Comparing two bone graft substitutes for lumbar spine fusion

A Prospective, Randomized, Intra-Patient Controlled, Multi-Center Clinical Investigation Evaluating OSTEOAMP SELECT Fibers Versus Infuse Bone Graft as Autograft Substitute in Lumbar Fusion Procedures

This study is testing if a new bone graft called OSTEOAMP SELECT Fibers works better and is safer than Infuse Bone Graft for patients having surgery to fuse their spine due to disc problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 101 (estimated)
• Ages: 21 Years to 80 Years
• Sex: All
• Sponsor: Bioventus LLC (Industry-sponsored)
• Locations: 9 sites (New Haven, Connecticut and 8 other locations)
• Trial ID: NCT05405374 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the effectiveness and safety of OSTEOAMP SELECT Fibers compared to Infuse Bone Graft in skeletally mature patients undergoing lumbar interbody fusion (LIF) for degenerative disc disease and related conditions. The study will utilize an intra-patient control model, where each participant serves as their own control by receiving both treatments at different levels of the spine. Effectiveness will be assessed by the lumbar interbody fusion rate at 12 and 24 months, while safety will be monitored through the documentation of adverse events related to the surgical procedure or product. The study will provide clinical evidence for the use of OSTEOAMP SELECT in spinal fusion procedures.

Who should consider this trial

Good fit: Ideal candidates are skeletally mature individuals aged 21 to 80 with symptomatic degenerative disc disease requiring fusion at two lumbar levels.

Not a fit: Patients who have not responded to non-operative treatments for less than six months or have severe spinal conditions beyond the study's scope may not benefit.

Why it matters

Potential benefit: If successful, this study could offer a more effective and safer bone graft substitute for patients undergoing lumbar spine fusion.

How similar studies have performed: Other studies have shown promise in using similar approaches for spinal fusion, but the specific use of OSTEOAMP SELECT is novel.

Eligibility criteria

Inclusion Criteria:

* Skeletally mature male or female patient, at least 21 years of age and no more than 80 years of age, inclusive, at the time of surgery;
* Has symptomatic degenerative disc disease (DDD) of the lumbosacral spine in two levels (L2 to S1). Lumbar DDD is defined as discogenic back pain with or without radicular symptoms confirmed by patient history and radiographic studies
* Has radiographic evidence (e.g. CT, MRI, x-ray, etc.) of degenerative lumbosacral disease including instability up to and including Grade 1 spondylolisthesis at the involved level(s)
* Requires fusion (i.e., symptomatic) at 2 adjacent or non-adjacent levels from L2 to S1;
* Non-responsive to non-operative treatment (e.g., bed rest, physical therapy, medication,spinal injection, manipulation, and/or TENS) for at least 6 months;
* 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.

Exclusion Criteria:

* Previous lumbar spine surgery with the exception of discectomy and/or laminectomy at the target levels.
* Lumbar scoliosis \>30 degrees.
* Documented history of osteoporosis, osteomalacia, Paget's disease or metabolic bone disease
* Morbidly obese, as defined by a Body Mass Index (BMI) \>40 kg/m2.
* Documented history of uncontrolled diabetes mellitus
* Presence of active malignancy or prior history of malignancy (non-invasive basal cell carcinoma of the skin is allowed).
* Overt or active bacterial infection, either local to surgical space or systemic.
* Chronic use of steroids (defined as more than 6 weeks of steroid use within 12 months of surgery, other than episodic use or inhaled corticosteroids)
* Co-morbidities, which in the investigator's opinion, precludes the subject from being a surgical candidate.
* Autoimmune disease, which in the investigator's opinion, is known to affect bone metabolism or the spine (e.g., spondyloarthropathies, juvenile arthritis, rheumatoid arthritis, Graves' disease, Hashimoto's thyroiditis).
* Any endocrine or metabolic disorder, which in the investigator's opinion, is known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers- Danlos syndrome, or osteogenesis imperfecta).
* History of hypersensitivity and/or allergy to any of the agents used to process OSTEOAMP SELECT, including bacitracin, polymyxin B sulfate, and gentamicin.
* Known hypersensitivity or allergy to any components of the study treatments including, but not limited to bone morphogenetic proteins (BMPs); injectable collagen; protein pharmaceuticals (e.g., monoclonal antibodies or gamma globulins); bovine collagen products; and/or instrumentation materials (e.g., titanium, titanium alloy, cobalt chrome,cobalt chrome alloy, or PEEK).
* Is a prisoner.
* Treatment with an investigational therapy (drug, device, and/or biologic) targeting spinal conditions within 3 months prior to implantation surgery, treatment with any other investigational therapies within 30 days prior to implantation surgery, or such treatment is planned during the 24-month period following implantation of the study treatment.
* Pregnant or nursing. Females of child-bearing potential must agree not to become pregnant for the duration of the study.
* A history of alcohol and/or drug abuse within 6 months prior to screening or exhibits evidence, in the investigator's opinion, of alcohol/drug abuse at screening.
* Current history of heavy nicotine use (e.g. more than 20 cigarettes per day).
* Any condition, which in the investigator's opinion, would interfere with the subject's ability to comply with study instructions, which might confound data interpretation.

Where this trial is running

New Haven, Connecticut and 8 other locations

• Yale University — New Haven, Connecticut, United States (Recruiting)
• Kansas Joint and Spine Specialists — Wichita, Kansas, United States (Recruiting)
• Orthopaedic Institute of Western Kentucky — Paducah, Kentucky, United States (Recruiting)
• Spine Institute of Louisiana — Shreveport, Louisiana, United States (Active_not_recruiting)
• New England Baptist Hospital — Boston, Massachusetts, United States (Recruiting)
• Tennessee Orthopaedic Alliance — Nashville, Tennessee, United States (Recruiting)
• Austin Neurosurgeons — Austin, Texas, United States (Recruiting)
• OrthoVirginia — Richmond, Virginia, United States (Recruiting)
• West Virginia University — Morgantown, West Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Amanda Doan

Conditions Lumbar Spine Disease; Lumbar Spondylolisthesis; Lumbar Spine Instability; Lumbar Spondylosis; Degenerative Disc Disease; Lumbar Interbody Fusion