No registrations found.
ID
Source
Health condition
Hip, Arthroplasty , Radio Stereometric Analysis, Aseptic loosening, Migration, Clinical introduction, Acetabular component
Sponsors and support
Intervention
Outcome measures
Primary outcome
RSA studies:
Migration expressed in proximal migration or increase in inclination in the first 2 post-operative year in mm.
Secondary outcome
Survival / cohort studies:
Percentage revision or intended revision for aseptic loosening of the acetabular component at 5 year intervals (e.g. 5 year; 10 year; 15 year et cetera).
Background summary
This meta-analysis combines early migration from RSA studies with long term revision rates from survival studies for aseptic loosening of the acetabular 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 Swedisch 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 tressholds (in mm) for the categories: acceptable, at risk and unacceptable.
Study objective
The aim of the meta-analysis is to investigate the early predictive value of migration measured by RSA 2 years post-operatively for revision for aseptic loosening of the acetabular component in THA 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 acetabular components in primary total hip arthroplasty (THA).
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 Hip replacement;
2. Minimal RSA follow-up of 1 year, measuring acetabular 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 acetabular 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).
Exclusion criteria
RSA studies:
1. Non-clinical studies: Animal, experimental set up, phantom.
Survival / cohort studies:
1. Less than 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 | NL2980 |
| NTR-old | NTR3128 |
| Other | UTN : U1111-1112-9514 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |