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Recruiting NCT05928403

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

Observational Knee Arthropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: total knee prosthesis.
Who it may be relevant to
Registry conditions: Knee Arthropathy. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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)

Overview

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.

Interventions

  • 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

Primary outcome measures

  • rate of return to sport [Time frame: 3 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 2 centers
  • Clinique Aguiléra — Biarritz
  • Clinique des Cèdres — Cornebarrieu

Identifiers

NCT: NCT05928403 · 2023-A00626-39

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗