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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01018771
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : April 5, 2017
Apatech, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Degenerative Disc Disease Procedure: Actifuse ABX Procedure: INFUSE, plus Mastergraft granules

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : July 2009
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Fusion, defined as evidence of bridging trabecular bone present at 1 year [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01018771

Moloney & Associates
Wollongong, Australia, NSW2522
Sponsors and Collaborators
Baxter Healthcare Corporation
Apatech, Inc.
Study Director: Huub Kruewel, Ph.D Director, Medical Affairs

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01018771     History of Changes
Other Study ID Numbers: CIP0803PLF
ACTRN12609000548235 ( Other Identifier: ANZCTR )
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

Keywords provided by Baxter Healthcare Corporation:
Degenerative disc disease
posterolateral lumbar fusion
bone substitute
bone graft
synthetic bone substitute
spinal surgery

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases