Pilot Study of rhBMP/BCP With or Without the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease

Inclusion criteria

• Has degenerative disc diseases noted by back pain of discogenic origin,with or without leg pain, with degeneration of the disc confirmed by patient history ( e.g., pain [leg, back, or symptoms in the sciatic nerve distribution] function deficit and/or neurological deficit) and radiographic studies ( e.g., CT, MRl, X-Ray,etc.) to include one or more of the following:

• instability (defined as angular motion > 5° and/or translation > 4 mm, based on Flex/Ext radiographs);
• osteophyte formation;
• decreased disc height;
• thickening of ligamentous tissue;
• disc degeneration or herniation; and/or
• facet joint degeneration.
• Has preoperative Oswestry score > 30.
• Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW,1932.).
• Requires fusion of a single level disc space from L1 to S1.
• Is at least 18 years of age, inclusive, at the time of surgery.
• Has not responded to non-operative treatment ( e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of at least 6 months.
• If female of child-bearing potential, who is not pregnant or nursing, and who agrees to use adequate contraception for 16 weeks following surgery.
• Is willing and able to comply with the study plan and sign the Patient Informed Consent Form.

Exclusion criteria

• Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade1 or less spondylolisthesis at the involved level.
• Had previous spinal fusion surgical procedure at the involved level.
• Require spinal fusion at more than one lumbar level.
• Has a condition which requires postoperative medications that interfere with fusion, such as steroids.
• Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
• Has presence of active malignancy.
• Has overt or active bacterial infection, either local or systemic.
• Is grossly obese, i.e., weight > 40% over ideal for their age and height.
• Has fever ( temperature >101°F oral) at the time of surgery.
• Has a documented titanium alloy allergy or intolerance.
• Is mentally incompetent. If questionable, obtain psychiatric consult.
• Has a Waddell Signs of Inorganic Behavior score of 3 or greater.
• Is a prisoner.
• Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug usage.
• Is a tobacco user at the time of surgery.
• Has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., NSAIDS, steroids or methotrexate).
• Has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
• Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins).
• Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following rhBMP-2/BCP implantation.
• Has received any previous exposure to any/all BMPs of either human or animal extraction.
• Has a history of severe allergy (anaphylaxis).
• Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers- Danlos syndrome, or osteogenesis imperfecta).