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Bone Marrow Aspirate Concentration in Posterior Cervical Fusion (BMAC)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Harvest Technologies
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02068547
First received: February 17, 2014
Last updated: August 22, 2016
Last verified: December 2015
  Purpose

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.


Condition Intervention
Cervical Myelopathy
Radiculopathy
Biological: locally harvested autograft, demineralized bone matrix, and cadaveric allograft
Biological: Bone Marrow Aspirate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Bone Marrow Aspirate Concentration in Posterior Cervical Fusion

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Rate of Fusion [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    Questionnaire that helps determine how a subject's neck pain affects their ability to manage every day activities.


Estimated Enrollment: 100
Study Start Date: February 2014
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Surigical Best Practice
Group 1 will receive current best practice for posterior instrumented fusion (locally harvested autograft, demineralized bone matrix, and cadaveric allograft)
Biological: locally harvested autograft, demineralized bone matrix, and cadaveric allograft
Experimental: Group 2
Group II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration.
Biological: Bone Marrow Aspirate

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, ALS, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02068547

Locations
United States, Missouri
Washington University in St. Louis School of Medicine
St. Louis, Missouri, United States, 63110
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Harvest Technologies
Investigators
Principal Investigator: Wilson Z Ray, MD Washington University School of Medicine
  More Information

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02068547     History of Changes
Other Study ID Numbers: 201308043 
Study First Received: February 17, 2014
Last Updated: August 22, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
posterior cervical fusion
posterior cervical decompression

Additional relevant MeSH terms:
Radiculopathy
Spinal Cord Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on December 05, 2016