Actifuse ABX Versus INFUSE in Posterolateral Instrumented Lumbar Fusion (PLIF) With Interbody Fusion (APPRAISET1)

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. Identifier: NCT01013389
Recruitment Status : Completed
First Posted : November 13, 2009
Last Update Posted : April 5, 2017
Apatech, Inc.
Information provided by (Responsible Party):
Baxter Healthcare Corporation

Brief Summary:

The primary objective of this clinical trial is to evaluate the success rates of Actifuse ABX and INFUSE in achieving bone fusion.

The secondary objective of this clinical trial is to assess clinical outcome measurements.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Procedure: Actifuse ABX Procedure: INFUSE, plus master granules (MGG) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 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)ABX Synthetic Bone Substitute With INFUSE (Registrered Trademark) in Patients Requiring Posterolateral Instrumented Lumbar Fusion With Interbody Fusion
Study Start Date : June 2007
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Actifuse ABX
Actifuse ABX bone substitute
Procedure: Actifuse ABX
bone substitute used for posterolateral instrumented lumbar fusion with interbody fusion

Active Comparator: INFUSE, plus master granules (MGG)
synthetic bone substitute used in posterolateral instrumented lumber fusion with interbody fusion
Procedure: INFUSE, plus master granules (MGG)
bone substitute in posterolateral instrumented lumbar fusion with interbody fusion

Primary Outcome Measures :
  1. Fusion, defined as evidence of bridging trabecular bone present at 1 year as assessed by CT scan as well as a determination of no motion as assessed by plain radiographs. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Improvement clinical outcomes measurements compared to pre-opscores: 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Has 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).
  • Has a preoperative Oswestry Back Disability Score of 30 or more.
  • Aged 18 to 75 years and skeletally mature at time of surgery.
  • Has 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 willing 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 general 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.
  • Is, in the opinion of the Principal Investigator or Co-Investigators, 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 identifier (NCT number): NCT01013389

Moloney & Associates
Wollongong, Australia, NSW 2500
Isala Klinik
Zwolle, Netherlands, 8011 JW
Sponsors and Collaborators
Baxter Healthcare Corporation
Apatech, Inc.
Study Director: Huub Kreuwel, Ph.D Director, Medical Affairs

Responsible Party: Baxter Healthcare Corporation Identifier: NCT01013389     History of Changes
Other Study ID Numbers: CIP0702PLF
EudraCT Number: 2009-012672-27
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

Keywords provided by Baxter Healthcare Corporation:
degenerative disk disease
poterolateral lumber fusion
Bone substitute
bone graft
synthetic bone substitute

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