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

G

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status

Enrolling

Conditions

Knee Arthropathy

Treatments

Other: total knee prosthesis

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT05928403
2023-A00626-39

Details and patient eligibility

About

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.

Full 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.

Enrollment

660 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

660 participants in 3 patient groups

medial pivot
Description:
Return to sport rate for patients with a Medial Pivot knee prosthesis
Treatment:
Other: total knee prosthesis
medial bearing
Description:
Return to sport rate for patients with a Medial Bearing knee prosthesis
Treatment:
Other: total knee prosthesis
cruciate retaining
Description:
Return to sport rate for patients with a Cruciate Retaining prosthesis
Treatment:
Other: total knee prosthesis

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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