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Not yet recruiting NCT06907368

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

— Observational Total Knee Arthroplasty for Gonarthrosis

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: Quantitative Gait Analysis.
Who it may be relevant to
Registry conditions: Total Knee Arthroplasty for Gonarthrosis. Basic parameters: from 18 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 →

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Official title

Analysis of the Functional Impact of Total Knee Arthroplasty Using Quantified Gait Analysis and Proprioceptive Evaluation. Prospective, Single-center, Open-label Study, Cohort Follow-up.

Overview

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.

Interventions

  • Other 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

Primary outcome measures

  • Post-operative functional recovery of patients who have undergone total knee arthroplasty for gonarthrosis by analyzing their locomotion ability [Time frame: Preoperatively (PreOP) and 12 months postoperatively (PostOP12)]
Secondary outcome measures (9)
  • Functional recovery by analyzing changes in gait variability [Time frame: Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)]
  • Impact of total knee arthroplasty (TKA) on proprioception [Time frame: Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)]
  • Functional recovery after TKA by analyzing changes in daily living tasks by SIT TO STAND test [Time frame: Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)]
  • Functional recovery after TKA by analyzing changes in daily living tasks by STEP INITIATION test [Time frame: Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)]
  • Functional recovery after TKA by analyzing changes in daily living tasks by OBSTACLE CLEARANCE test [Time frame: Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)]
  • Evolution of Quality of Life [Time frame: Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)]
  • Evolution of the patient's functional results assessed by the KSS questionnaire [Time frame: Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)]
  • Evolution of the patient's functional results assessed by the SKV questionnaire [Time frame: Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)]
  • Evolution of the patient's functional results assessed by the KOOS questionnaire [Time frame: Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)]

Eligibility criteria

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

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 · 1 center
  • Grenoble University Hospital — Grenoble

Identifiers

NCT: NCT06907368 · 38RC24.0425

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗