OSTEOAMP vs. Infuse for Degenerative Disc Disease

(SELECT Trial)

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

101 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this clinical study is to compare OSTEOAMP SELECT Fibers to Infuse Bone Graft, in terms of effectiveness and safety, when used as a bone graft substitute in in skeletally mature patients qualified for 2-lumbar interbody fusion (LIF) by means of an intra-patient control model.

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.

What data supports the effectiveness of the treatment OSTEOAMP and Infuse for Degenerative Disc Disease?

Research shows that demineralized bone matrix (DBM) products, like those used in OSTEOAMP, have been effective in promoting spinal fusion, which is important for treating degenerative disc disease. Additionally, Infuse (rhBMP-2) has been used as an alternative to traditional bone grafts, although there are concerns about its side effects and cost. ^{1 2 3 4 5}

Is the treatment with OSTEOAMP and Infuse generally safe for humans?

There are safety concerns with Infuse (rhBMP-2), including reports of complications like swelling, infection, and even cancer, especially when used in ways not approved by the FDA. OSTEOAMP is considered a viable alternative, but specific safety data for it is not detailed in the available research. ^{2 5 6 7 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Demineralized Bone Matrix in Spine Surgery: A Review of Current Applications and Future Trends. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

A comparison of commercially available demineralized bone matrix for spinal fusion. [2018]

3. Pakistan pubmed.ncbi.nlm.nih.gov

Comparison of Total Disc Replacement with lumbar fusion: a meta-analysis of randomized controlled trials. [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

Are injectable regenerative therapies effective in the treatment of degenerative disc disease? A systematic review. [2022]

5. England 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Dose-dependent toxicity of a commercially available demineralized bone matrix material. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

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