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

NCT06907368 | Not Yet Recruiting

• 1 other identifier: 38RC24.0425
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Total Knee Arthroplasty for Gonarthrosis

Keywords

Gonarthrosis; Proprioception; Functional recovery; Patient-reported Outcomes Measures (PROMs); Quantitative Gait Analysis

Outcome Measures

Primary Outcomes (1)

• Post-operative functional recovery of patients who have undergone total knee arthroplasty for gonarthrosis by analyzing their locomotion ability

  The primary endpoint is a composite endpoint assessed by quantified gait analysis (QGA) : 1/ Gait speed 2 / Step length

  Preoperatively (PreOP) and 12 months postoperatively (PostOP12)

Secondary Outcomes (9)

• Functional recovery by analyzing changes in gait variability

  Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)

• Impact of total knee arthroplasty (TKA) on proprioception

  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

  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

  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

  Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)

Interventions

Quantitative Gait Analysis OTHER

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 .

Also known as: Functional tests, Proprioceptive tests, Questionnaires

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who undergone total knee arthroplasty for gonarthrosis in Grenoble University Hospital

You may qualify if:

• Adult patient
• Gonarthrosis on imaging with indication for total knee arthroplasty (TKA)
• Isolated gonarthrosis

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• University Grenoble Alps: collaborator

Study Sites (1)

Grenoble University Hospital

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

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

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

FR (1)