#Infuse bone skin

Medtronic Infuse Bone Graft substitutes containing recombinant proteins or synthetic peptides In a safety alert issued Jan.

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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.

Current history of heavy nicotine use (e.g.

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.

Females of child-bearing potential must agree not to become pregnant for the duration of the study.

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.

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).History of hypersensitivity and/or allergy to any of the agents used to process OSTEOAMP SELECT, including bacitracin, polymyxin B sulfate, and gentamicin.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).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).

Co-morbidities, which in the investigator's opinion, precludes the subject from being a surgical candidate.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).Overt or active bacterial infection, either local to surgical space or systemic.

#Infuse bone skin

Presence of active malignancy or prior history of malignancy (non-invasive basal cell carcinoma of the skin is allowed).

Documented history of uncontrolled diabetes mellitus.

Morbidly obese, as defined by a Body Mass Index (BMI) >40 kg/m2.

Documented history of osteoporosis, osteomalacia, Paget's disease or metabolic bone disease.

Previous lumbar spine surgery with the exception of discectomy and/or laminectomy at the target levels.

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.

Non-responsive to non-operative treatment (e.g., bed rest, physical therapy, medication,spinal injection, manipulation, and/or TENS) for at least 6 months.

Requires fusion (i.e., symptomatic) at 2 adjacent or non-adjacent levels from L2 to S1.

CT, MRI, x-ray, etc.) of degenerative lumbosacral disease including instability up to and including Grade 1 spondylolisthesis at the involved level(s) Lumbar DDD is defined as discogenic back pain with or without radicular symptoms confirmed by patient history and radiographic studies

Has symptomatic degenerative disc disease (DDD) of the lumbosacral spine in two levels (L2 to S1).

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.

Every subject will serve as his/her own control.Ī Prospective, Randomized, Intra-Patient Controlled, Multi-Center Clinical Investigation Evaluating OSTEOAMP SELECT Fibers Versus Infuse Bone Graft as Autograft Substitute in Lumbar Fusion Procedures The assignment of the bone graft product to each treated motion segment will be randomized in a 1:1 ratio. One of the levels will be grafted with OSTEOAMP SELECT and the other with Infuse housed within the same type of interbody cage. In this study, all subjects will be treated at 2 levels of the anterior lumbar spine. Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Why Should I Register and Submit Results?.