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

NCT ID: NCT06907368

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2027-10-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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 .

Intervention Type: OTHER

Other Intervention Names

Functional tests; Proprioceptive tests; Questionnaires

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Grenoble Alps

OTHER

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Grenoble University Hospital

Grenoble, , France

Countries

France

Facility Contacts

Benoît GAULIN, Dr

Role: primary

BGaulin@chu-grenoble.fr

04 76 76 28 69

Estelle PALLUEL, PhD

Role: backup

estelle.palluel@univ-grenoble-alpes.fr

04 76 63 74 91

Other Identifiers

38RC24.0425

Identifier Type: -

Identifier Source: org_study_id