Actifuse ABX Versus INFUSE in Posterolateral Instrumented Lumbar Fusion

Official Title: “A Prospective, Randomised Study Comparing the Use of Actifuse (Trademark) Advanced Bone Matrix (ABX) Synthetic Bone Substitute With INFUSE (Trademark) on Fusion in Patients Requiring Posterolateral Instrumented Lumbar Fusion”

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.

Intervention(s) in this Clinical Trial

• Procedure: Actifuse ABX
  • bone graft to be used in posterolateral instrumented lumbar fusion
• Procedure: INFUSE, plus Mastergraft granules
  • bone graft to be used in posterolateral instrumented lumbar fusion

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Actifuse ABX
  • Actifuse ABX bone substitute
• Active Comparator: INFUSE, plus Mastergraft granules

Primary Measures

• Fusion, defined as evidence of bridging trabecular bone present at 1 year
  • Time Frame: 1 year
    Safety Issue?: No

Secondary Measures

• Improvement in the following clinical outcomes measurements: Pain/Disability as measured by Oswestry Lower Back Pain Questionnaire; Quality of Life as measured by Short Form Health Survey (SF36)and Neurological Status
  • Time Frame: 1 year
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Apatech, Inc. Industry

Overall Clinical Trial Officials and Contacts

Melanie Marshall Study Director Apatech, Inc.  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01018771

Study ID Number: CIP0803PLF

ClinicalTrials.gov Identifier: NCT01018771

Health Authority: Australia: Human Research Ethics Committee