A Study of Infuse® Bone Graft With Mastergraft® Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi...
The purpose of this study is to obtain safety and effectiveness data on the investigational device for multi-level PLF procedures and determine the most appropriate rhBMP-2 dose for use in this indication. The study information may be used for a potential pivotal study design.
A Prospective, Randomized, Multi-Center, Open-Label Pilot Study of Infuse® Bone Graft With Mastergraft® Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal Conditions
Multi-Level Degenerative Lumbosacral Spinal Conditions Disease Infuse Bone Graft Medtronic DBM
You can join if…
Open to people ages 21 years and up
- Degenerative lumbar spine condition:
- Requiring a PLF procedure using a bilateral metallic screw and rod system in 2-4 consecutive levels from L2-S1; and
- Diagnosed with: instability (up to and including Grade 2 spondylolisthesis, retrolisthesis, or lateral listhesis), stenosis with documented pre-operative instability, and/or recurrent disc herniation, any of which may have possible concomitant lumbar degenerative deformity (Cobb angle ≤ 30 degrees).
- Preoperative ODI score ≥40.
- Preoperative pain score of ≥8 (out of 20) on the Preoperative Leg Pain Questionnaire.
- Most inferior treated spinal level is able to accommodate an interbody fusion device.
- ≥21 years of age at the time of signing the informed consent.
- Failed ≥6 months non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS).
- Is willing and able to comply with the study plan and able to understand and sign the Subject Informed Consent Form.
You CAN'T join if...
- Prior spinal fusion surgical procedure at the involved or adjacent spinal levels. (Prior non-fusion surgery at the target levels, including discectomy and/or single-level foraminotomy or laminectomy, is allowed.)
- Prior lumbar disc arthroplasty.
- Significant lumbar instability, defined as sagittal listhesis >Grade 2 at any involved level using Meyerding's Classification or lateral listhesis >25% lateral translation at any involved level.
- Planned use of an internal or external bone growth stimulator.
- Lumbar scoliosis >30 degrees.
- Osteoporosis to a degree that spinal instrumentation is contraindicated or a history of atraumatic vertebral fracture.
- Morbidly obese, as defined by a Body Mass Index (BMI) >40.
- Presence of active malignancy or prior history of malignancy.
- Overt or active bacterial infection, either local or systemic.
- . Has undergone systemic administration of any type of corticosteroid, anti-neoplastic, immunostimulating, or immunosuppressive agents within 30 days prior to implantation of the assigned treatment.
- . Comorbidities precluding subject from being a surgical candidate.
- . History of autoimmune disease known to affect bone metabolism or the spine (e.g., spondyloarthropathies, juvenile arthritis, rheumatoid arthritis, Graves' disease, Hashimoto's thyroiditis).
- . History of any endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).
- . History of exposure to any recombinant proteins used for bone formation (i.e., Infuse Bone Graft, OP-1 Putty, OP-1 Implant, AUGMENT Bone Graft, GEM21S, i-FACTOR Peptide Enhanced Bone Graft, or PepGen P-15 Synthetic Bone Graft).
- . 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; gentamicin or glycerol (which may be present in trace amounts in the DBM products); and/or instrumentation materials (titanium, titanium alloy, cobalt chrome, cobalt chrome alloy, or polyetheretherketone [PEEK]).
- . History of any allergy resulting in anaphylaxis.
- . Is a prisoner.
- . Is mentally incompetent. If questionable, obtain psychiatric consult.
- . Treatment with an investigational therapy (drug, device, and/or biologic) 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 one year following surgery.
- . Any condition that would interfere with the subject's ability to comply with study instructions, might confound the interpretation of the study, or put the subject at risk.
- University of California, Davis
in progress, not accepting new patients
Sacramento California 95816 United States
- Spine Colorado
in progress, not accepting new patients
Durango Colorado 81301 United States