Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
101 participants
INTERVENTIONAL
2022-05-06
2025-10-31
Brief Summary
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Detailed Description
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Effectiveness will be based on the lumbar interbody fusion rate at the index levels assessed by a treatment-blinded independent reviewer at 12 months and 24 months.
Safety will be evaluated by documenting the number and nature of all (serious) adverse events that may in any way be related to the surgical procedure or product. The complication rate will be compared to the rate in control populations from literature.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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OSTEOAMP
OSTEOAMP SELECT Fibers as an autograft substitute in lumbar interbody fusion procedures
OSTEOAMP
OSTEOAMP SELECT Fibers (derived from human bone allograft) rehydrated with bone marrow aspirate (BMA) and combined with local autogenous graft for use in lumbar interbody fusion of the lumbar spine.
Infuse
The Infuse Bone Graft as an autograft substitute in lumbar interbody fusion procedures
Infuse
The Infuse Bone Graft/Medtronic Interbody Fusion Device consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2, known as dibotermin alfa) placed on an absorbable collagen sponge (ACS). rhBMP-2 is the active agent in the Infuse Bone Graft component. The ACS is a soft, white, pliable, absorbent implantable matrix for rhBMP-2.
Interventions
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OSTEOAMP
OSTEOAMP SELECT Fibers (derived from human bone allograft) rehydrated with bone marrow aspirate (BMA) and combined with local autogenous graft for use in lumbar interbody fusion of the lumbar spine.
Infuse
The Infuse Bone Graft/Medtronic Interbody Fusion Device consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2, known as dibotermin alfa) placed on an absorbable collagen sponge (ACS). rhBMP-2 is the active agent in the Infuse Bone Graft component. The ACS is a soft, white, pliable, absorbent implantable matrix for rhBMP-2.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
80 Years
ALL
No
Sponsors
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Bioventus LLC
INDUSTRY
Responsible Party
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Locations
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Yale University
New Haven, Connecticut, United States
Kansas Joint and Spine Specialists
Wichita, Kansas, United States
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, United States
Spine Institute of Louisiana
Shreveport, Louisiana, United States
New England Baptist Hospital
Boston, Massachusetts, United States
Tennessee Orthopaedic Alliance
Nashville, Tennessee, United States
Austin Neurosurgeons
Austin, Texas, United States
OrthoVirginia
Richmond, Virginia, United States
West Virginia University
Morgantown, West Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BGS-21-01
Identifier Type: -
Identifier Source: org_study_id
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