Pilot Study of rhBMP-2/ACS/LT-CAGE® for Anterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease

Inclusion criteria

• Has degenerative disc disease as noted by back pain of discogenic origin with degeneration of the disc confirmed by radiographic studies.
• Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW, 1932.)
• Has single level symptomatic degenerative involvement from L2 to S1.
• Is between the ages of 18 and 65, inclusive, at the time of surgery.
• Is willing to comply with the study plan and sign the Patient Informed Consent Form.
• Has not responded to conservative treatment for a period of 5 months.
• If of child-bearing potential, subject is non-pregnant (documented by a negative Pregnancy test within 72 hours of surgery), non-nursing female who agrees to use adequate contraception for 16 weeks following surgery

Exclusion criteria

• Has spinal condition other than symptomatic degenerative disc disease at the involved surgical level.
• Had previous anterior surgical procedures at the involved spinal level.
• Has a condition which requires postoperative medications that interfere with fusion such as steroids or nonsteroidal anti-inflammatory drugs. (This does not include low dose aspirin for prophylactic anticoagulation.)
• Has osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
• Has circulatory problems, such as thrombophlebitis, lymphedema, or vascular deficiency at the implant site.
• Has symptomatic cardiac disease.
• Has presence of active malignancy or history of cancer in the past 5 years.
• Has overt or active infection.
• Is obese, i.e., weight greater than 40% over ideal for their age and height.
• Has fever (temperature > 101°F oral).
• Has local inflammatory signs indicative of infection.
• Has a documented metal allergy or intolerance.
• Is involved in a worker's compensation or unresolved spinal litigation case.
• Is mentally incompetent (either documented or in the opinion of the investigator).
• Has psychogenic magnification of pain (in the opinion of the investigator).
• Is a prisoner.
• Is pregnant.
• Is an alcohol and/or substance abuser.
• Requires bone growth stimulation in the lumbar spine.
• Is a tobacco user at the time of surgery.
• Patient 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).
• Patient has a history of autoimmune disease (systemic lupus erythematosus or dermatomyositis).
• The subject has a history of exposure to injectable collagen implants.
• Patient's history includes hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
• Patient 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 implantation.
• Patient has received any previous exposure to BMP.
• The patient requires allograft or bone substitute as part of treatment.
• Patient has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).
• Patient in the physician's opinion, would not be a good candidate for this surgical procedure.