Comparison of Actifuse ABX and Local Bone in Spinal Surgery

Recruiting in Palo Alto (17 mi)

Overseen by Safdar Khan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Ohio State University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study is being done to compare people who had a standard of care spinal fusion using part of their local bone graft (a small amount of bone from the region of the spine where the fusion is occurring) to correct an adult spinal deformity and people who will have a standard of care spinal fusion using a mixture of Actifuse ABX® (a market approved bone graft substitute) and a local bone graft (a small amount of bone from the region of the spine where the fusion is occurring). This study will compare the outcomes of both groups to help the Orthopaedic surgeon conducting spinal fusions in the future. Investigators expect that Actifuse ABX® will be as good if not better than just a local bone graft.

Eligibility Criteria

Inclusion Criteria

Patient aged 18 to 80

Patient received primary diagnosis of adult spinal deformity (with fusion of >2 levels)

Patient is a candidate for multi-level posterior lumbar fusion

Participant Groups

Group I: Multilevel Spinal Fusion w/ Actifuse ABX® Experimental Treatment 1 Intervention

An osteostimulatory,phase pure,porous,silicate substituted calcium phosphate bone graft substitute used during multilevel spinal fusion.

Group II: Multilevel Spinal Fusion Active Control 1 Intervention

Multilevel spinal fusion without Actifuse ABX.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The Ohio State University Columbus, OH

Who Is Running the Clinical Trial?

Ohio State University Lead Sponsor

Baxter Healthcare Corporation Industry Sponsor

References