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NCT Number: NCT05928403

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

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Aguiléra, Biarritz, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

total knee prosthesis

Other

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

Primary outcomes

  1. rate of return to sport

    Time frame: 3 years

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

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Collaborators

  • Euraxi Pharma

Registry information

Official study title

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

Acronym: TKA&RTS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2023
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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