Actifuse SHAPE vs Autograft for Spinal Cord Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two types of bone grafts used in neck surgery for patients with severe spinal conditions. One uses a synthetic material combined with the patient's bone marrow, while the other uses the patient's own bone mixed with processed bone material. These grafts help new bone grow and stabilize the spine, reducing pain and improving function.
Who Is on the Research Team?
Hazem Eltahawy, MD
Principal Investigator
Wayne State University, DMC
Are You a Good Fit for This Trial?
This trial is for adults over 18 who need spinal fusion surgery due to cervical spondylosis and haven't improved with other treatments. They must be able to follow the study plan, attend follow-ups, and not be pregnant or planning pregnancy for a year post-surgery. Exclusions include infection, substance abuse history, involvement in another study that affects results, certain bone diseases or allergies, severe obesity, legal issues related to spine conditions, excessive surgical risk factors like heart or lung disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo anterior cervical corpectomy and fusion with either Actifuse SHAPE or autograft with demineralized bone matrix
Follow-up
Participants are monitored for fusion rates and clinical outcomes post-surgery
Long-term follow-up
Participants may continue to be monitored for long-term outcomes beyond the primary follow-up period
What Are the Treatments Tested in This Trial?
Interventions
- Actifuse SHAPE
- Autograft with Demineralized Bone Matrix
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wayne State University
Lead Sponsor