Actifuse ABX Versus INFUSE in Posterolateral Instrumented Lumbar Fusion

Not Applicable

Completed

• Conditions: Degenerative Disc Disease
• Interventions: Procedure: Actifuse ABX; Procedure: INFUSE, plus Mastergraft granules

• Registration Number: NCT01018771
• Lead Sponsor: Baxter Healthcare Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-11-24
• Study First Submitted QC: 2009-11-24
• Study First Posted: 2009-11-25
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Actifuse ABX	Actifuse ABX	Actifuse ABX bone substitute
INFUSE, plus Mastergraft granules	INFUSE, plus Mastergraft granules	-

Primary Outcome Measures

Name	Time	Method
Fusion, defined as evidence of bridging trabecular bone present at 1 year	1 year

Secondary Outcome Measures

Name	Time	Method
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	1 year

Trial Locations

Locations (1)

Moloney & Associates; 🇦🇺 Wollongong, Australia