Pilot Study of rhBMP/BCP With or Without the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease
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|ClinicalTrials.gov Identifier: NCT01494441|
Recruitment Status : Completed
First Posted : December 19, 2011
Last Update Posted : August 2, 2013
Medtronic Spinal and Biologics
Information provided by (Responsible Party):
Medtronic Spinal and Biologics
The purpose of this pilot clinical trial is to evaluate both device designs (rhBMP-2/BCP and rhBMP-2/BCP/TSRH® spinal System) as methods of facilitating spinal fusion as compared to instrumented fusion with autograft in patients with symptomatic degenerative disc disease.
|Condition or disease||Intervention/treatment||Phase|
|Degenerative Disc Disease||Procedure: rhBMP-2/BCP Device: rhBMP-2/BCP/TSRH® Spinal System Device: Autograft/TSRH® Spinal System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Recombinant Human Bone Morphogenetic Protein-2 and Biphasic Calcium Phosphate With or Without the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Symptomatic Degenerative Disc Disease|
|Study Start Date :||May 1999|
|Actual Primary Completion Date :||March 2003|
|Actual Study Completion Date :||March 2003|
The rhBMP-2/BCP device component consists of recombinant human Bone Morphogenetic Protein-2 ( rhBMP-2) and the biphasic calcium phosphate (BCP) carrier.
|Experimental: rhBMP-2/BCP/TSRH® Spinal System||
Device: rhBMP-2/BCP/TSRH® Spinal System
rhBMP-2/BCP device will be used in conjunction with the posterior spinal fixation system, the TSRH® Spinal System.
|Active Comparator: Autograft/TSRH® Spinal System||
Device: Autograft/TSRH® Spinal System
The control device will be autogenous bone from the iliac crest of the patient used in conjunction with the TSRH® spinal System.
Other Name: Autograft
Primary Outcome Measures :
- Fusion [ Time Frame: 24 month ]
Fusion is defined as:
- Evidence of bridging trabecular bone.
- No evidence of motion as defined by: a. No more than 3mm difference in translation on the lateral flexion/extension radiographs 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 the lateral flexion/extension radiographs;
- Absence of radiolucent lines completely through the fusion mass.
- 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
Secondary Outcome Measures :
- Neurological Status Success [ Time Frame: 24 month ]Neurological status will be assessed preoperatively and postoperatively using a comprehensive neurological status scale. Neurological status is based on four types of measurements (sections): motor, sensory, reflexes and straight leg raise.
- Hip (Donor Site) Pain [ 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 ]
- Overall Success [ Time Frame: 24 month ]
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