Rate of Return to Sport After Total Knee Prosthesis: Comparison of Three Types of Prostheses (TKA&RTS)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Arthropathy
• Intervention / Treatment: Other: 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.

• Study Type: Observational
• Enrollment (Estimated): 660

Contacts and Locations

Study Locations

• France
  • Biarritz, France, 64200
    • Clinique Aguiléra
    • Contact: Jérôme MURGIER, MD; Phone Number: +33 5 36 28 64 00; Email: murgier.jerome@hotmail.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients are eligible on retrospective criteria. These are patients who underwent total knee prosthesis surgery between 2018 and 2020 with placement of a medial pivot, medial bearing and cruciate retaining type prosthesis.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
medial pivot; Return to sport rate for patients with a Medial Pivot knee prosthesis	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
medial bearing; Return to sport rate for patients with a Medial Bearing knee prosthesis	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
cruciate retaining; Return to sport rate for patients with a Cruciate Retaining prosthesis	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of return to sport	rate of return to sport after a minimum of 3 years after total knee prosthesis	3 years

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: June 23, 2023
• First Submitted That Met QC Criteria: June 23, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 2023-A00626-39

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