Actifuse SHAPE vs Autograft for Spinal Cord Disease

Overseen By Diana Scanlon, RN, NP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wayne State University

Must not be taking: Steroids

Disqualifiers: Infection, Substance abuse, Obesity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: Surgery and immediate recovery

40 Participants Needed

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

My bones have finished growing.

My back treatment didn’t work, and I need surgery to fuse my spine.

I am not pregnant or nursing and agree to avoid pregnancy for 1 year after surgery.

Exclusion Criteria

I am currently on chemotherapy, radiation, or have been using steroids for more than 6 weeks in the past year.

I have a health condition that makes surgery too risky for me.

Subject is participating in another clinical study, which could confound results

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo anterior cervical corpectomy and fusion with either Actifuse SHAPE or autograft with demineralized bone matrix

Surgery and immediate recovery

Hospital stay for surgery

Follow-up

Participants are monitored for fusion rates and clinical outcomes post-surgery

24 months

Visits at 6 weeks, 6 months, 12 months, and 24 months

Long-term follow-up

Participants may continue to be monitored for long-term outcomes beyond the primary follow-up period

Optional extension

What Are the Treatments Tested in This Trial?

Interventions

• Actifuse SHAPE
• Autograft with Demineralized Bone Matrix

Trial Overview The trial is testing two types of bone graft substitutes in patients undergoing anterior cervical corpectomy (ACC) spinal fusion: Actifuse mixed with bone marrow aspirate versus autograft mixed with demineralized bone matrix. It aims to compare their effectiveness in achieving spinal fusion and improving clinical outcomes over a period of two years.

How Is the Trial Designed?

Group I: Autograft with Demineralized Bone Matrix Experimental Treatment 1 Intervention

autograft mixed with demineralized bone matrix in cervical spine fusion.

Group II: Actifuse SHAPE Experimental Treatment 1 Intervention

Actifuse Synthetic Bone Graft substitutes mixed with bone marrow aspirate in cervical spine fusion. Actifuse is a synthetic, porous, silicate-substituted hydroxyapatite and has shown that this maximizes a favorable bony response.

Who Is Running the Clinical Trial?

Wayne State University

Lead Sponsor

Trials

318

Recruited

111,000+