No registrations found.
ID
Source
Brief title
Health condition
Patients operated for Total Disc Replacement (TDR)due to degenerative disc disease (DDD) in the lumbar spine.
Sponsors and support
Contact
E: wil.van.erk@mumc.nl
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Significant correlation of IS, AR and/or undersizing AUI with the occurrence of subsidence.
Comparing the clinical outcomes as reported in the questionnaires between patients with- or without subsidence.
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
Background summary
Through this study we want to look at the> 20-year survival and clinical follow up of patients who were operated for a disc prosthesis between 1989 and 2000. Primarily we look to the survival of the prosthesis secondary to the clinic and the functioning of patients in daily life.
Study objective
We hypothesize that implantation asymmetry (IS), angular rotation (AR) and undersizing (AUI) are predictors for the occurring of subsidence. Furthermore we believe subsidence is related to decreased clinical outcomes. Presumably Total Disc Replacement (TDR) facilitates residual motion and leads to less ADR.
Study design
n.a.
Intervention
Total Disc Replacement (TDR). TDR aims to reduce pain and restore and maintain motion of the spinal segment, thus reducing the risk of adjacent level degeneration that has been reported for fusion treatment .
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@orbisconcern.nl
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@orbisconcern.nl
Inclusion criteria
o All patients who underwent a TDR using a SB Charité III between 1989 and 2000
Exclusion criteria
o Deceased without a known TDR revision
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4468 |
| NTR-old | NTR5710 |
| Other | 16-N-22 : 16-N-22 |