No registrations found.
ID
Source
Health condition
knee, arthroplasty, tibial component, aseptic loosening, migration, clinical introduction, Radiostereometric analysis (RSA)
Sponsors and support
Intervention
Outcome measures
Primary outcome
RSA studies:
Migration expressed in Maximal Total Point Motion (MTPM) at 1 year in mm.
Survival / cohort studies:
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).
Secondary outcome
N/A
Background summary
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.
Study objective
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.
Study design
N/A
Intervention
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).
B.G.C.W. Pijls
Leiden 2300 RC
The Netherlands
+31 (0)71 5261566
b.g.c.w.pijls@lumc.nl
B.G.C.W. Pijls
Leiden 2300 RC
The Netherlands
+31 (0)71 5261566
b.g.c.w.pijls@lumc.nl
Inclusion criteria
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).
Exclusion criteria
RSA studies:
1. Non-clinical studies: Animal, experimental set up, phantom.
Survival / cohort studies:
1. Minimal 75 arthroplasties at baseline.
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 | NL2311 |
| NTR-old | NTR2417 |
| Other | UTN : U1111-1112-9513 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |