
PCS Score at Month 12 Follow-Up
Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain.
Measured: Month 12 Post-Operation
PCS Score at Month 24 Follow-Up
Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain.
Measured: Month 24 Post-Operation
Patient Reported Outcome Measure Information System (PROMIS) Item Bank v1.1 - Pain Interference Score at Pre-Op Visit
40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.
Measured: Pre-Operation Visit (Day 0)
PROMIS Item Bank v1.1 - Pain Interference Score at Week 6 Follow-Up
40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.
Measured: Week 6 Post-Operation
PROMIS Item Bank v1.1 - Pain Interference Score at Month 3 Follow-Up
40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.
Measured: Month 3 Post-Operation
PROMIS Item Bank v1.1 - Pain Interference Score at Month 6 Follow-Up
40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.
Measured: Month 6 Post-Operation
PROMIS Item Bank v1.1 - Pain Interference Score at Month 12 Follow-Up
40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.
Measured: Month 12 Post-Operation
PROMIS Item Bank v1.1 - Pain Interference Score at Month 24 Follow-Up
40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.
Measured: Month 24 Post-Operation
PROMIS Scale v1.0 - Pain Intensity 3a Score at Pre-Op Visit
3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.
Measured: Pre-Operation Visit (Day 0)
PROMIS Scale v1.0 - Pain Intensity 3a Score at Week 6 Follow-Up
3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.
Measured: Week 6 Post-Operation
PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 3 Follow-Up
3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.
Measured: Month 3 Post-Operation
PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 6 Follow-Up
3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.
Measured: Month 6 Post-Operation
PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 12 Follow-Up
3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.
Measured: Month 12 Post-Operation
PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 24 Follow-Up
3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.
Measured: Month 24 Post-Operation
PROMIS Bank v1.2 - Physical Function Score at Pre-Op Visit
120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.
Measured: Pre-Operation Visit (Day 0)
PROMIS Bank v1.2 - Physical Function Score at Week 6 Follow-Up
120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.
Measured: Week 6 Post-Operation
PROMIS Bank v1.2 - Physical Function Score at Month 3 Follow-Up
120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.
Measured: Month 3 Post-Operation
PROMIS Bank v1.2 - Physical Function Score at Month 6 Follow-Up
120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.
Measured: Month 6 Post-Operation
PROMIS Bank v1.2 - Physical Function Score at Month 12 Follow-Up
120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.
Measured: Month 12 Post-Operation
PROMIS Bank v1.2 - Physical Function Score at Month 24 Follow-Up
120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.
Measured: Month 24 Post-Operation
PROMIS Bank v2.0 - Mobility Score at Pre-Op Visit
15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.
Measured: Pre-Operation Visit (Day 0)
PROMIS Bank v2.0 - Mobility Score at Week 6 Follow-Up
15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.
Measured: Week 6 Post-Operation
PROMIS Bank v2.0 - Mobility Score at Month 3 Follow-Up
15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.
Measured: Month 3 Post-Operation
PROMIS Bank v2.0 - Mobility Score at Month 6 Follow-Up
15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.
Measured: Month 6 Post-Operation
PROMIS Bank v2.0 - Mobility Score at Month 12 Follow-Up
15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.
Measured: Month 12 Post-Operation
PROMIS Bank v2.0 - Mobility Score at Month 24 Follow-Up
15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.
Measured: Month 24 Post-Operation
Length of Operation
Measured: Intraoperative Period (Day 0) (typically between 2-7 hours)
Length of Hospital Stay
Measured: From admission up to discharge (Up to Year 2 Post-Operation)
Blood Loss During Procedure
Measured: Intraoperative Period (Day 0) (typically between 2-7 hours)
Number of Participants Using Non-Prescription, Over-the-Counter (OTC) Drugs at Pre-Op Visit
Number of participants taking OTC drugs for pain relief.
Measured: Pre-Operation Visit (Day 0)
Number of Participants Using Non-Prescription, OTC Drugs at Week 6 Follow-Up
Number of participants taking OTC drugs for pain relief.
Measured: Week 6 Post-Operation
Number of Participants Using Non-Prescription, OTC Drugs at Month 3 Follow-Up
Number of participants taking OTC drugs for pain relief.
Measured: Month 3 Post-Operation
Number of Participants Using Non-Prescription, OTC Drugs at Month 6 Follow-Up
Number of participants taking OTC drugs for pain relief.
Measured: Month 6 Post-Operation
Number of Participants Using Non-Prescription, OTC Drugs at Month 12 Follow-Up
Number of participants taking OTC drugs for pain relief.
Measured: Month 12 Post-Operation
Number of Participants Using Non-Prescription, OTC Drugs at Month 24 Follow-Up
Number of participants taking OTC drugs for pain relief.
Measured: Month 24 Post-Operation
Number of Participants With Surgical Complications During Operation
Measured: Intraoperative Period (Day 0) (typically between 2-7 hours)
Number of Participants With Surgical Complications at Week 6 Follow-Up
Measured: Week 6 Post-Operation
Number of Participants With Surgical Complications at Month 3 Follow-Up
Measured: Month 3 Post-Operation
Number of Participants With Surgical Complications at Month 6 Follow-Up
Measured: Month 6 Post-Operation
Number of Participants With Surgical Complications at Month 12 Follow-Up
Measured: Month 12 Post-Operation
Number of Participants With Surgical Complications at Month 24 Follow-Up
Measured: Month 24 Post-Operation
SF-12 - MCS Score at Month 12 Follow-Up
The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.
Measured: Month 12 Post-Operation
SF-12 - MCS Score at Month 24 Follow-Up
The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.
Measured: Month 12 Post-Operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start24 Jul 2018
- Primary completion3 Jun 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal FusionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Passias, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924571
- Sponsor's protocol ID
- 16-01160
- Status last verified
- Jun 2025
- First submitted
- 3 Oct 2016
- Last updated
- 8 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Blinded, Non-randomized Study of Thoracolumbar Spinal Fusion Graft Efficacy: Bone Marrow Aspirate Concentrate and Allograft Versus Recombinant Bone Morphogenetic Protein-2 (BMP)
- ClinicalTrials.gov ID
- NCT02924571
- Acronym / sponsor ID
- 16-01160
- Conditions
- Spinal Fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 24 Jul 2018 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Posted 8 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this investigation is to compare the use of bone marrow aspirate concentrate (BMAC) and allograft versus recombinant human bone morphogenetic protein-2 (BMP) versus the gold standard fusion in subjects undergoing elective lumbar spinal fusion with interbody support. The safety and efficacy of the surgical interventions will be evaluated by assessing fusion status and subjects' quality of life outcomes.
Detailed description
This study will be a prospective, randomized clinical study at a single-center, NYU Langone Medical Center. It is intended to compare and evaluate the efficacy of subjects who are either treated with (1) bone marrow aspirate concentrate (BMAC) and allograft or (2) recombinant human bone morphogenetic protein-2 (BMP) or (3) autograft (control) during lumbar spinal fusion with interbody support. The clinical, radiographic, and Health Related Quality of Life (HRQOL) outcomes will be assessed in operatively treated adult spinal degenerative disease patients undergoing lumbar spinal fusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Experimental | Device: Bone Marrow Aspirate Concentrate (BMAC) + AllograftA total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): * 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft) * 2-level fusion: 20 cc of BMAC from 120 cc of BMA * 3-level fusion: 20 cc of BMAC from 120 cc of BMA * 4-level fusion: 180 cc kit * 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: * Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls). |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | Active comparator | Device: Recombinant Human Bone Morphogenetic Protein-2 (BMP)12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: * 1 Level Fusion: Extra small kit (1.4 cc) * 2 Level Fusion: Small Kit (2.8cc) * 3 Level Fusion: (4.2 cc) * 4 Level Fusion: Medium Kit (5.6cc) * 5 Level Fusion: (7.0 cc) |
| Autograft | Active comparator | Procedure: AutograftAs per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be 18 years old or older
- Scheduled for elective posterior or anterior and posterior spinal fusion of the thoracolumbar spine with or without anterior interbody support
- Failed at least 6 weeks of conservative care
- No contraindication to BMAC (as per manufacturer)
- Signed consent form
Key exclusion criteria (12 listed)
- Prior lumbar fusion surgery at operative level (prior discectomy and/or laminectomy allowed)
- Incompetent or missing anterior arch at the affected level (e.g. laminectomy, pars defect)
- Currently requires laminectomy at level of surgery
- Facet joints at implant level are absent or fractured
- Post-traumatic vertebral body compromise or acute fracture at implant level
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + AllograftAlso: Harvest BMAC SystemAllograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site. | Device | Bone Marrow Aspirate Concentrate (BMAC) + Allograft |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP)Also: INFUSE rhBMP-2INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages. | Device | Recombinant Human Bone Morphogenetic Protein-2 (BMP) |
| AutograftAutograft with bone marrow aspirate. | Procedure or surgery | Autograft |
Primary outcome
Number of Participants With Successful Fusion Status at Month 12 Post-Procedure
Time frame: Month 12 Post-Operation
Fusion status assessed via CT scan by an independent radiologist.
Oswestry Disability Index (ODI) Score at Pre-Op Visit
Time frame: Pre-Operation Visit (Day 0)
The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.
ODI Score at Week 6 Follow-Up
Time frame: Week 6 Post-Operation
The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.
ODI Score at Month 3 Follow-Up
Time frame: Month 3 Post-Operation
The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.
ODI Score at Month 6 Follow-Up
Time frame: Month 6 Post-Operation
The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.
ODI Score at Month 12 Follow-Up
Time frame: Month 12 Post-Operation
The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.
ODI Score at Month 24 Follow-Up
Time frame: Month 24 Post-Operation
The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.
Numeric Rating Scale (NRS) - Back Pain Score at Pre-Op Visit
Time frame: Pre-Operation Visit (Day 0)
Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.
NRS - Back Pain Score at Week 6 Follow-Up
Time frame: Week 6 Post-Operation
Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.
NRS - Back Pain Score at Month 3 Follow-Up
Time frame: Month 3 Post-Operation
Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.
NRS - Back Pain Score at Month 6 Follow-Up
Time frame: Month 6 Post-Operation
Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.
NRS - Back Pain Score at Month 12 Follow-Up
Time frame: Month 12 Post-Operation
Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.
NRS - Back Pain Score at Month 24 Follow-Up
Time frame: Month 24 Post-Operation
Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.
Short Form 12 (SF-12) - Physical Component Summary (PCS) Score at Pre-Op Visit
Time frame: Pre-Operation Visit (Day 0)
The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.
SF-12 - PCS Score at Week 6 Follow-Up
Time frame: Week 6 Post-Operation
The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.
SF-12 - PCS Score at Month 3 Follow-Up
Time frame: Month 3 Post-Operation
The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.
SF-12 - PCS Score at Month 6 Follow-Up
Time frame: Month 6 Post-Operation
The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.
SF-12 - PCS Score at Month 12 Follow-Up
Time frame: Month 12 Post-Operation
The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.
SF-12 - PCS Score at Month 24 Follow-Up
Time frame: Month 24 Post-Operation
The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.
SF-12 - Mental Component Summary (MCS) Score at Pre-Op Visit
Time frame: Pre-Operation Visit (Day 0)
The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.
SF-12 - MCS Score at Week 6 Follow-Up
Time frame: Week 6 Post-Operation
The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.
SF-12 - MCS Score at Month 3 Follow-Up
Time frame: Month 3 Follow-Up Post-Operation
The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.
SF-12 - MCS Score at Month 6 Follow-Up
Time frame: Month 6 Post-Operation
The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.
Euro-Qol 5-Dimension (EQ-5D) Score at Pre-Op Visit
Time frame: Pre-Operation Visit (Day 0)
5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health.
EQ-5D Score at Week 6 Follow-Up
Time frame: Week 6 Post-Operation
5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health.
EQ-5D Score at Month 3 Follow-Up
Time frame: Month 3 Post-Operation
5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health.
EQ-5D Score at Month 6 Follow-Up
Time frame: Month 6 Post-Operation
5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health.
EQ-5D Score at Month 12 Follow-Up
Time frame: Month 12 Post-Operation
5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health.
EQ-5D Score at Month 24 Follow-Up
Time frame: Month 24 Post-Operation
5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health.
Pain Catastrophizing Scale (PCS) Score at Pre-Op Visit
Time frame: Pre-Operation Visit (Day 0)
Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain.
PCS Score at Week 6 Follow-Up
Time frame: Week 6 Post-Operation
Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain.
PCS Score at Month 3 Follow-Up
Time frame: Month 3 Post-Operation
Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain.
PCS Score at Month 6 Follow-Up
Time frame: Month 6 Post-Operation
Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain.
PCS Score at Month 12 Follow-Up
Time frame: Month 12 Post-Operation
Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain.
PCS Score at Month 24 Follow-Up
Time frame: Month 24 Post-Operation
Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain.
Patient Reported Outcome Measure Information System (PROMIS) Item Bank v1.1 - Pain Interference Score at Pre-Op Visit
Time frame: Pre-Operation Visit (Day 0)
40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.
PROMIS Item Bank v1.1 - Pain Interference Score at Week 6 Follow-Up
Time frame: Week 6 Post-Operation
40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.
PROMIS Item Bank v1.1 - Pain Interference Score at Month 3 Follow-Up
Time frame: Month 3 Post-Operation
40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.
PROMIS Item Bank v1.1 - Pain Interference Score at Month 6 Follow-Up
Time frame: Month 6 Post-Operation
40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.
PROMIS Item Bank v1.1 - Pain Interference Score at Month 12 Follow-Up
Time frame: Month 12 Post-Operation
40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.
PROMIS Item Bank v1.1 - Pain Interference Score at Month 24 Follow-Up
Time frame: Month 24 Post-Operation
40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.
PROMIS Scale v1.0 - Pain Intensity 3a Score at Pre-Op Visit
Time frame: Pre-Operation Visit (Day 0)
3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.
PROMIS Scale v1.0 - Pain Intensity 3a Score at Week 6 Follow-Up
Time frame: Week 6 Post-Operation
3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.
PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 3 Follow-Up
Time frame: Month 3 Post-Operation
3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.
PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 6 Follow-Up
Time frame: Month 6 Post-Operation
3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.
PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 12 Follow-Up
Time frame: Month 12 Post-Operation
3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.
PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 24 Follow-Up
Time frame: Month 24 Post-Operation
3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.
PROMIS Bank v1.2 - Physical Function Score at Pre-Op Visit
Time frame: Pre-Operation Visit (Day 0)
120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.
PROMIS Bank v1.2 - Physical Function Score at Week 6 Follow-Up
Time frame: Week 6 Post-Operation
120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.
PROMIS Bank v1.2 - Physical Function Score at Month 3 Follow-Up
Time frame: Month 3 Post-Operation
120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.
PROMIS Bank v1.2 - Physical Function Score at Month 6 Follow-Up
Time frame: Month 6 Post-Operation
120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.
PROMIS Bank v1.2 - Physical Function Score at Month 12 Follow-Up
Time frame: Month 12 Post-Operation
120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.
PROMIS Bank v1.2 - Physical Function Score at Month 24 Follow-Up
Time frame: Month 24 Post-Operation
120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.
PROMIS Bank v2.0 - Mobility Score at Pre-Op Visit
Time frame: Pre-Operation Visit (Day 0)
15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.
PROMIS Bank v2.0 - Mobility Score at Week 6 Follow-Up
Time frame: Week 6 Post-Operation
15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.
PROMIS Bank v2.0 - Mobility Score at Month 3 Follow-Up
Time frame: Month 3 Post-Operation
15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.
PROMIS Bank v2.0 - Mobility Score at Month 6 Follow-Up
Time frame: Month 6 Post-Operation
15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.
PROMIS Bank v2.0 - Mobility Score at Month 12 Follow-Up
Time frame: Month 12 Post-Operation
15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.
PROMIS Bank v2.0 - Mobility Score at Month 24 Follow-Up
Time frame: Month 24 Post-Operation
15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.
Length of Operation
Time frame: Intraoperative Period (Day 0) (typically between 2-7 hours)
Length of Hospital Stay
Time frame: From admission up to discharge (Up to Year 2 Post-Operation)
Blood Loss During Procedure
Time frame: Intraoperative Period (Day 0) (typically between 2-7 hours)
Number of Participants Using Non-Prescription, Over-the-Counter (OTC) Drugs at Pre-Op Visit
Time frame: Pre-Operation Visit (Day 0)
Number of participants taking OTC drugs for pain relief.
Number of Participants Using Non-Prescription, OTC Drugs at Week 6 Follow-Up
Time frame: Week 6 Post-Operation
Number of participants taking OTC drugs for pain relief.
Number of Participants Using Non-Prescription, OTC Drugs at Month 3 Follow-Up
Time frame: Month 3 Post-Operation
Number of participants taking OTC drugs for pain relief.
Number of Participants Using Non-Prescription, OTC Drugs at Month 6 Follow-Up
Time frame: Month 6 Post-Operation
Number of participants taking OTC drugs for pain relief.
Number of Participants Using Non-Prescription, OTC Drugs at Month 12 Follow-Up
Time frame: Month 12 Post-Operation
Number of participants taking OTC drugs for pain relief.
Number of Participants Using Non-Prescription, OTC Drugs at Month 24 Follow-Up
Time frame: Month 24 Post-Operation
Number of participants taking OTC drugs for pain relief.
Number of Participants With Surgical Complications During Operation
Time frame: Intraoperative Period (Day 0) (typically between 2-7 hours)
Number of Participants With Surgical Complications at Week 6 Follow-Up
Time frame: Week 6 Post-Operation
Number of Participants With Surgical Complications at Month 3 Follow-Up
Time frame: Month 3 Post-Operation
Number of Participants With Surgical Complications at Month 6 Follow-Up
Time frame: Month 6 Post-Operation
Number of Participants With Surgical Complications at Month 12 Follow-Up
Time frame: Month 12 Post-Operation
Number of Participants With Surgical Complications at Month 24 Follow-Up
Time frame: Month 24 Post-Operation
SF-12 - MCS Score at Month 12 Follow-Up
Time frame: Month 12 Post-Operation
The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.
SF-12 - MCS Score at Month 24 Follow-Up
Time frame: Month 12 Post-Operation
The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Passias principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone Marrow Aspirate Concentrate (BMAC) + Allograft, Recombinant Human Bone Morphogenetic Protein-2 (BMP) and Autograft in people with Spinal Fusion, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Successful Fusion Status at Month 12 Post-Procedure (time frame: Month 12 Post-Operation). The study lists 76 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.