actifuse abx versus infuse in posterolateral instrumented lumbar fusion

Conditions: Degenerative Disc Disease

Summary: this is a prospective randomised study. primary objective: evaluation of success rates of actifuse abx and infuse in achieving bone fusion. secondary objectives: assess clinical outcome measurements.


Eligibility criteria:
inclusion criteria: * have 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). * have a preoperative oswestry back disability score of 30 or more. * aged 18 to 75 years and skeletally mature at time of surgery. * have 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 will 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 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. * who, in the opinion of the principal investigator or co-investigators, is 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.

Keywords: actifuse infuse inductos ddd degenerative disc disease plf posterolateral lumbar fusion bone substitute bone graft synthetic bone substitute spinal surgery