OSTEOAMP vs. Infuse for Degenerative Disc Disease

(SELECT Trial)

Not currently recruiting at 10 trial locations

Overseen By Pierce Nunley, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bioventus LLC

Must not be taking: Steroids

Disqualifiers: Osteoporosis, Diabetes, Malignancy, Autoimmune, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two bone graft substitutes, OSTEOAMP SELECT Fibers and Infuse Bone Graft, to determine which is more effective and safe for treating degenerative disc disease, a condition causing back pain due to worn-out spinal discs. It specifically targets patients requiring a two-level lumbar fusion surgery, a procedure to join two bones in the lower spine. Ideal participants have experienced degenerative disc disease symptoms between L2 and S1 for at least six months and have not improved with other treatments like physical therapy or medication. As an unphased trial, this study offers patients the opportunity to contribute to valuable research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research shows that OSTEOAMP SELECT Fibers hold promise as a substitute for bone grafts. Studies indicate that OSTEOAMP can help bones fuse, sometimes even faster than its competitor, Infuse. This suggests it is well-tolerated by patients undergoing spinal fusion surgeries.

The FDA has approved Infuse Bone Graft for certain uses. While generally safe, it carries possible side effects, such as inflammation and infection, which are common risks in spinal fusion surgeries.

Both treatments have demonstrated effectiveness in helping bones heal. However, considering potential side effects and discussing them with a healthcare provider is important. Each treatment has specific safety details, and understanding these can aid in making an informed decision about joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

OSTEOAMP is unique because it uses SELECT Fibers as an autograft substitute in lumbar interbody fusion procedures for degenerative disc disease. Unlike traditional bone grafts, OSTEOAMP is designed to enhance bone healing and regeneration by providing a matrix that supports cell attachment and growth. Researchers are excited about OSTEOAMP because it offers a promising alternative that could potentially improve patient outcomes by promoting faster and more effective bone fusion.

What evidence suggests that this trial's treatments could be effective for degenerative disc disease?

This trial will compare OSTEOAMP SELECT Fibers and Infuse Bone Graft for treating degenerative disc disease. Research has shown that OSTEOAMP SELECT Fibers can help bones fuse faster than Infuse Bone Graft in spine surgeries. Evidence suggests that OSTEOAMP is effective for both neck and lower back fusions, which may benefit those with degenerative disc disease. Meanwhile, studies have found that Infuse successfully promotes new bone growth where placed during lower back fusion surgeries. Clinical trials strongly support Infuse's ability to encourage bone formation. Both treatments have shown promise in aiding bone fusion, offering good options for patients with degenerative disc disease. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

Adults aged 21-80 with degenerative spinal conditions, specifically at two levels between L2 to S1, who haven't improved after 6 months of non-surgical treatments. Candidates must be able to follow the study's procedures and not have uncontrolled diabetes, active cancer, infections, severe allergies to treatment components, or a history of heavy smoking or substance abuse.

Inclusion Criteria

Willing and able to comply with the study protocol (including post-operative clinical and radiographic evaluations and required rehabilitation plan) and able to understand and sign the Informed Consent.

I am between 21 and 80 years old and my bones have stopped growing.

I have proof of lower back disease, including slight spine misalignment, from scans.

Exclusion Criteria

My health conditions make me ineligible for surgery, according to my doctor.

I am not allergic to any study treatment components like BMPs, collagen, or certain metals.

I haven't used experimental treatments for my spine or any other condition recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo lumbar interbody fusion procedures using either OSTEOAMP SELECT Fibers or Infuse Bone Graft

6 weeks

Pre-Op, 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple time points

24 months

3 month, 6 month, 12 month, 24 month

What Are the Treatments Tested in This Trial?

Interventions

• Infuse
• OSTEOAMP

Trial Overview

The trial is testing OSTEOAMP SELECT Fibers against Infuse Bone Graft for safety and effectiveness as bone graft substitutes in lumbar interbody fusion surgery. Each patient serves as their own control by receiving both treatments at different affected spine levels.

How Is the Trial Designed?

Group I: Infuse Active Control 1 Intervention

The Infuse Bone Graft as an autograft substitute in lumbar interbody fusion procedures

Group II: OSTEOAMP Active Control 1 Intervention

OSTEOAMP SELECT Fibers as an autograft substitute in lumbar interbody fusion procedures

OSTEOAMP is already approved in United States for the following indications:

Approved in United States as OSTEOAMP for:

• Degenerative disc disease
• Degenerative spondylolisthesis
• Lumbar spine instability
• Lumbar spondylosis

Who Is Running the Clinical Trial?

Bioventus LLC

Lead Sponsor

Trials

17

Recruited

15,200+

Published Research Related to This Trial

In a study involving 72 athymic nude rats, the demineralized bone matrix (DBM) product Osteofil showed the highest spinal fusion rate (14 out of 18) compared to Grafton (11 out of 17) and Dynagraft (0 out of 17), indicating significant variability in osteoinductive potential among different DBM products.

The study found that while Osteofil and Grafton had comparable fusion rates, Dynagraft failed to achieve any fusion, highlighting the importance of product selection in spinal surgery for effective grafting material.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of commercially available demineralized bone matrix for spinal fusion. Wang, JC., Alanay, A., Mark, D., et al.[2018]

In a study of 321 patients undergoing lumbar interbody fusion, OsteoAMP demonstrated significantly higher fusion rates at 6, 12, and 18 months compared to rhBMP-2, with about 70% fewer complications.

OsteoAMP not only achieved fusion approximately 40% faster than rhBMP-2, but it also resulted in 80.5% lower costs for osteobiologic supplies, making it a more economical and effective alternative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allogeneic morphogenetic protein vs. recombinant human bone morphogenetic protein-2 in lumbar interbody fusion procedures: a radiographic and economic analysis. Roh, JS., Yeung, CA., Field, JS., et al.[2022]

In a study involving athymic rats, high doses of Grafton demineralized bone matrix containing glycerol resulted in a dose-dependent increase in mortality, with the highest dose leading to the death of all rats within 72 hours.

The median lethal dose of Grafton putty was found to be 0.00469 mL/g body weight, indicating that the glycerol component may pose a significant risk of acute renal failure, suggesting that clinical use should be limited to no more than 2 mL/kg body weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-dependent toxicity of a commercially available demineralized bone matrix material. Wang, JC., Kanim, LE., Nagakawa, IS., et al.[2019]

Recombinant human bone morphogenetic protein-2 (rhBMP-2), marketed as INFUSE Bone Graft, is FDA-approved for local delivery in spinal fusion to promote bone growth and reduce back pain, demonstrating its efficacy in treating degenerative disc issues.

The product is applied using a collagen sponge in a titanium cage, and ongoing clinical evaluations are exploring new carriers for rhBMP-2 that could enhance its release and effectiveness in various bone grafting applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local sustained delivery of recombinant human bone morphogenetic protein-2 (rhBMP-2). McKay, B.[2020]

The off-label use of BMP/INFUSE in spine surgery has been linked to serious adverse events, including dysphagia, hematoma, and the need for intubation, as warned by the FDA in 2008.

Recent studies have highlighted that adverse events such as heterotopic ossification, infection, and retrograde ejaculation are under-reported, indicating significant perioperative and postoperative risks associated with BMP/INFUSE in spinal fusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications due to the use of BMP/INFUSE in spine surgery: The evidence continues to mount. Epstein, NE.[2022]

Injectable regenerative therapies, such as mesenchymal stem cells (MSC) and platelet-rich plasma (PRP), have shown significant clinical improvement in patients with degenerative disc disease, based on a systematic review of 17 studies involving 380 patients.

No major complications or adverse effects were reported from these treatments, indicating a good safety profile, although none of the studies demonstrated improvements in disc height on imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are injectable regenerative therapies effective in the treatment of degenerative disc disease? A systematic review. DI Martino, A., Barile, F., Fiore, M., et al.[2022]

Demineralized bone matrix (DBM) and demineralized bone fibers (DBF) have shown similar fusion rates to traditional iliac crest autografts in spine surgery, although most studies are of lower evidence quality (level III or IV).

DBM and DBF can enhance traditional grafting techniques by increasing graft volume and potentially promoting new bone formation, but caution is advised when using them as standalone products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Demineralized Bone Matrix in Spine Surgery: A Review of Current Applications and Future Trends. Shepard, NA., Rush, AJ., Scarborough, NL., et al.[2021]

Total Disc Replacement (TDR) is more effective than lumbar fusion for treating Degenerative Disc Disease (DDD), showing significant improvements in disability scores, patient satisfaction, and reduced narcotic use over a 2-year follow-up period based on a meta-analysis of six randomized controlled trials.

Patients who underwent TDR reported a higher overall success rate and were more likely to choose the same surgical treatment again, while also experiencing fewer complications compared to those who had lumbar fusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Total Disc Replacement with lumbar fusion: a meta-analysis of randomized controlled trials. Nie, H., Chen, G., Wang, X., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11800106/

A systematic review of bone graft products used in lumbar ...

This systematic review (SR) intends to validate and consolidate the existing evidence base supporting bone graft materials related to lumbar interbody fusion ...

2.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf/p000058b.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA

The following is a list of potential adverse events which may occur with spinal fusion surgery with the InFUSE™ Bone Graft/LT-CAGE™ Lumbar ...

3.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf/p000054c.pdf

INFUSE Bone Graft

INFUSE Bone Graft induces new bone tissue at the site of implantation. Based on data from non-clinical studies, the bone formation process develops from the ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01415908

INFUSE®Bone Graft in Transforaminal Lumbar Interbody ...

This investigation will provide safety and effectiveness information on the use of INFUSE® Bone Graft with the CAPSTONE® Spinal System and CD HORIZON® ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11346822/

A Narrative Review on Recombinant Human Bone ...

This paper reviews the development, clinical application, and controversies surrounding the use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in ...

6.

medtronic.com

medtronic.com/en-us/l/isw/infuse-bone-graft-indications-safety-warnings.html

Infuse Bone Graft - Indications, Safety, and Warnings

View indications, safety, and warnings for Infuse Bone Graft - recombinant human bone morphogenetic protein-2 (rhBMP-2) applied to an absorbable collagen ...