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OpenTrials
Completed

NCT Number: NCT05810285

Total Knee Arthroplasty With Vitamin E Polyethylene

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

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Key information

Conditions

Knee Osteoarthritis Arthritis Bone Diseases Bone Resorption Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Osteolysis Rheumatic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Centro Ortopedico di Quadrante

Omegna, Verbania, 28887, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GKS Prime Flex Mobile knee

Device

Total knee arthroplasty with a cemented mobile bearing bicompartmental knee prosthesis

Primary outcomes

  1. Implant Survival for Aseptic Loosening

    Time frame: 10-year follow-up

    Kaplan-Meier cumulative survival with revision due to aseptic loosening as the end-point

Secondary outcomes

  1. Implant Survival for Any Reason

    Time frame: 10-year follow-up

    Kaplan-Meier cumulative survival with revision due to any reason as the end-point

  2. Forgotten Joint Score (FJS-12)

    Time frame: At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively

    Patient related outcome measurement scored from 0 to 100 (higher scores mean better outcomes)

  3. American Knee Society Score (KSS)

    Time frame: At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively

    Clinical and Functional scores of the knee. Both scores are scored from 0 to 100 (higher scores mean better outcomes)

  4. Periprosthetic Radiolucent Line

    Time frame: At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively

    Radiographic sign of bone remodelling around the implant

  5. Periprosthetic Osteolysis

    Time frame: At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively

    Radiographic sign of focal bone resorption around the implant

Sponsors and collaborators

Lead sponsor

Permedica spa

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2023
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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