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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Total Knee Arthroplasty for Gonarthrosis
• Intervention / Treatment: Other: Quantitative Gait Analysis

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • Grenoble University Hospital
    • Contact: Benoît GAULIN, Dr; Phone Number: 04 76 76 28 69; Email: BGaulin@chu-grenoble.fr
    • Contact: Estelle PALLUEL, PhD; Phone Number: 04 76 63 74 91; Email: estelle.palluel@univ-grenoble-alpes.fr
    • Principal Investigator: Benoît GAULIN, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional recovery by analyzing changes in gait variability	Functional recovery is assessed by quantified gait analysis (QGA) : Measurement of step length Measurement of step width Measurement of cycle time Measurement of step speed and cadence Measurement of gait variability and stability parameters	Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)
Impact of total knee arthroplasty (TKA) on proprioception	Proprioception is assessed by Joint Position Sense (JPS) test : Error between target angle and established angle: average absolute error in relation to the target angle in degrees. This will enable us to obtain an average absolute error for the three trials for each target angle per lower limb and per patient.	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	Measurement of displacements of the center of pressure and gravity, angular velocities (trunk, knee, hip, ankle), hip and knee angular moments, ground reaction force (for each lower limb).	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	Analysis of ground reaction force on healthy side vs. pathological side during ascent and descent of step, knee joint amplitudes in flexion during ascent and descent of step.	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	Analysis of obstacle-crossing accuracy (minimum foot-to-obstacle distance and distance covered by the lower limb, taking the center of the ankle as reference, until the obstacle is crossed).; Analysis of variability: Variability in the position of the center of the ankle when passing the obstacle + variability in the trajectory of the lower limb (hip and knee angles + angular velocity of the hip and knee).; Analysis of movement symmetry: Symmetry between the legs, based on the vertical distance foot-obstacle during clearance, and on the similarity index based on angles and angular velocity of the hip, knee and trunk.	Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)
Evolution of Quality of Life	EQ5D-5L questionnaire	Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)
Evolution of the patient's functional results assessed by the KSS questionnaire	The KSS is a functional questionnaire (e.g. questions on pain, joint amplitude, possible walking distance) completed by the patient and the surgeon.	Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)
Evolution of the patient's functional results assessed by the SKV questionnaire	The SKV score is a very simple functional score, based on a single question: "How would you rate your knee on the day of the examination, compared with a normal knee in percentage terms?" completed by the patient.	Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)
Evolution of the patient's functional results assessed by the KOOS questionnaire	KOOS is a questionnaire assessing knee function, pain and impact on daily life score to be completed exclusively by the patient. The questionnaire comprises five dimensions: symptoms, stiffness, pain, function of daily life and activities, sports and leisure.	Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: University Grenoble Alps

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Gonarthrosis; Proprioception; Functional recovery; Patient-reported Outcomes Measures (PROMs); Quantitative Gait Analysis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 38RC24.0425

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No