Degenerative Disc DiseasePhase 4NCT03077204

BIO4 Clinical Case Study: Cervical Spine

A Phase 4 study testing 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window). and Aviator Anterior Cervical Plating System in people with Degenerative Disc Disease and Trauma (Including Fractures), run by Seton Healthcare Family at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this study is to investigate the efficacy of BIO4 bone matrix in patients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery. Specifically, the study aims to collect the data for ACDF model utilizing BIO4 with Bio AVS Cervical Allograft (with graft window). Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Degenerative Disc Disease, Trauma (Including Fractures), Spondylolisthesis
What is being tested?: 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window). and Aviator Anterior Cervical Plating System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 6 Apr 2017to 30 Jan 2020
Phase: Phase 4
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 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age>18 years
Scheduled 1 or 2-level ACDF spine surgery
The capacity to provide informed consent.
Subject has one or more of the following diagnoses:
Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Trauma (including fractures)

Show all 28Show fewer

Tumors
Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
Pseudoarthrosis
Failed previous fusion
Decompression of the spinal cord following total or partial cervical vertebrectomy
Spondylolisthesis
Spinal stenosis
Exclusion Criteria Patients with any of the following conditions will be excluded, or if enrolled and found to be ineligible and do not fit the inclusion criteria, will be withdrawn from the study.
Patients with current or recent history of malignancy or infectious disease.
The inability to provide informed consent.
Subject has marked local inflammation
Subject has any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care.
Subject has a bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the devices.
Subject has bone abnormalities preventing safe screw fixation.
Subject has any open wounds.
Subject has rapid joint disease, bone absorption, osteopenia, osteomalacia, and/or osteoporosis. Osteoporosis or osteopenia are relative contraindications, since this condition may limit the degree of obtainable correction and/or the amount of mechanical fixation.
Subject has a documented or suspected metal sensitivity.
Subject is pregnant.
Subject has anatomical structures or physiological performance that would interfere with implant utilization.
Subject has inadequate tissue coverage over the operative site.
Subject has other medical or surgical conditions which would preclude the potential benefit of surgery, such as congenital abnormalities, immunosuppressive disease, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or marked left shift in the WBC differential count.
Note: The Aviator Anterior Cervical Plating System is not approved or intended for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The surgeon must consider the levels of implantation, patient weight, patient activity level, and other patient conditions which may impact on the performance of the system.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Seton Spine and Scoliosis Center
Austin, Texas, 78731

Other trials in United States

About this study

Official title: Clinical and Radiographic Outcomes of BIO4 Bone Matrix in Patients Undergoing 1 or 2-Level Anterior Cervical Discectomy and Fusion Surgery

Read the detailed description

This is a prospective study with the intent to investigate the efficacy of BIO4 bone matrix in patients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery. At the time a patient is scheduled for surgery, the patient's chart will be evaluated for inclusion/exclusion criteria. If a patient meets the criteria for the study, the study will be explained to the patient and consent obtained.

Investigators will utilize the BIO4 on label as a 361 HCT/P (human cell, tissue and cellular and tissue-based product) for homologous use for the repair, replacement or reconstruction of bone defects. Interbody fusion (1 or 2-level fusion) in conjunction with an allograft (hct/p) interbody spacer (anterior approach in the cervical spine with hardware) will be utilized.

Investigators will also use the Aviator Anterior Cervical Plating System for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Aviator Anterior Cervical Plating System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Aviator plates are intended to be used with the Aviator bone screws.

Study Outcomes:

Radiological assessment (cervical spine x-ray and if needed, computed tomography (CT) at 1 year follow up)of fusion as the primary endpoint
Arthrodesis rates assessed using CT (1 year follow up, if needed) and Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays pre-operative (pre-op), post-operatively (post-op) 2~4 weeks (10~34 days post op), 3 months (83~97 days post-op), 6 months (173~187 days post-op) and 1 year post-op (351~379 days post op, primary data point outcome)
Revision rates
Outcome scores: Visual Analog Scale (VAS) and Neck Disability Index (NDI) pre-op, post-op 2~ 4weeks, 3 months, 6 months and 1 year.

The null hypothesis is that in ACDF model, the clinical and radiographic outcomes of utilizing BIO4 bone matrix with Bio AVS Cervical Allograft are equivalent to historical high level published data of similar product (Data reported in Meta-analysis ACDF obtained from FDA disc arthroplasty trials).

Conditions: Degenerative Disc Disease, Trauma (Including Fractures), Spondylolisthesis
Being tested: 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window)., Aviator Anterior Cervical Plating System
Keywords: Total cervical vertebrectomy, Partial cervical vertebrectomy, Failed previous fusion, Spinal stenosis, Tumor, Decompression of the spinal cord, Pseudoarthrosis, Curvatures, Deformities
Medical subject headings: Intervertebral Disc Degeneration, Wounds and Injuries, Spondylolisthesis, Spinal Stenosis, Neoplasms, Pseudarthrosis, Congenital Abnormalities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).Biological
The study will utilize the BIO4 on label as a 361 HCT/P (human cell, tissue and cellular and tissue-based product) for homologous use for the repair, replacement or reconstruction of bone defects. Interbody fusion (1 or 2-level fusion) in conjunction with an allograft (hct/p) interbody spacer (anterior approach in the cervical spine with hardware). Investigators will also use the Aviator Anterior Cervical Plating System for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Aviator Anterior Cervical Plating System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Aviator plates are intended to be used with the Aviator bone screws.
Aviator Anterior Cervical Plating SystemDevice
The study will utilize the BIO4 on label as a 361 HCT/P (human cell, tissue and cellular and tissue-based product) for homologous use for the repair, replacement or reconstruction of bone defects. Interbody fusion (1 or 2-level fusion) in conjunction with an allograft (hct/p) interbody spacer (anterior approach in the cervical spine with hardware). Investigators will also use the Aviator Anterior Cervical Plating System for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Aviator Anterior Cervical Plating System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Aviator plates are intended to be used with the Aviator bone screws.

Study groups in NCT03077204
Study group	Role	What they receive
BIO4 treatment	Other	Patients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery utilizing BIO4 with Bio AVS Cervical Allograft (with graft window). Receives: Biological: 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).; Device: Aviator Anterior Cervical Plating System

What is being measured

The primary outcome is the main question the study is designed to answer.

Radiological Assessment : Fusion Status
This will be used to monitor the fusion status at 1 year post-op. The fusion states was reported as the number of patients who fused. If fused, then we say "Yes". We counted the number of patients who fused. If all 20 patients fused then we said there were 20 "yes".
Measured: Post-op 1 year
Arthrodesis Rates
Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays will be used to access arthrodesis rates at different time intervals. We counted the number of patients who developed arthrodesis. The arthrodesis rate was calculated as the number of patients who developed arthrodesis.
Measured: Post-op 1 year

Secondary outcomes (18)

Revision Rates (if Any)
As needed, any post-operative surgical revision rates will be accessed. The revision rate was described as the number of patients who had to undergo revision post index surgery
Measured: Post-op 2~4 weeks
Revision Rates (if Any)
As needed, any post-operative surgical revision rates will be accessed. The revision rate was described as the number of patients who had to undergo revision post index surgery
Measured: Post-op 3 months
Revision Rates (if Any)
As needed, any post-operative surgical revision rates will be accessed. The revision rate was described as the number of patients who had to undergo revision post index surgery
Measured: Post-op 6 months
Revision Rates (if Any)
As needed, any post-operative surgical revision rates will be accessed. The revision rate was described as the number of patients who had to undergo revision post index surgery
Measured: Post-op 1 year
VAS
Patient reported VAS will be collected at different time intervals. The revision rate was described as the number of patients who had to undergo revision post index surgery. VAS: 0-10 (0=better, 10=worst)
Measured: Pre-op
VAS
Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)
Measured: Post-op 2 ~ 4 weeks
VAS
Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)
Measured: Post-op 3 months
VAS
Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)
Measured: Post-op 6 months
VAS
Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)
Measured: Post-op 1 year
NDI
Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst)
Measured: Pre-op
NDI
Patient reported NDI will be collected at different time intervals NDI: 0-100 (0=better, 100=worst)
Measured: Post-op 2~4 weeks
NDI
Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst)
Measured: Post-op 3 months
NDI
Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst)
Measured: Post-op 6 months
NDI
Patient reported NDI will be collected at different time intervals. NSI: 0-100 (0=better, 100=worst)
Measured: Post-op 1 year
Arthrodesis Rates
Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays will be used to access arthrodesis rates at different time intervals. The arthrodesis rate was calculated as the number of patients who developed arthrodesis.
Measured: Pre-op
Arthrodesis Rates
Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays will be used to access arthrodesis rates at different time intervals. The arthrodesis rate was calculated as the number of patients who developed arthrodesis.
Measured: Post-op 2~4 weeks
Arthrodesis Rates
Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays will be used to access arthrodesis rates at different time intervals. The arthrodesis rate was calculated as the number of patients who developed arthrodesis.
Measured: Post-op 3 months
Arthrodesis Rates
Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays will be used to access arthrodesis rates at different time intervals. The arthrodesis rate was calculated as the number of patients who developed arthrodesis.
Measured: Post-op 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Apr 201730 Jan 2020

First posted10 Mar 2017
Study start6 Apr 2017
Primary completion30 Jan 2020
Study completion30 Jan 2020

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.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03077204
Sponsor's protocol ID: CR-16-109
Status last verified: Dec 2021
First submitted: 27 Feb 2017
Last updated: 14 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Publications

Roberts TT, Rosenbaum AJ. Bone grafts, bone substitutes and orthobiologics: the bridge between basic science and clinical advancements in fracture healing. Organogenesis. 2012 Oct-Dec;8(4):114-24. doi: 10.4161/org.23306. Epub 2012 Oct 1.
PubMed 23247591
• Osiris Therapeutics-Data on File
• Bourke HE, Sandison A, Hughes SPF and Reichert ILH. Vascular Endothelial Growth Factor (VEGF) in Human Periosteum- Normal Expression and Response to Fracture, "Journal of Bone and Joint Surgery, British Volume (2003)
Epstein NE. An analysis of noninstrumented posterolateral lumbar fusions performed in predominantly geriatric patients using lamina autograft and beta tricalcium phosphate. Spine J. 2008 Nov-Dec;8(6):882-7. doi: 10.1016/j.spinee.2007.11.005. Epub 2008 Feb 14.
PubMed 18280215
Epstein NE. Beta tricalcium phosphate: observation of use in 100 posterolateral lumbar instrumented fusions. Spine J. 2009 Aug;9(8):630-8. doi: 10.1016/j.spinee.2009.04.007. Epub 2009 Jun 4.
PubMed 19501025
Eastlack RK, Garfin SR, Brown CR, Meyer SC. Osteocel Plus cellular allograft in anterior cervical discectomy and fusion: evaluation of clinical and radiographic outcomes from a prospective multicenter study. Spine (Phila Pa 1976). 2014 Oct 15;39(22):E1331-7. doi: 10.1097/BRS.0000000000000557.
PubMed 25188591

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Degenerative Disc Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical and Radiographic Outcomes of BIO4 Bone Matrix in Patients Undergoing 1 or 2-Level Anterior Cervical Discectomy and Fusion Surgery
ClinicalTrials.gov ID: NCT03077204
Acronym / sponsor ID: CR-16-109
Conditions: Degenerative Disc Disease, Trauma (Including Fractures), Spondylolisthesis
Keywords: Total cervical vertebrectomy, Partial cervical vertebrectomy, Failed previous fusion, Spinal stenosis, Tumor, Decompression of the spinal cord, Pseudoarthrosis, Curvatures
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Seton Healthcare FamilyUniversity, hospital or other
Study start: 6 Apr 2017 (actual)
Primary completion: 30 Jan 2020 (actual)
Study completion: 30 Jan 2020 (actual)
First posted: 10 Mar 2017 (actual)
Results: Posted 14 Jan 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study Outcomes:

Radiological assessment (cervical spine x-ray and if needed, computed tomography (CT) at 1 year follow up)of fusion as the primary endpoint
Arthrodesis rates assessed using CT (1 year follow up, if needed) and Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays pre-operative (pre-op), post-operatively (post-op) 2~4 weeks (10~34 days post op), 3 months (83~97 days post-op), 6 months (173~187 days post-op) and 1 year post-op (351~379 days post op, primary data point outcome)
Revision rates
Outcome scores: Visual Analog Scale (VAS) and Neck Disability Index (NDI) pre-op, post-op 2~ 4weeks, 3 months, 6 months and 1 year.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BIO4 treatment	Other	Biological: 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window)., Device: Aviator Anterior Cervical Plating SystemPatients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (28 listed)

Age>18 years
Scheduled 1 or 2-level ACDF spine surgery
The capacity to provide informed consent.
Subject has one or more of the following diagnoses:
Exclusion Criteria Patients with any of the following conditions will be excluded, or if enrolled and found to be ineligible and do not fit the inclusion criteria, will be withdrawn from the study.

Key exclusion criteria (0 listed)

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
1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).The study will utilize the BIO4 on label as a 361 HCT/P (human cell, tissue and cellular and tissue-based product) for homologous use for the repair, replacement or reconstruction of bone defects. Interbody fusion (1 or 2-level fusion) in conjunction with an allograft (hct/p) interbody spacer (anterior approach in the cervical spine with hardware). Investigators will also use the Aviator Anterior Cervical Plating System for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Aviator Anterior Cervical Plating System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Aviator plates are intended to be used with the Aviator bone screws.	Biological	BIO4 treatment
Aviator Anterior Cervical Plating SystemThe study will utilize the BIO4 on label as a 361 HCT/P (human cell, tissue and cellular and tissue-based product) for homologous use for the repair, replacement or reconstruction of bone defects. Interbody fusion (1 or 2-level fusion) in conjunction with an allograft (hct/p) interbody spacer (anterior approach in the cervical spine with hardware). Investigators will also use the Aviator Anterior Cervical Plating System for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Aviator Anterior Cervical Plating System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Aviator plates are intended to be used with the Aviator bone screws.	Device	BIO4 treatment

Primary outcome

Radiological Assessment : Fusion Status
Time frame: Post-op 1 year
This will be used to monitor the fusion status at 1 year post-op. The fusion states was reported as the number of patients who fused. If fused, then we say "Yes". We counted the number of patients who fused. If all 20 patients fused then we said there were 20 "yes".
Arthrodesis Rates
Time frame: Post-op 1 year
Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays will be used to access arthrodesis rates at different time intervals. We counted the number of patients who developed arthrodesis. The arthrodesis rate was calculated as the number of patients who developed arthrodesis.

18 secondary outcomes

Revision Rates (if Any)
Time frame: Post-op 2~4 weeks
Revision Rates (if Any)
Time frame: Post-op 3 months
Revision Rates (if Any)
Time frame: Post-op 6 months
Revision Rates (if Any)
Time frame: Post-op 1 year
VAS
Time frame: Pre-op
VAS
Time frame: Post-op 2 ~ 4 weeks
VAS
Time frame: Post-op 3 months
VAS
Time frame: Post-op 6 months
VAS
Time frame: Post-op 1 year
NDI
Time frame: Pre-op
NDI
Time frame: Post-op 2~4 weeks
NDI
Time frame: Post-op 3 months
NDI
Time frame: Post-op 6 months
NDI
Time frame: Post-op 1 year
Arthrodesis Rates
Time frame: Pre-op
Arthrodesis Rates
Time frame: Post-op 2~4 weeks
Arthrodesis Rates
Time frame: Post-op 3 months
Arthrodesis Rates
Time frame: Post-op 6 months

Results and safety

Results posted to the registry on 14 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BIO4 Treatment	20	20

Primary outcome: Radiological Assessment : Fusion Status

Time frame: Post-op 1 year. Number. Unit: participants

Measure	BIO4 Treatment n = 20
Value	20

Population analysed: Patients who underwent ACDF using BIO4

Primary outcome: Arthrodesis Rates

Time frame: Post-op 1 year. Number. Unit: participants

Measure	BIO4 Treatment n = 20
Value	0

Population analysed: Patients who underwent ACDF using BIO4

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BIO4 Treatment	1 of 20 (5%)	1 of 20 (5%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23247591Roberts TT, Rosenbaum AJ. Bone grafts, bone substitutes and orthobiologics: the bridge between basic science and clinical advancements in fracture healing. Organogenesis. 2012 Oct-Dec;8(4):114-24. doi: 10.4161/org.23306. Epub 2012 Oct 1.
Background• Osiris Therapeutics-Data on File
Background• Bourke HE, Sandison A, Hughes SPF and Reichert ILH. Vascular Endothelial Growth Factor (VEGF) in Human Periosteum- Normal Expression and Response to Fracture, "Journal of Bone and Joint Surgery, British Volume (2003)
Background: PubMed 18280215Epstein NE. An analysis of noninstrumented posterolateral lumbar fusions performed in predominantly geriatric patients using lamina autograft and beta tricalcium phosphate. Spine J. 2008 Nov-Dec;8(6):882-7. doi: 10.1016/j.spinee.2007.11.005. Epub 2008 Feb 14.
Background: PubMed 19501025Epstein NE. Beta tricalcium phosphate: observation of use in 100 posterolateral lumbar instrumented fusions. Spine J. 2009 Aug;9(8):630-8. doi: 10.1016/j.spinee.2009.04.007. Epub 2009 Jun 4.
Background: PubMed 25188591Eastlack RK, Garfin SR, Brown CR, Meyer SC. Osteocel Plus cellular allograft in anterior cervical discectomy and fusion: evaluation of clinical and radiographic outcomes from a prospective multicenter study. Spine (Phila Pa 1976). 2014 Oct 15;39(22):E1331-7. doi: 10.1097/BRS.0000000000000557.
Individual participant dataSharing planned: No

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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.

Eeric Truumees, MD principal investigator

Seton Spine and Scoliosis Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 28 inclusion and 0 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 14 Jan 2022. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2022). 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?

Radiological Assessment : Fusion Status (time frame: Post-op 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03077204, which also lists 6 linked publications.

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 14 Jan 2022.