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Long-term follow up disc replacements.

Long-term follow up of lumbar disc replacements and its adverse events. A retrospective study’

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26442
Enrollment
150
Registered
2016-02-02
Start date
2016-02-02
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients operated for Total Disc Replacement (TDR)due to degenerative disc disease (DDD) in the lumbar spine.

Interventions

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 tre

Sponsors

Prof. dr. L.W. van Rhijn, Head of the department of Orthoepdic surgery, University Medical Center Maastricht, Maastrich, the Netherlands Contact E: wil.van.erk@mumc.nl
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: o All patients who underwent a TDR using a SB Charité III between 1989 and 2000

Exclusion criteria

Exclusion criteria: o Deceased without a known TDR revision

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Contacts

Public ContactM.G.M. Schotanus

Department of Orthopedic Surgery, Orbis Medisch Centrum dr H vd Hoffplein 1

m.schotanus@orbisconcern.nl+31 (0)88 4597823

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)