A Pivotal Study of rhBMP-2/ACS/INTER FIX™ Device for Posterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
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|ClinicalTrials.gov Identifier: NCT01491464|
Recruitment Status : Terminated
First Posted : December 14, 2011
Last Update Posted : August 2, 2013
Medtronic Spinal and Biologics
Information provided by (Responsible Party):
Medtronic Spinal and Biologics
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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 :
- Fusion [ Time Frame: 24 month ]
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 ]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 ]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 ]
- Disc Height Measurement [ Time Frame: 24 month ]
- General Health Status (SF-36) [ Time Frame: 24 month ]
- Pain Status (back pain, leg pain) [ Time Frame: 24 month ]
- Patient Satisfaction [ Time Frame: 24 month ]
- Patient Global Perceived Effect [ Time Frame: 24 month ]
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