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

Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05928403
Collaborator
(none)
660
1
12
54.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
660 participants
Observational Model:
Cohort
Time Perspective:
Other
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)
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. rate of return to sport [3 years]

    rate of return to sport after a minimum of 3 years after total knee prosthesis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinique Aguiléra Biarritz France 64200

Sponsors and Collaborators

  • GCS Ramsay Santé pour l'Enseignement et la Recherche

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GCS Ramsay Santé pour l'Enseignement et la Recherche
ClinicalTrials.gov Identifier:
NCT05928403
Other Study ID Numbers:
  • 2023-A00626-39
First Posted:
Jul 3, 2023
Last Update Posted:
Jul 3, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 3, 2023