N/A
Completed N=186
Total Knee Arthroplasty With Vitamin E Polyethylene
Source: ClinicalTrials.gov NCT05810285 ↗Enrolled (actual)
186
Serious AEs
17.1%
Results posted
Dec 2024
Primary outcomePrimary: Implant Survival for Aseptic Loosening — 95.0; 97.8 percentage of survival implants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Implant Survival for Aseptic Loosening |
95.0; 97.8 | — |
| SECONDARY Implant Survival for Any Reason |
87.6; 89.6 | — |
| SECONDARY Forgotten Joint Score (FJS-12) |
59; 56 | — |
| SECONDARY American Knee Society Score (KSS) |
84; 80; 77; 63 | — |
| SECONDARY Periprosthetic Radiolucent Line |
28; 10 | — |
| SECONDARY Periprosthetic Osteolysis |
1; 1 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05810285). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.