Clinical Study of rhBMP-2/BCP With the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease
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|ClinicalTrials.gov Identifier: NCT01494454|
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
This study is designed to assess the safety and effectiveness of the rhBMP/BCP/TRSH Spinal System in treatment of the patients with degenerative disc disease.
|Condition or disease||Intervention/treatment||Phase|
|Degenerative Disc Disease||Device: rhBMP-2/BCP/TSRH® or rhBMP-2/BCP/CD HORIZON® Spinal System Device: Autograft/TSRH® or autograft/CD HORIZON® Spinal System.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||197 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Study of Recombinant Human Bone Morphogenetic Protein-2 and Biphasic Calcium Phosphate With Either the TSRH® Spinal System or the CD Horizon® Spinal System for Posterolateral Lumbar Fusion in Patients With DDD|
|Study Start Date :||August 1999|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||November 2007|
Device: rhBMP-2/BCP/TSRH® or rhBMP-2/BCP/CD HORIZON® Spinal System
rhBMP-2/BCP device will be used in conjunction with the posterior spinal fixation system, either the TSRH® Spinal System or CD HORIZON® Spinal System.
Other Name: Recombinant human bone morphogenetic protein
|Active Comparator: Autograft||
Device: Autograft/TSRH® or autograft/CD HORIZON® Spinal System.
Either the TSRH® Spinal System or the CD HORIZON® Spinal System with autogenous bone taken from the patient's iliac crest.
Other Name: Autogenous bone graft
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 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 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 [ 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 ]
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