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

Knee Arthropathy Clinical Trial

— TKA&RTS  

Official title:

Rate of Return to Sport After Total Knee Prosthesis: Comparison of Three Different Types of Prostheses (Medial Pivot, Medial Bearing and Cruciate Retaining)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05928403
• Other study ID #: 2023-A00626-39
• Status: Recruiting
• Start date: June 11, 2024
• Est. completion date: June 2025

Study information

• Verified date: June 2024
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 660
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Knee Arthropathy

Intervention

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

Locations

Country	Name	City	State
France	Clinique Aguiléra	Biarritz
France	Clinique des Cèdres	Cornebarrieu

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of return to sport	rate of return to sport after a minimum of 3 years after total knee prosthesis	3 years