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Radiostereometric analysis as early predictor for aseptic loosening of the tibial component in total knee arthroplasty: A double meta-analysis.

Radiostereometric analysis as early predictor for aseptic loosening of the tibial component in total knee arthroplasty: A double meta-analysis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26815
Enrollment
Unknown
Registered
2010-07-19
Start date
2008-12-01
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

knee, arthroplasty, tibial component, aseptic loosening, migration, clinical introduction, Radiostereometric analysis (RSA)

Interventions

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

Sponsors

Leiden University Medical Center (LUMC); Department of Orthopaedics
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: RSA studies: 1. Non-clinical studies: Animal, experimental set up, phantom. Survival / cohort studies: 1. Minimal 75 arthroplasties at baseline.

Design outcomes

Primary

MeasureTime frame
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).—

Contacts

Public ContactB.G.C.W. Pijls

Postbus 9600, Postzone J-11-S

b.g.c.w.pijls@lumc.nl+31 (0)71 5261566

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)