Total Knee Arthroplasty With Vitamin E Polyethylene

February 22, 2024 updated by: Permedica spa
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Verbania
      • Omegna, Verbania, Italy, 28887
        • Ospedale Centro Ortopedico di Quadrante

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients 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

Description

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 5-year follow-up;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
VITAMIN E
Patients who received cemented total knee arthroplasty with vitamin E blended polyethylene mobile bearing
Device: GKS Prime Flex Mobile knee
Total knee arthroplasty with a cemented mobile bearing bicompartmental knee prosthesis
POLYETHYLENE
Patients who received cemented total knee arthroplasty with conventional polyethylene mobile bearing
Device: GKS Prime Flex Mobile knee
Total knee arthroplasty with a cemented mobile bearing bicompartmental knee prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant survival for any reason
Time Frame: Minimum follow-up of 5 years
Kaplan-Meier cumulative survival with revision due to any reason as the end-point
Minimum follow-up of 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant survival for aseptic loosening
Time Frame: Minimum follow-up of 5 years
Kaplan-Meier cumulative survival with revision due to aseptic loosening as the end-point
Minimum follow-up of 5 years
Periprosthetic radiolucent line
Time Frame: Minimum follow-up of 5 years
Radiographic sign of bone remodelling around the implant
Minimum follow-up of 5 years
Periprosthetic osteolysis
Time Frame: Minimum follow-up of 5 years
Radiographic sign of focal bone resorption around the implant
Minimum follow-up of 5 years
Forgotten Joint Score (FJS-12)
Time Frame: Minimum follow-up of 5 years
Patient related outcome measurement scored from 0 to 100 (higher scores mean better outcomes)
Minimum follow-up of 5 years
American Knee Society Score (KSS)
Time Frame: Minimum follow-up of 5 years
Clinical and Functional knee score. Both sections are scored from 0 to 100 (higher scores mean better outcomes)
Minimum follow-up of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Permedica spa

Investigators

  • Principal Investigator: Marco Spezia, MD, Ospedale Centro Ortopedico di Quadrante

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2021

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

March 28, 2023

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Estimated)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VITALECOQ2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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