NCT05928403

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
660

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Jun 2024

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jun 2024Dec 2026

First Submitted

Initial submission to the registry

June 23, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

June 11, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

2.5 years

First QC Date

June 23, 2023

Last Update Submit

January 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • rate of return to sport

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

    3 years

Study Arms (3)

medial pivot

Return to sport rate for patients with a Medial Pivot knee prosthesis

Other: total knee prosthesis

medial bearing

Return to sport rate for patients with a Medial Bearing knee prosthesis

Other: total knee prosthesis

cruciate retaining

Return to sport rate for patients with a Cruciate Retaining prosthesis

Other: total knee prosthesis

Interventions

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

cruciate retainingmedial bearingmedial pivot

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinique Aguiléra

Biarritz, 64200, France

NOT YET RECRUITING

Clinique des Cèdres

Cornebarrieu, 31700, France

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2023

First Posted

July 3, 2023

Study Start

June 11, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations