Actifuse ABX Versus INFUSE in Posterolateral Instrumented Lumbar Fusion (APPRAISET2)

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Procedure: Actifuse ABX; Procedure: INFUSE, plus Mastergraft granules

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Wollongong, Australia, NSW2522
    • Moloney & Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Actifuse ABX; Actifuse ABX bone substitute	Procedure: Actifuse ABX; bone graft to be used in posterolateral instrumented lumbar fusion
Active Comparator: INFUSE, plus Mastergraft granules	Procedure: INFUSE, plus Mastergraft granules; bone graft to be used in posterolateral instrumented lumbar fusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fusion, defined as evidence of bridging trabecular bone present at 1 year	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Collaborators: Apatech, Inc.
• Investigators: Study Director: Huub Kruewel, Ph.D, Director, Medical Affairs

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: November 24, 2009
• First Submitted That Met QC Criteria: November 24, 2009
• First Posted (Estimate): November 25, 2009

Study Record Updates

• Last Update Posted (Actual): April 5, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: actifuse; INFUSE; InductOs; DDD; Degenerative disc disease; PLF; posterolateral lumbar fusion; bone substitute; bone graft; synthetic bone substitute; spinal surgery
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: CIP0803PLF; ACTRN12609000548235 (Other Identifier: ANZCTR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No