toreupdate.blogg.se - Infuse bone

#Infuse bone skin

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?.Department of Justice into their marketing and promotion of the Infuse bone substitute for uses that were not approved by the FDA and a Medtronic class action lawsuit has been filed by investors alleging that the company failed to disclose the extent to which their sales of the bone graft are tied to off-label use.

currently faces an investigation from the U.S. The Infuse bone substitute problems typically occur within 2 to 14 days after surgery, and for some patients the complications have resulted in tracheotomies, insertion of feeding tubes and additional surgery to drain implant sites.Īt the North American Spine Society’s 23rd annual meeting, researchers from the Cleveland Clinic presented data that quantifies the on and off-label use of the bone graft substitute, finding that 17.3% of all Medtronic Infuse bone substitute use was off-label. The close proximity of the cervical spine to the airway, could result in difficulty speaking, trouble swallowing and respiratory distress if swelling of the neck compresses the airway and nerves after an Infuse implant. In July 2008, the FDA issued a warning to healthcare providers highlighting a number of serious and life-threatening complications associated with use of BMP bone grafts in the cervical spine.