Actifuse ABX Versus INFUSE in Posterolateral Instrumented Lumbar Fusion (PLIF) With Interbody Fusion

- Has degenerative disc disease of the lumbar spine as indicated by back pain of discogenic/degenerative origin, with or without leg pain, and has one or more of the following conditions as documented by plain X-rays, CT scan or MRI scan:

- Has a preoperative Oswestry Back Disability Score of 30 or more.

- Aged 18 to 75 years and skeletally mature at time of surgery.

- Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications and/or spinal injections) for a period of six months.

- If of childbearing potential, patient is non-pregnant, non-nursing and agrees not to become pregnant for one year following surgery.

- Is willing to and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.

- Has had previous failed attempts at fusion surgery at the involved level(s).

- Has a diagnosis of spinal infection tumour or trauma.

- Requires surgery at more than two (2) levels.

- Has osteoporosis (excluding osteopenia) as evidenced on plain X-rays, CT scans (or DEXA scan in cases of doubt).

- Is pregnant.

- Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse.

- Has received drugs that may interfere with bone metabolism within two weeks prior to the planned surgery date (e.g., steroids or methotrexate) excluding routine perioperative, non-steroidal anti-inflammatory drugs.

- Has a history of autoimmune disease.

- Has a history of exposure to injectable collagen implants.

- Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.

- Has received treatment with an investigational therapy (device and/or pharmaceutical) within 30 days prior to surgery or such treatment is planned during the 24 months following surgery.

- Has received any previous exposure to any/all BMPs of either human or animal extraction.

- Has a history of allergy to bovine products or a history of general anaphylaxis.

- Has a history of any endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal oseodystrophy, Ehlos-Danlos syndrome or osteogenesis imperfecta).

- Has any disease that would preclude accurate clinical evaluation (e.g., neuromuscular disease, etc.).

- Has a primary diagnosis of a spinal disorder other than degenerative disc disease or other conditions as set out in "inclusions" above at the involved level(s).

- Has a condition that requires postoperative medications that interfere with fusion, such as steroids or prolonged use of non-steroidal anti-inflammatory drugs, excluding routine perioperative non-steroidal anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation.

- Has overt or active bacterial infection, local or systemic, and/or a potential for bacteremia.

- Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).

- Has a documented metal allergy or intolerance to titanium alloy or cobalt-chrome-molybdenum alloy.

- Is, in the opinion of the Principal Investigator or Co-Investigators, intellectually unable to co-operate with the study.

- Has chronic or acute renal and/or hepatic failure or prior history of renal or hepatic disease.