A Pivotal Study of rhBMP-2/ACS/INTER FIX™ Device for Posterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
This study has been terminated.
Information provided by (Responsible Party):
Medtronic Spinal and Biologics
First received: December 12, 2011
Last updated: August 1, 2013
Last verified: December 2011
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.
Degenerative Disc Disease
Device: rhBMP-2/ACS/INTER FIX™
Device: Autogenous bone/INTER FIX™
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Fusion [ Time Frame: 24 month ] [ Designated as safety issue: No ]
Fusion is defined as:
- Evidence of bridging trabeculae.
- 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.
- No evidence of radiolucency surrounding greater than 50% of either device.
- Pain/Disability Status [ Time Frame: 24 month ] [ Designated as safety issue: No ]
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
- Neurological Status [ Time Frame: 24 month ] [ Designated as safety issue: No ]
Neurological status will be assessed preoperatively and postoperatively using a comprehensive neurological status scale.
Secondary Outcome Measures:
- Hip (Donor Site) Pain [ Time Frame: 24 month ] [ Designated as safety issue: No ]
- Disc Height Measurement [ Time Frame: 24 month ] [ Designated as safety issue: No ]
- General Health Status (SF-36) [ Time Frame: 24 month ] [ Designated as safety issue: No ]
- Pain Status (back pain, leg pain) [ Time Frame: 24 month ] [ Designated as safety issue: No ]
- Patient Satisfaction [ Time Frame: 24 month ] [ Designated as safety issue: No ]
- Patient Global Perceived Effect [ Time Frame: 24 month ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2002 (Final data collection date for primary outcome measure)
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
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- Has preoperative Oswestry score >=35.
- Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW, 1932.).
- Has single-level symptomatic degenerative involvement from L2 to S1.
- Is at least 18 years of age, inclusive, at the time of surgery.
- 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.
- If female of child-bearing potential, who is not pregnant or nursing, and who agrees to use adequate contraception for 16 weeks following surgery.
- Is willing and able to comply with the study plan and sign the Patient Informed Consent Form.
- Had previous spinal fusion surgical procedure at the involved level.
- Has spinal instrumentation (which will not be removed) stabilizing the involved level.
- Has a condition which requires postoperative medications that interfere with fusion, such as steroids.
- Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
- Has presence of active malignancy.
- Has overt or active bacterial infection, either local or systemic.
- Is grossly obese, i.e., weight> 40% over ideal for their age and height.
- Has fever (temperature> 101°F oral) at the time of surgery.
- Has a documented titanium alloy allergy or intolerance.
- Is mentally incompetent. If questionable, obtain psychiatric consult.
- Has a Waddell Signs of Inorganic Behavior score of 3 or greater.
- Is a prisoner.
- Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug usage.
- Is a tobacco user at the time of surgery.
- 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).
- Has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
- 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 within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following rhBMP-2/ACS implantation.
- Has received any previous exposure to any/all BMP of either human or animal extraction.
- Has a history of allergy to bovine products or a history of anaphylaxis.
- Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).
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||Medtronic Spinal and Biologics
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 12, 2011
||August 1, 2013
||United States: Food and Drug Administration
Keywords provided by Medtronic Spinal and Biologics:
symptomatic degenerative disc disease
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 22, 2014
Intervertebral Disc Degeneration