A Pivotal Study of rhBMP-2/ACS/INTER FIX™ Device for Posterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease

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: NCT01491464
Recruitment Status : Terminated
First Posted : December 14, 2011
Last Update Posted : August 2, 2013
Information provided by (Responsible Party):
Medtronic Spinal and Biologics

Brief Summary:
The purpose of this clinical trial is to assess the safety and effectiveness of the rhBMP-2/ACS/INTER FIX™ device as compared to the autograft/INTER FIX™ device in patients with symptomatic degenerative disease.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Device: rhBMP-2/ACS/INTER FIX™ Device: Autogenous bone/INTER FIX™ Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Investigation of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With the INTER FIX™ Device for Posterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
Study Start Date : March 1999
Actual Primary Completion Date : September 2002
Actual Study Completion Date : September 2002

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: rhBMP-2/ACS Device: rhBMP-2/ACS/INTER FIX™
The INTER FIX™ device containing recombinant human Bone Morphogenetic Protein (rhBMP-2) soaked into an absorbable collagen sponge (ACS).
Other Name: recombinant human Bone Morphogenetic Protein-2

Active Comparator: Autogenous bone Device: Autogenous bone/INTER FIX™
The INTER FIX™ device containing autogenous bone taken from the patient's iliac crest.
Other Name: Autograft

Primary Outcome Measures :
  1. Fusion [ Time Frame: 24 month ]

    Fusion is defined as:

    1. Evidence of bridging trabeculae.
    2. No evidence of motion as defined by: a. No more than 3mm difference in translation on the lateral flexion/extension radiographs as determined by superimposing the two views, one upon the other. b. Less than 5° difference in angular motion between flexion and extension as seen on lateral flexion/extension radiographs.
    3. No evidence of radiolucency surrounding greater than 50% of either device.

  2. Pain/Disability Status [ Time Frame: 24 month ]
    The self-administered Oswestry Low Back Pain Disability Questionnaire will be used. Success for each individual patient will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score >= 15

  3. Neurological Status [ Time Frame: 24 month ]
    Neurological status will be assessed preoperatively and postoperatively using a comprehensive neurological status scale.

Secondary Outcome Measures :
  1. Hip (Donor Site) Pain [ Time Frame: 24 month ]
  2. Disc Height Measurement [ Time Frame: 24 month ]
  3. General Health Status (SF-36) [ Time Frame: 24 month ]
  4. Pain Status (back pain, leg pain) [ Time Frame: 24 month ]
  5. Patient Satisfaction [ Time Frame: 24 month ]
  6. Patient Global Perceived Effect [ Time Frame: 24 month ]

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

Inclusion Criteria:

  1. Has degenerative disc disease as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history (e.g., pain [leg, back, or symptoms in the sciatic nerve distribution], function deficit and/or neurological deficit) and radiographic studies (e.g., CT, MRI, X-Ray, etc.) to include one or more of the following:

    • instability (defined as angular motion >=5° and/or translation >= 4mm, based on Flex/Ext radiographs);
    • osteophyte formation;
    • decreased disc height;
    • thickening of ligamentous tissue;
    • disc degeneration or herniation; and/or
    • facet joint degeneration.
  2. Has preoperative Oswestry score >=35.
  3. Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW, 1932.).
  4. Has single-level symptomatic degenerative involvement from L2 to S1.
  5. Is at least 18 years of age, inclusive, at the time of surgery.
  6. Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of at least 6 months.
  7. If female of child-bearing potential, who is not pregnant or nursing, and who agrees to use adequate contraception for 16 weeks following surgery.
  8. Is willing and able to comply with the study plan and sign the Patient Informed Consent Form.

Exclusion Criteria:

  1. Had previous spinal fusion surgical procedure at the involved level.
  2. Has spinal instrumentation (which will not be removed) stabilizing the involved level.
  3. Has a condition which requires postoperative medications that interfere with fusion, such as steroids.
  4. Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
  5. Has presence of active malignancy.
  6. Has overt or active bacterial infection, either local or systemic.
  7. Is grossly obese, i.e., weight> 40% over ideal for their age and height.
  8. Has fever (temperature> 101°F oral) at the time of surgery.
  9. Has a documented titanium alloy allergy or intolerance.
  10. Is mentally incompetent. If questionable, obtain psychiatric consult.
  11. Has a Waddell Signs of Inorganic Behavior score of 3 or greater.
  12. Is a prisoner.
  13. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug usage.
  14. Is a tobacco user at the time of surgery.
  15. Has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., steroids or methotrexate).
  16. Has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
  17. Has a history of exposure to injectable collagen implants.
  18. Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
  19. Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following rhBMP-2/ACS implantation.
  20. Has received any previous exposure to any/all BMP of either human or animal extraction.
  21. Has a history of allergy to bovine products or a history of anaphylaxis.
  22. Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).

Responsible Party: Medtronic Spinal and Biologics Identifier: NCT01491464     History of Changes
Other Study ID Numbers: C-9806
First Posted: December 14, 2011    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: December 2011

Keywords provided by Medtronic Spinal and Biologics:
symptomatic degenerative disc disease

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