Bone Marrow Aspirate Concentration in Posterior Cervical Fusion

Radiculopathy Clinical Trial

— BMAC  

Official title:

Bone Marrow Aspirate Concentration in Posterior Cervical Fusion

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02068547
• Other study ID #: 201308043
• Status: Terminated
• Phase: N/A
• Start date: February 2014
• Est. completion date: April 5, 2017

Study information

• Verified date: February 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: April 5, 2017
• Est. primary completion date: April 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Myelopathy
• Radiculopathy
• Spinal Cord Diseases

Intervention

Biological:
• locally harvested autograft, demineralized bone matrix, and cadaveric allograft

• Bone Marrow Aspirate

Locations

Country	Name	City	State
United States	Washington University in St. Louis School of Medicine	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Harvest Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months, 12 months, 24 months
Secondary	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.	24 months
Secondary	Neck Pain Affects Every Day Activities	Questionnaire that helps determine how a subject's neck pain affects their ability to manage every day activities.	24 Months