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Starting soon Observational

Analysis of the Functional Impact of Total Knee Arthroplasty Using Quantified Gait Analysis and Proprioceptive Evaluation

NCT06907368 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-04-01
Last updated
2025-04-02

Condition(s) studied

Total Knee Arthroplasty for Gonarthrosis

Investigational drug(s) / intervention(s)

Quantitative Gait Analysis

Quantitative Gait Analysis: The following explorations will be carried out pre-operatively (pre-OP), then post-operatively at 3 months (post-OP3) and 12 months (post-OP12) : * Quantified gait analysis (QGA) * Functional tests (mechanical analysis of everyday tasks): * SIT-TO-STAND test (test consisting of standing up and sitting down on a chair) * STEP INITIATION test (test consisting of walking up a step and then down) * Proprioceptive tests : * Joint Position Sense (JPS) (angle memorization and reproduction test at the knee joint) * OBSTACLE CLEARANCE test (test consisting in simulating the clearance of an obstacle) * Questionnaires : * Functional questionnaires : * KSS (Knee Society Score) * SKV (Simple knee value) * KOOS (Knee Injury and Osteoarthritis Outcome Score) * Quality of life (EQ5D-5L) The total duration of each exploration session is estimated at 1 hour .

Study summary

Total knee arthroplasty remains the gold standard in the management of disabling gonarthrosis. Improved functional results, increased availability of care and an ageing population have all contributed to the rise in total knee replacement surgery in Western countries. Surgical techniques have been steadily improving for several decades in terms of implant positioning and joint alignment. However, 10% of patients are dissatisfied with the clinical and functional results. The challenge is to understand why these patients remain dissatisfied despite these surgical advances. Our aim is to understand the functional impact of knee prosthesis through a quantified analysis of gait, the performance of certain tasks of daily living, and pre- and post-operative proprioceptive assessments. We will link these results with patient feedback to identify factors potentially responsible for poor postoperative outcomes.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patient * Gonarthrosis on imaging with indication for total knee arthroplasty (TKA) * Isolated gonarthrosis Exclusion Criteria: * Patient objecting to study participation * Patient with an associated pathology causing balance and/or proprioceptive disorders (Parkinson's, stroke sequelae, etc.). * Patients with a history of cognitive disorders, either confirmed or currently being assessed. * IADL score below 3, indicating major dependence in daily life. * Patients unable to walk without technical aids for 6 months. * Patients unable to get up from a chair without armrests * Parker score below 6 * Protected persons covered by articles L1121-5 to L1121-8 of the French Public Health Code

Primary outcome measure(s)

  • Post-operative functional recovery of patients who have undergone total knee arthroplasty for gonarthrosis by analyzing their locomotion ability — Preoperatively (PreOP) and 12 months postoperatively (PostOP12)
    The primary endpoint is a composite endpoint assessed by quantified gait analysis (QGA) : 1/ Gait speed 2 / Step length

Trial sites (1)

FacilityCityRegionStatus
Grenoble University Hospital Grenoble France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06907368 on ClinicalTrials.gov ↗ ← All trials in France