The aim of the meta-analysis is to investigate the early predictive value of migration measured by RSA 1 year post-operatively for revision for aseptic loosening of the femoral component in THA and to compose migration thresholds for safe and…
ID
Bron
Aandoening
Hip, Arthroplasty , Radio Stereometric Analysis, Aseptic loosening, Migration, Clinical introduction, Femoral component
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
RSA studies:<br>
Migration expressed in subsidence, retroversion or Maximal Total Point Motion (MTPM) in the first 2 post-operative years in mm.
<br><br>
Survival / cohort studies:<br>
Percentage revision or intended revision for aseptic loosening of the femoral component at 5 year intervals (e.g. 5 year; 10 year; 15 year et cetera).
Achtergrond van het onderzoek
This meta-analysis combines early migration from RSA studies with long term revision rates from survival studies for aseptic loosening of the femoral component. Included RSA studies will be matched to included survival studies according to prosthesis and fixation. Scatter-plots and meta-regression will be used in a sensitivity analysis to evaluate the effect of differences in patient demographics between studies as well as the effect of study quality.
According to the Swedish Hip Registry and Australian National Joint Replacement Registry the standard for revision will be set at 3% at 5 years and 5% at 10 years. These standards will be used to determine the migration thresholds (in mm) for the categories: acceptable, at risk and unacceptable.
Doel van het onderzoek
The aim of the meta-analysis is to investigate the early predictive value of migration measured by RSA 1 year post-operatively for revision for aseptic loosening of the femoral component in THA and to compose migration thresholds for safe and efficient clinical introduction of new designs.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
This is a systematic review and meta-analysis of migration studies (RSA) and survival / cohort studies (revisions for aseptic loosening) of the femoral components in primary total hip arthroplasty (THA).
Publiek
B.G.C.W. Pijls
Leiden 2300 RC
The Netherlands
+31 (0)71 5261566
b.g.c.w.pijls@lumc.nl
Wetenschappelijk
B.G.C.W. Pijls
Leiden 2300 RC
The Netherlands
+31 (0)71 5261566
b.g.c.w.pijls@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
RSA studies:
1. Primary Total Hip replacement;
2. Minimal RSA follow-up of 1 year, measuring femoral component migration.
Survival / cohort studies:
1. Primary Total Hip Replacement;
2. Follow up of 5, 10, 15, 20 or 25 years;
3. Endpoint aseptic loosening of femoral component:
A. For which revision surgery was undertaken;
B. For which revision surgery was indicated, but could not be undertaken (patient decline, poor general health).
4. Survival analysis or % revised due to aseptic loosening on total:
A. Available for specific prosthetic design and fixation;
B. At specific follow up (see point 2).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
RSA studies:
1. Non-clinical studies: Animal, experimental set up, phantom.
Survival / cohort studies:
1. Less than 75 arthroplasties at baseline.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2981 |
| NTR-old | NTR3129 |
| Ander register | UTN : U1111-1112-9515 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |