Rate of Return to Sport After Total Knee Prosthesis: Comparison of Three Types of Prostheses

NCT ID: NCT05928403

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 660 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-11
• Study Completion Date: 2026-12-31

Brief Summary

The purpose of the study is the rate of return to sport (regardless of the sport envisaged) after a minimum of 3 years after total knee prosthesis.

Detailed Description

This is an ambispective, comparative study of three cohorts, non-randomized, open, monocentric, relating to the return to sport of patients who have benefited from one of the three designs of prostheses under study (medial pivot, medial bearing and cruciate retaining) after total knee prosthesis.

Patients who received a total knee prosthesis with medial pivot, medial bearing and cruciate retaining prosthesis between 2018 and 2020 will be called by the investigator, and the study will be offered to them (D-3 to D0). The investigator will explain the study to the patient, send him the information note electronically and answer all his questions about the study. If the patient agrees to participate after a reflection period, the inclusion (D0) will be documented in the medical file, and the patient will be assessed the same day by telephone using the assessments set up in the study, except for the questionnaires on his functional and physical abilities that will be sent to him electronically. The patient will return his answers to the questionnaires on this same email address or by telephone according to his preference. A secure and unique email address will be created by the principal investigator for the purposes of the study and for use strictly specific to the study, in the investigating center.

Conditions

Knee Arthropathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

medial pivot

Return to sport rate for patients with a Medial Pivot knee prosthesis

total knee prosthesis

Intervention Type: OTHER

Comparison of three cohorts on the return to sport of patients after total knee prosthesis according to the type of prosthesis

medial bearing

Return to sport rate for patients with a Medial Bearing knee prosthesis

total knee prosthesis

Intervention Type: OTHER

Comparison of three cohorts on the return to sport of patients after total knee prosthesis according to the type of prosthesis

cruciate retaining

Return to sport rate for patients with a Cruciate Retaining prosthesis

total knee prosthesis

Intervention Type: OTHER

Comparison of three cohorts on the return to sport of patients after total knee prosthesis according to the type of prosthesis

Interventions

total knee prosthesis

Comparison of three cohorts on the return to sport of patients after total knee prosthesis according to the type of prosthesis

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• First total knee prosthesis between 2018 and 2020;
• Conventional alignment technique using the same surgical technique for total knee prosthesis;
• Placement of a medial pivot prosthesis (Evolution®), mobile bearing (SCORE® Amplitude) or traditional cruciate retaining prosthesis (Stryker® Triathlon);
• Affiliation to a social security scheme;
• Patient having been informed and having given his oral non-objection

Exclusion Criteria

• Bilateral total knee prosthesis;
• Medical history of revision of Total Knee Prosthesis;
• Articulation malformation of the lower limbs;
• Having undergone revision surgery;
• Inability to understand information related to the study for linguistic, psychological, cognitive reasons;
• Patient under legal protection, or deprived of liberty by judicial or administrative decision.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Euraxi Pharma

INDUSTRY

Sponsor Role: collaborator

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique Aguiléra

Biarritz, , France

Site Status: NOT_YET_RECRUITING

Clinique des Cèdres

Cornebarrieu, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Jérôme MURGIER, MD

Role: primary

murgier.jerome@hotmail.fr

5 36 28 64 00 ext. +33

Xavier CASSARD, MD

Role: primary

dr.cassard@orange.fr

562133284 ext. +33

Other Identifiers

2023-A00626-39

Identifier Type: -

Identifier Source: org_study_id