ong-term follow up disc replacements.
Recruiting
- Conditions
- Patients operated for Total Disc Replacement (TDR)due to degenerative disc disease (DDD) in the lumbar spine.
- Registration Number
- NL-OMON26442
- Lead Sponsor
- Prof. dr. L.W. van Rhijn, Head of the department of Orthoepdic surgery, University Medical Center Maastricht, Maastrich, the NetherlandsContactE: wil.van.erk@mumc.nl
- Brief Summary
n.a.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
oAll patients who underwent a TDR using a SB Charité III between 1989 and 2000
Exclusion Criteria
oDeceased without a known TDR revision
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compare the long term clinical outcome concerning patient’s satisfaction, re-operation rate, disability rate and survival of the TDR to those reported in the literature for spinal fusion. <br>
- Secondary Outcome Measures
Name Time Method Significant correlation of IS, AR and/or undersizing AUI with the occurrence of subsidence.<br><br /><br /><br>Comparing the clinical outcomes as reported in the questionnaires between patients with- or without subsidence.<br><br /><br /><br>The degree of residual mobility and its possible correlation to the occurrence of ASD for which surgery was warranted. Furthermore to compare the ASD rate to those reported literature for spinal fusion<br>