CompletedNot Applicable

Total Knee Arthroplasty With Vitamin E Polyethylene

Italy186 participantsStarted 2022-04-12

Plain-language summary

The aim of this observational study is to investigate if there is any difference in survival rate, clinical and radiological results after total knee replacement with vitamin E-blended polyethylene in comparison to conventional polyethylene at minimum 7-year follow-up

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient who received primary cemented total knee arthroplasty with GKS Prime Flex Mobile knee by Permedica Orthopaedics with vitamin E polyethylene bearing or with conventional polyethylene bearing. * Minimum 7-year follow-up; * Age ≥ 18 and \< 85 years; * Patient who signed informed consent. Exclusion Criteria: * Patient who received primary cemented total knee arthroplasty with a different knee prosthetic design; * Patient already enrolled in other clinical studies.

What they're measuring

Implant Survival for Aseptic Loosening

Timeframe: 10-year follow-up

Trial details

NCT IDNCT05810285

SponsorPermedica spa

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-06-27

Results submitted2024-07-25

View on ClinicalTrials.gov More Knee Osteoarthritis trials