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Long-term follow up disc replacements.


- candidate number23701
- NTR NumberNTR5710
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-feb-2016
- Secondary IDs16-N-22 16-N-22
- Public TitleLong-term follow up disc replacements.
- Scientific TitleLong-term follow up of lumbar disc replacements and its adverse events. A retrospective study’
- ACRONYMdiscus, spine, implants, Long-term FU TDR
- hypothesisWe 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.
- Healt Condition(s) or Problem(s) studiedDiscectomy, Lumbar disk
- Inclusion criteriao All patients who underwent a TDR using a SB Charité III between 1989 and 2000
- Exclusion criteriao Deceased without a known TDR revision
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 2-feb-2016
- planned closingdate30-aug-2016
- Target number of participants150
- InterventionsTotal 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 .
- Primary outcomeCompare 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 outcomeSignificant 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
- Timepointsn.a.
- Trial web siten.a.
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. M.G.M. Schotanus
- CONTACT for SCIENTIFIC QUERIES Joep Kitzen
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- Publicationsn.a.
- Brief summaryThrough 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.
- Main changes (audit trail)
- RECORD2-feb-2016 - 25-apr-2016


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