INFUSE® Bone Graft and MASTERGRAFT® Granules With CD HORIZON® for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease - Pilot Study

Inclusion criteria

• Has degenerative disc disease as 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], functional deficit and/or neurological deficit) and radiographic studies (e.g.,C T, MRl, X-Ray,etc.) to include one or more of the following:

• instability (defined as angulation ≥ 5° and/or translation ≥ 4mm,based on flexion/extension 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 6 months.
• If of child-bearing potential, patient is non-pregnant,non-nursing,and agrees to use adequate contraception for 1 year 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 Grade 1 or less spondylolisthesis at the involved level.
• Had previous spinal fusion surgical procedure at the involved level or an adjacent level.
• Requires spinal fusion at more than one lumbar level.
• Has a condition which requires postoperative medications that interfere with fusion, such as steroids or prolonged use of nonsteroidal anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation.
• Has a documented history of osteopenia or osteomalacia.
• Has any of the following that may be associated with diagnosis of osteoporosis (if "Yes" to any of the below risk factors,a dual x-ray absorptiometry (DEXA) scan will be required to determine eligibility.)

• Postmenopausal non-black female over 60 years of age and weighs less than 140 pounds.
• Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture.
• Male over the age of 70.
• Male over the age of 60 that has sustained a non-traumatic hip or spine fracture. If the level of BMD is a T score of -3.5 or a T score of -2.5 with vertebral crush fracture,then the patient is excluded from the study.
• Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
• Has overt or active bacterial infection, either local or systemic.
• 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 or alcohol and/or drug abuse.
• ls 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., steroids or methotrexate).
• Has a documented history of autoimmune disease ( e.g. Systemic Lupus Erythematosus or dermatomyositis).
• Has a history of exposure to implanted collagen or silicone implants.
• Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
• 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/ACS/MASTERGRAFT® Granules implantation.
• Has received any previous exposure to any/all BMP's of either human or animal extraction.
• Has a history of allergy to bovine products or a history of anaphylaxis.
• Has a history of endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease,renal osteodystrophy, Ehlers- Danlos syndrome,or osteogenesis imperfecta).