Bone Marrow Aspirate Concentration in Posterior Cervical Fusion (BMAC)
Primary Purpose
Cervical Myelopathy, Radiculopathy
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
locally harvested autograft, demineralized bone matrix, and cadaveric allograft
Bone Marrow Aspirate
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Myelopathy focused on measuring posterior cervical fusion, posterior cervical decompression
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Pregnant
- Active malignancy
- Previous history of posterior cervical decompression
Sites / Locations
- Washington University in St. Louis School of Medicine
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group 1 - Surigical Best Practice
Group 2 - autograft/BMAC
Arm Description
Group 1 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Neck Pain Affects Every Day Activities
Questionnaire that helps determine how a subject's neck pain affects their ability to manage every day activities.
Full Information
NCT ID
NCT02068547
First Posted
February 17, 2014
Last Updated
February 8, 2021
Sponsor
Washington University School of Medicine
Collaborators
Harvest Technologies
1. Study Identification
Unique Protocol Identification Number
NCT02068547
Brief Title
Bone Marrow Aspirate Concentration in Posterior Cervical Fusion
Acronym
BMAC
Official Title
Bone Marrow Aspirate Concentration in Posterior Cervical Fusion
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Sponsor closed study due to low enrollment
Sponsor closed study due to low enrollment
Sponsor closed study due to low enrollment.
Study Start Date
February 2014 (Actual)
Primary Completion Date
April 5, 2017 (Actual)
Study Completion Date
April 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Harvest Technologies
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Myelopathy, Radiculopathy
Keywords
posterior cervical fusion, posterior cervical decompression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 - Surigical Best Practice
Arm Type
Active Comparator
Arm Description
Group 1 will receive current best practice for posterior instrumented fusion (locally harvested autograft, demineralized bone matrix, and cadaveric allograft)
Arm Title
Group 2 - autograft/BMAC
Arm Type
Experimental
Arm Description
Group II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration.
Intervention Type
Biological
Intervention Name(s)
locally harvested autograft, demineralized bone matrix, and cadaveric allograft
Intervention Type
Biological
Intervention Name(s)
Bone Marrow Aspirate
Primary Outcome Measure Information:
Title
Rate of Fusion
Description
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.
Time Frame
6 months, 12 months, 24 months
Secondary Outcome Measure Information:
Title
Physical and Mental Health From Subject's Point of View
Description
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.
Time Frame
24 months
Title
Neck Pain Affects Every Day Activities
Description
Questionnaire that helps determine how a subject's neck pain affects their ability to manage every day activities.
Time Frame
24 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Pregnant
Active malignancy
Previous history of posterior cervical decompression
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilson Z Ray, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University in St. Louis School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bone Marrow Aspirate Concentration in Posterior Cervical Fusion
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