Bone Marrow Aspirate Concentration in Posterior Cervical Fusion

NCT ID: NCT02068547

Last Updated: 2021-03-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2017-04-05

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.

Conditions

Cervical Myelopathy; Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1 - Surigical Best Practice

Group 1 will receive current best practice for posterior instrumented fusion (locally harvested autograft, demineralized bone matrix, and cadaveric allograft)

Group Type: ACTIVE_COMPARATOR

locally harvested autograft, demineralized bone matrix, and cadaveric allograft

Intervention Type: BIOLOGICAL

Group 2 - autograft/BMAC

Group II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration.

Group Type: EXPERIMENTAL

Bone Marrow Aspirate

Intervention Type: BIOLOGICAL

Interventions

locally harvested autograft, demineralized bone matrix, and cadaveric allograft

Intervention Type: BIOLOGICAL

Bone Marrow Aspirate

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Harvest Technologies

INDUSTRY

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wilson Z Ray, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University in St. Louis School of Medicine

St Louis, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

201308043

Identifier Type: -

Identifier Source: org_study_id