OSTEOAMP vs. Infuse for Degenerative Disc Disease
(SELECT Trial)
Recruiting in Palo Alto (17 mi)
+10 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Bioventus LLC
Must not be taking: Steroids
Disqualifiers: Osteoporosis, Diabetes, Malignancy, Autoimmune, others
No Placebo Group
Approved in 1 Jurisdiction
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.
12345Is 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.
25678Eligibility 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.
+3 more
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.
+16 more
Trial 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
Participant Groups
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.
2Treatment groups
Active Control
Group I: InfuseActive Control1 Intervention
The Infuse Bone Graft as an autograft substitute in lumbar interbody fusion procedures
Group II: OSTEOAMPActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Yale UniversityNew Haven, CT
New England Baptist HospitalBoston, MA
Austin NeurosurgeonsAustin, TX
OrthoVirginia (Herzog Orthopedics)Richmond, VA
More Trial Locations
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Who Is Running the Clinical Trial?
Bioventus LLCLead Sponsor
References
Demineralized Bone Matrix in Spine Surgery: A Review of Current Applications and Future Trends. [2021]Graft augmentation for spinal fusion is an area of continued interest, with a wide variety of available products lacking clear recommendations regarding appropriate use. While iliac crest autograft has long been considered the "gold standard", suboptimal fusion rates along with harvest-related concerns continue to drive the need for graft alternatives. There are now multiple options of products with various characteristics that are available. These include demineralized bone matrix (DBM) and demineralized bone fibers (DBF), which have been used increasingly to promote spine fusion. The purpose of this review is to provide an updated narrative on the use of DBM/DBF in spine surgery.
A comparison of commercially available demineralized bone matrix for spinal fusion. [2018]In an effort to augment the available grafting material as well as to increase spinal fusion rates, the utilization of a demineralized bone matrix (DBM) as a graft extender or replacement is common. There are several commercially available DBM substances available for use in spinal surgery, each with different amounts of DBM containing osteoinductive proteins. Each product may have different osteoinductivity potential due to different methods of preparation, storage, and donor specifications. The purpose of this study is to prospectively compare the osteoinductive potential of three different commercially available DBM substances in an athymic rodent spinal fusion model and to discuss the reasons of the variability in osteoinductivity. A posterolateral fusion was performed in 72 mature athymic nude female rats. Three groups of 18 rats were implanted with 1 of 3 DBMs (Osteofil, Grafton, and Dynagraft). A fourth group was implanted with rodent autogenous iliac crest bone graft. The rats were sacrificed at 2, 4, 6, and 8 weeks. A dose of 0.3 cm(3) per side (0.6 cm(3)per animal) was used for each substance. Radiographs were taken at 2 weeks intervals until sacrifice. Fusion was determined by radiographs, manual palpation, and histological analysis. The Osteofil substance had the highest overall fusion rate (14/18), and the highest early 4 weeks fusion rate of (4/5). Grafton produced slightly lower fusion rates of (11/17) overall, and lower early 4 weeks fusion rate of (2/5). There was no statistically significant difference between the rate of fusion after implantation of Osteofil and Grafton. None of the sites implanted with Dynagraft fused at any time point (0/17), and there was a significantly lower fusion rate between the Dynagraft and the other two substances at the six-week-time point and for final fusion rate (P = 0.0001, Fischer's exact test). None of the autogenous iliac crest animals fused at any time point. Non-decalcified histology confirmed the presence of a pseudarthrosis or the presence of a solid fusion, and the results were highly correlated with the manual testing. Although all products claim to have significant osteoinductive capabilities, this study demonstrates that there are significant differences between some of the tested products.
Comparison of Total Disc Replacement with lumbar fusion: a meta-analysis of randomized controlled trials. [2022]A meta-analysis was performed to evaluate whether a beneficial clinical effect of the Total Disc Replacement (TDR) over lumbar fusion for the treatment of patients with Degenerative Disc Disease (DDD). An electronic search of PubMed, Cochrane Central Register of Controlled Trials, and EMBASE from their inception to 2012 was completed, and we assessed risk bias and retrieved relevant data, and meta-analysis was performed, if appropriate. Oswestry Disability Index (ODI), Visual Analog Score (VAS), patient satisfaction or VAS patient satisfaction, narcotic use, overall success rate, reoperation rate, work status, "surgery again?", complications and radiographic outcomes were evaluated. Six RCTs were included in this meta-analysis. At 2 years, TDR was demonstrated to be more beneficial for patients compared to lumbar fusion in the following outcomes, including ODI scores (MD:-4.87, 95% CI: -7.77 to -1.97, p=0.001), patient satisfaction (OR:1.91, 95% CI: 1.27 to 2.86, p=0.002) and VAS patient satisfaction (MD:9.10, 95% CI: 3.20 to 14.99, p=0.002), the percentage of using narcotics (OR=0.54, 95%CI: 0.31 to 0.96, p=0.03), overall success rate (OR:1.68, 95% CI: 1.26 to 2.25, p=0.005), the rate of patients to chose the same surgical treatment again (OR:2.38, 95% CI: 1.72 to 3.28, p
Are injectable regenerative therapies effective in the treatment of degenerative disc disease? A systematic review. [2022]Degenerative disc disease is a major health concern in spine surgery. The aim of this systematic review was to summarize the current knowledge about injectable regenerative therapies (mesenchymal stem cells [MSC] or platelet rich plasma [PRP]) in degenerative disc disease.
Allogeneic morphogenetic protein vs. recombinant human bone morphogenetic protein-2 in lumbar interbody fusion procedures: a radiographic and economic analysis. [2022]Since the introduction of rhBMP-2 (Infuse) in 2002, surgeons have had an alternative substitute to autograft and its related donor site morbidity. Recently, the prevalence of reported adverse events and complications related to the use of rhBMP-2 has raised many ethical and legal concerns for surgeons. Additionally, the cost and decreasing reimbursement landscape of rhBMP-2 use have required identification of a viable alternative. Osteo allogeneic morphogenetic protein (OsteoAMP) is a commercially available allograft-derived growth factor rich in osteoinductive, angiogenic, and mitogenic proteins. This study compares the radiographic fusion outcomes between rhBMP-2 and OsteoAMP allogeneic morphogenetic protein in lumbar interbody fusion spine procedures.
Dose-dependent toxicity of a commercially available demineralized bone matrix material. [2019]A relative risk assessment was performed to determine the safety of three commercially available Grafton demineralized bone matrix quantities used in athymic rats.
Local sustained delivery of recombinant human bone morphogenetic protein-2 (rhBMP-2). [2020]Local delivery of recombinant human bone morphogenetic protein-2 (rhBMP-2) as a bone graft substitute in spinal fusion was Food and Drug Administration approved on July 2, 2002. Its commercial trade name is INFUSE Bone Graft. It was cleared as a combination biologic device after petitioning the FDA in the early 1990s with the argument that rhBMP-2's effects were only local and not systemic. The protein is applied to a type I collagen sponge at the time of surgery. After a minimum of 15 minutes to allow binding, the collagen sponge is rolled up and placed into a titanium spinal fusion cage. Two of the rhBMP-2 loaded cages are implanted into an intervertebral spinal disc space to promote bone growth across the disc, i.e., spinal fusion. Fusion stops motion at the treated level and ultimately reduces back pain originating from the degenerated disc. This same product was FDA approved for a tibia long bone fresh fracture bone grafting application in August 2004, and for sinus elevation and alveolar defects associated with extraction sockets in March 2007. In addition, a new carrier is under clinical evaluation that will offer longer rhBMP-2 sustained release and compression resistance, further expanding the clinical utility of rhBMP-2.
Complications due to the use of BMP/INFUSE in spine surgery: The evidence continues to mount. [2022]Increasingly, adverse events (AE) attributed to utilizing BMP/INFUSE (Bone Morphogenetic Protein, Medtronic, Memphis, TN, USA) "off-label" in spine surgery are being reported. In 2008, the Food and Drug Administration (FDA) issued a warning that in anterior cervical spine surgery, the "off-label" use of BMP/INFUSE contributed to marked dysphagia, hematoma, seroma, swelling, and/or the need for intubation/tracheostomy. Subsequent studies have cited the following AE; heterotopic ossification (HO), osteolysis, infection, arachnoiditis, increased neurological deficits, retrograde ejaculation, and cancer. Furthermore, in 2011, Carragee et al. noted that 13 of the original industry-sponsored BMP/INFUSE spinal surgery studies failed to acknowledge multiple AE. Additionally, in 2012, Comer et al. observed that the frequency of retrograde ejaculation reported for BMP/INFUSE used "on-label" to perform Anterior Lumbar Interbody Fusion/Lumbar Tapered Fusion-Cage Device (ALIF/LT-Cage) was also largely "under-reported." To summarize, there is mounting evidence in the spinal literature that utilizing BMP/INFUSE in spinal fusions contributes to major perioperative and postoperative morbidity.