OSTEOAMP Lumbar Fusion Intra-Patient Controlled Study

Launched by BIOVENTUS LLC · Jun 1, 2022

Keywords

ClinConnect Summary

The OSTEOAMP Lumbar Fusion study is looking to compare two treatments used to help heal the spine in patients with certain back problems. Specifically, it will compare a new product called OSTEOAMP SELECT Fibers to a traditional bone graft material. This study is for adults aged 21 to 80 who have ongoing back pain due to issues like degenerative disc disease or instability in the spine and have not found relief from other treatments like physical therapy or medication.

Participants in the study will undergo a surgical procedure to fuse two levels of their spine. If you qualify, you can expect to be carefully monitored before and after surgery to see how well each treatment works and to ensure your safety. It's important to note that certain conditions, like previous spine surgery or severe obesity, may make you ineligible to participate. Overall, this study aims to find out which treatment might be more effective in helping patients recover from serious spine issues.

Gender

ALL

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.