Cervical MyelopathyBMACNCT02068547
Bone Marrow Aspirate Concentration in Posterior Cervical Fusion
A study testing locally harvested autograft, demineralized bone matrix, and cadaveric allograft and Bone Marrow Aspirate in people with Cervical Myelopathy and Radiculopathy, run by Washington University School of Medicine at 2 sites in United States.
Trial summary
The purpose of this research is to test if that combining bone marrow aspirate (removing bone marrow with a needle) concentration with locally harvested (collected) autograft (patient's own bone from another part of the body) for use as the bone graft results in equal rates of a successful procedure (fusion), as… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cervical Myelopathy, Radiculopathy
- What is being tested?
- locally harvested autograft, demineralized bone matrix, and cadaveric allograft and Bone Marrow Aspirate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2014to 5 Apr 2017
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75
- Have at least one of the following high risk qualifications: BMI >30, Rheumatoid Arthritis, Osteoporosis, Current smoker
- Able to cooperate in the completion of standardized outcome measures (multiple questionnaires)
- Willing and able to comply with study protocol
- Symptomatic cervical myelopathy and/or radiculopathy
- Scheduled for cervical alignment, allowing management with a posterior approach
Who cannot join
- MRI incompatible device
- History of prior cervical instrumentation
- Requires an instrumented anterior cervical fusion
- History of underlying neurological condition affecting the cervical spine (MS, Amyotrophic Lateral Sclerosis, HIV)
- Pre-existent neurologic disorder or mental disorder that would preclude accurate evaluation (psychiatric disease, Parkinson's disease, Alzheimer's disease)
- History of previous cervical fusion at the operative site
Show all 9Show fewer
- Pregnant
- Active malignancy
- Previous history of posterior cervical decompression
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Washington University in St. Louis School of Medicine
St Louis, Missouri, 63110
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
The purpose of this research is to test if that combining bone marrow aspirate (removing bone marrow with a needle) concentration with locally harvested (collected) autograft (patient's own bone from another part of the body) for use as the bone graft results in equal rates of a successful procedure (fusion), as compared to current best practice in high-risk patients undergoing posterior cervical fusion.
Hypothesis: Bone marrow aspirate concentration combined with locally harvested autograft results in equivalent rates of bony fusion, as compared to current best practice in high-risk patients undergoing posterior cervical decompression and fusion.
Read the detailed description
100 consecutive high-risk patients who meet the following inclusion criteria: are 18-75 years of age, require a cervical spine MRI as part of their standard of care show evidence of CSM, and have cervical alignment allowing posterior instrumented fusion. High-risk will be defined as having a diagnosis of rheumatoid arthritis, osteoporosis, current smoker, or BMI >30. Patients will be excluded if they have any MRI incompatible devices, have any prior cervical instrumentation, require an instrumented anterior cervical fusion, or have an underlying neurological condition affecting the cervical spine (MS, ALS, HIV).
Patients will be sequentially randomized to one of two treatment groups. Group I, will receive current best practice for posterior instrumented fusion (locally harvested autograft, demineralized bone matrix, and cadaveric allograft). Group II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration. To assist with analysis, we will collect information from patients' hematology results, obtained per their standard of care pre-operative workup. All patients will be treated post-operatively at the discretion of the treating surgeon. All patients will follow-up at 6 weeks, 3 months, 6 months, 12 months, and 24 months. At the 6, 12, and 24-month follow-up all patients will undergo flexion/extension X-rays, fusion will be defined as less than 2 mm or motion. A cervical spine CT may also be obtained at 24 months on all patients to assess fusion at the discretion of the treating surgeon. All radiographic assessments of fusion will be made by a Washington University staff radiologist, blinded to patient treatment.
- Conditions
- Cervical Myelopathy, Radiculopathy
- Being tested
- locally harvested autograft, demineralized bone matrix, and cadaveric allograft, Bone Marrow Aspirate
- Keywords
- posterior cervical fusion, posterior cervical decompression
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
locally harvested autograft, demineralized bone matrix, and cadaveric allograftBiological
Bone Marrow AspirateBiological
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Surigical Best Practice | Active comparator | Group 1 will receive current best practice for posterior instrumented fusion (locally harvested autograft, demineralized bone matrix, and cadaveric allograft) Receives: Biological: locally harvested autograft, demineralized bone matrix, and cadaveric allograft |
| Group 2 - autograft/BMAC | Experimental | Group II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration. Receives: Biological: Bone Marrow Aspirate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Fusion
Rate of fusion - (6, 12, and 24 months) Rate of fusion will be assessed by flexion extension X-rays at routine follow-up, translation method (<2mm) and/or by computed tomography (CT) scan at 2 year post-operatively.
Measured: 6 months, 12 months, 24 months
Secondary outcomes (2)
Physical and Mental Health From Subject's Point of View
Short Form 36 (SF-36) is a profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.
Measured: 24 months
Neck Pain Affects Every Day Activities
Questionnaire that helps determine how a subject's neck pain affects their ability to manage every day activities.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completion5 Apr 2017
- Study completion5 Apr 2017
Why it stopped: Sponsor closed study due to low enrollment Sponsor closed study due to low enrollment Sponsor closed study due to low enrollment.
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 Cervical MyelopathyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Harvest Technologies
- Responsible party
- Sponsor
- Investigators
- Wilson Z Ray, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068547
- Sponsor's protocol ID
- 201308043
- Acronym
- BMAC
- Status last verified
- Feb 2021
- First submitted
- 17 Feb 2014
- Last updated
- 2 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Aspirate Concentration in Posterior Cervical Fusion
- ClinicalTrials.gov ID
- NCT02068547
- Acronym / sponsor ID
- BMAC / 201308043
- Conditions
- Cervical Myelopathy, Radiculopathy
- Keywords
- posterior cervical fusion, posterior cervical decompression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor closed study due to low enrollment Sponsor closed study due to low enrollment Sponsor closed study due to low enrollment.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Harvest Technologies
- Study start
- Feb 2014 (actual)
- Primary completion
- 5 Apr 2017 (actual)
- Study completion
- 5 Apr 2017 (actual)
- First posted
- 21 Feb 2014 (estimated)
- Results
- Posted 18 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to test if that combining bone marrow aspirate (removing bone marrow with a needle) concentration with locally harvested (collected) autograft (patient's own bone from another part of the body) for use as the bone graft results in equal rates of a successful procedure (fusion), as compared to current best practice in high-risk patients undergoing posterior cervical fusion.
Hypothesis: Bone marrow aspirate concentration combined with locally harvested autograft results in equivalent rates of bony fusion, as compared to current best practice in high-risk patients undergoing posterior cervical decompression and fusion.
Detailed description
100 consecutive high-risk patients who meet the following inclusion criteria: are 18-75 years of age, require a cervical spine MRI as part of their standard of care show evidence of CSM, and have cervical alignment allowing posterior instrumented fusion. High-risk will be defined as having a diagnosis of rheumatoid arthritis, osteoporosis, current smoker, or BMI >30. Patients will be excluded if they have any MRI incompatible devices, have any prior cervical instrumentation, require an instrumented anterior cervical fusion, or have an underlying neurological condition affecting the cervical spine (MS, ALS, HIV).
Patients will be sequentially randomized to one of two treatment groups. Group I, will receive current best practice for posterior instrumented fusion (locally harvested autograft, demineralized bone matrix, and cadaveric allograft). Group II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration. To assist with analysis, we will collect information from patients' hematology results, obtained per their standard of care pre-operative workup. All patients will be treated post-operatively at the discretion of the treating surgeon. All patients will follow-up at 6 weeks, 3 months, 6 months, 12 months, and 24 months. At the 6, 12, and 24-month follow-up all patients will undergo flexion/extension X-rays, fusion will be defined as less than 2 mm or motion. A cervical spine CT may also be obtained at 24 months on all patients to assess fusion at the discretion of the treating surgeon. All radiographic assessments of fusion will be made by a Washington University staff radiologist, blinded to patient treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Surigical Best Practice | Active comparator | Biological: locally harvested autograft, demineralized bone matrix, and cadaveric allograftGroup 1 will receive current best practice for posterior instrumented fusion (locally harvested autograft, demineralized bone matrix, and cadaveric allograft) |
| Group 2 - autograft/BMAC | Experimental | Biological: Bone Marrow AspirateGroup II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 75
- Have at least one of the following high risk qualifications: BMI >30, Rheumatoid Arthritis, Osteoporosis, Current smoker
- Able to cooperate in the completion of standardized outcome measures (multiple questionnaires)
- Willing and able to comply with study protocol
- Symptomatic cervical myelopathy and/or radiculopathy
Key exclusion criteria (9 listed)
- MRI incompatible device
- History of prior cervical instrumentation
- Requires an instrumented anterior cervical fusion
- History of underlying neurological condition affecting the cervical spine (MS, Amyotrophic Lateral Sclerosis, HIV)
- Pre-existent neurologic disorder or mental disorder that would preclude accurate evaluation (psychiatric disease, Parkinson's disease, Alzheimer's disease)
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 |
|---|---|---|
| locally harvested autograft, demineralized bone matrix, and cadaveric allograft | Biological | Group 1 - Surigical Best Practice |
| Bone Marrow Aspirate | Biological | Group 2 - autograft/BMAC |
Primary outcome
Rate of Fusion
Time frame: 6 months, 12 months, 24 months
Rate of fusion - (6, 12, and 24 months) Rate of fusion will be assessed by flexion extension X-rays at routine follow-up, translation method (<2mm) and/or by computed tomography (CT) scan at 2 year post-operatively.
2 secondary outcomes
Physical and Mental Health From Subject's Point of View
Time frame: 24 months
Neck Pain Affects Every Day Activities
Time frame: 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- 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.
Wilson Z Ray, MD principal investigator
Washington University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing locally harvested autograft, demineralized bone matrix, and cadaveric allograft and Bone Marrow Aspirate in people with Cervical Myelopathy and Radiculopathy, run by Washington University School of Medicine at 2 sites 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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 18 May 2018). 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?
Rate of Fusion (time frame: 6 months, 12 months, 24 months). 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 2 Mar 2021.