Bone Marrow Aspirate Concentration in Posterior Cervical Fusion

Stopped early · Not applicable

Conditions studied: Cervical Myelopathy, Radiculopathy

In brief

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.

Key facts

Study ID

NCT02068547

Run by

Washington University School of Medicine

People needed

8

Starts

2014-02-01

Expected to finish

2017-04-05

Last updated by the study team

2021-03-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Washington University in St. Louis School of Medicine — St Louis, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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