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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments for cervical spondylotic myelopathy, a condition causing neck pain and spinal issues. The study compares a synthetic bone graft substitute, Actifuse SHAPE mixed with bone marrow, to a traditional method using an autograft mixed with demineralized bone. The goal is to determine which treatment improves spinal fusion surgery outcomes. Candidates who have tried other treatments without success and are eligible for spinal fusion surgery might be a good fit for this trial. As an unphased trial, it offers patients the chance to explore innovative treatment options that might enhance their surgical outcomes.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it excludes those taking medications that may interfere with bone or soft tissue healing, including chronic steroid use. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Actifuse SHAPE is generally safe for spinal fusion surgeries. Studies indicate it has a high success rate in helping bones heal together. Actifuse is made from a synthetic material that mimics natural bone and is combined with bone marrow aspirate to promote bone growth.

Patients have tolerated Actifuse SHAPE well, with few side effects reported. It has been used in surgeries for over ten years, supporting its safety, as it has been used many times without major safety concerns.

The other treatment in the study uses an autograft mixed with demineralized bone matrix (DBM). An autograft involves taking bone from another part of the patient's body. This method is commonly used and is known to be safe and effective.

Both treatment options in this clinical trial have strong safety records. Past studies have shown they are well-tolerated, making them promising options for patients needing spinal fusion surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard autograft with demineralized bone matrix used in spinal cord disease treatments, Actifuse SHAPE integrates a synthetic, porous, silicate-substituted hydroxyapatite. This unique composition is designed to maximize a favorable bone response, potentially enhancing bone growth and healing. Researchers are excited about Actifuse SHAPE because it combines a cutting-edge material with bone marrow aspirate, which might improve the effectiveness of cervical spine fusion procedures.

What evidence suggests that this trial's treatments could be effective for cervical spondylotic myelopathy?

This trial will compare Actifuse SHAPE with Autograft and Demineralized Bone Matrix (DBM) for spinal fusion surgeries. Research has shown that Actifuse SHAPE effectively promotes bone growth using a man-made material. In contrast, the Autograft with DBM combines the patient's own bone with specially treated bone material. Both methods aim to encourage new bone growth and aid in healing. Actifuse has over 10 years of clinical experience, with positive results observed 12 months after surgery. ^{1 3 4 5 6}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02005081

NCT02005081 | Baxter: Actifuse SHAPE vs DBX in ACC This study will assess the fusion rates along with the clinical outcomes for the use of Actifuse Synthetic Bone Graft substitutes mixed with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4910791/

Comparison of Two Synthetic Bone Graft Products in a ... In conclusion, this study has demonstrated the efficacy of Signafuse as a viable standalone replacement for ICBG in spinal fusion procedures ...

3. researchgate.net researchgate.net/publication/384821790_Effective_use_of_actifuse_shape_in_spinal_fusion_A_retrospective_chart_review

Effective use of actifuse shape in spinal fusion Conclusions Actifuse Shape is safe and is associated with high rate of bony fusion when implanted as the primary bone graft substitute in spinal fusion ...

4. withpower.com withpower.com/trial/phase-spondylosis-9-2013-2d289

Actifuse SHAPE vs Autograft for Spinal Cord Disease 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 ...

5. advancedsurgery.baxter.com advancedsurgery.baxter.com/actifuse

ACTIFUSE Bone Graft Substitute Backed by 10 years of clinical experience and level 2 clinical evidence showing successful bone fusion results at 12 months, ACTIFUSE offers orthopedic surgeons ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8092936/

Allografts and Spinal Fusion - PMC This paper focuses on allografts and provides an overview on the different subtypes with an emphasis on recent product development and uses in spinal fusion ...