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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Apatech, Inc.
ClinicalTrials.gov Identifier:
NCT01013389
First received: November 10, 2009
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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 Intervention
Degenerative Disc Disease
Procedure: Actifuse ABX
Procedure: INFUSE, plus master granules (MGG)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Further study details as provided by Apatech, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: June 2007
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013389

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

No publications provided

Responsible Party: Apatech, Inc.
ClinicalTrials.gov Identifier: NCT01013389     History of Changes
Other Study ID Numbers: CIP0702PLF, ACTRN12609000527268, EudraCT Number: 2009-012672-27
Study First Received: November 10, 2009
Last Updated: November 12, 2013
Health Authority: Australia: Human Research Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Apatech, Inc.:
actifuse
INFUSE
InductOs
DDD
degenerative disk disease
PLIF
PITF
PLF
poterolateral lumber fusion
Bone substitute
bone graft
synthetic bone substitute

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

ClinicalTrials.gov processed this record on August 21, 2014