Actifuse ABX Versus INFUSE in Posterolateral Instrumented Lumbar Fusion (PLIF) With Interbody Fusion (APPRAISET1)

Inclusion Criteria:

• 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:

  • Modic changes.
  • High intensity changes in the annulus.
  • Loss of disc height.
  • Decreased hydration of the disc.
  • Canal stenosis with or without spondylotic slip.
  • Gross facet joint changes requiring fusion for treatment.
  • Have documented annular pathology by other means. (e.g., with discography).
• 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.

Exclusion Criteria:

• 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.