The aim of the meta-analysis is to further investigate the early predictive value of migration measured by RSA 1 year post-operatively for revision for aseptic loosening in TKA and to compose migration thresholds for safe and efficient clinical…
ID
Bron
Aandoening
knee, arthroplasty, tibial component, aseptic loosening, migration, clinical introduction, Radiostereometric analysis (RSA)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
RSA studies:<br>
Migration expressed in Maximal Total Point Motion (MTPM) at 1 year in mm.
<br><br>
Survival / cohort studies:<br>
Percentage revision or intended revision for aseptic loosening of the tibial 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 tibial component.
Included RSA studies will be matched to included survival studies according to prosthesis, fixation and insert. 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 Swedisch Knee 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 tressholds (in mm) for the categories: acceptable, at risk and unacceptable.
Doel van het onderzoek
The aim of the meta-analysis is to further investigate the early predictive value of migration measured by RSA 1 year post-operatively for revision for aseptic loosening in TKA 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 tibial component in primary total knee arthroplasty (TKA).
Algemeen / deelnemers
B.G.C.W. Pijls
Leiden 2300 RC
The Netherlands
+31 (0)71 5261566
b.g.c.w.pijls@lumc.nl
Wetenschappers
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 Knee replacement;
2. Minimal RSA follow-up of 1 year, measuring prosthesis micromotion.
Survival / cohort studies:
1. Primary Total Knee Replacement;
2. Follow up of 5, 10, 15, 20 or 25 years;
3. Endpoint aseptic loosening of tibial:
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. Minimal 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 | NL2311 |
| NTR-old | NTR2417 |
| Ander register | UTN : U1111-1112-9513 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |