Total Knee Arthroplasty for GonarthrosisARTHROPROMANCT06907368
Analysis of the Functional Impact of Total Knee Arthroplasty Using Quantified Gait Analysis and Proprioceptive Evaluation
An observational study of Total Knee Arthroplasty for Gonarthrosis, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty for Gonarthrosis
- What is being tested?
- Quantitative Gait Analysis
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2025to 1 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who undergone total knee arthroplasty for gonarthrosis in Grenoble University Hospital
Who may be able to join
- Adult patient
- Gonarthrosis on imaging with indication for total knee arthroplasty (TKA)
- Isolated gonarthrosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Grenoble University Hospital
Grenoble, 38043
Benoît GAULIN, Dr, 04 76 76 28 69, BGaulin@chu-grenoble.fr
Estelle PALLUEL, PhD, 04 76 63 74 91, estelle.palluel@univ-grenoble-alpes.fr
About this study
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.
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
- Being tested
- Quantitative Gait Analysis
- Keywords
- Gonarthrosis, Proprioception, Functional recovery, Patient-reported Outcomes Measures (PROMs), Quantitative Gait Analysis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Gait AnalysisOther
Also called Functional tests, Proprioceptive tests, Questionnaires
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 .
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Preoperatively (PreOP) and 12 months postoperatively (PostOP12)
Secondary outcomes (9)
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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)
Evolution of Quality of Life
EQ5D-5L questionnaire
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee Arthroplasty for GonarthrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- University Grenoble Alps
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907368
- Sponsor's protocol ID
- 38RC24.0425
- Acronym
- ARTHROPROMA
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06907368
- Acronym / sponsor ID
- ARTHROPROMA / 38RC24.0425
- Conditions
- Total Knee Arthroplasty for Gonarthrosis
- Keywords
- Gonarthrosis, Proprioception, Functional recovery, Patient-reported Outcomes Measures (PROMs), Quantitative Gait Analysis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- University Grenoble Alps
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who undergone total knee arthroplasty for gonarthrosis in Grenoble University Hospital
Key inclusion criteria (3 listed)
- Adult patient
- Gonarthrosis on imaging with indication for total knee arthroplasty (TKA)
- Isolated gonarthrosis
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative Gait AnalysisAlso: Functional tests, Proprioceptive tests, QuestionnairesThe 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 . | Other | – |
Primary outcome
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)
The primary endpoint is a composite endpoint assessed by quantified gait analysis (QGA) : 1/ Gait speed 2 / Step length
9 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Total Knee Arthroplasty for Gonarthrosis
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
Not yet recruiting
Wearable Device Guided Exercise for Patients on Total Knee Arthroplasty Wait-list
Knee Osteoarthristis
Not yet recruiting
Robotic-Assisted Versus Conventional Total Knee Arthroplasty With Virtual Home-Based Rehabilitation
Osteoarthritis, Knee
Active, not recruitingObservational study
Evaluation of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty
Osteoarthritis, Knee, Arthritis, Rheumatoid
Not yet recruiting
A Randomized Comparison of the Efficacy of the IPACK Block Versus the Popliteal Plexus Block for Posterior Knee Analgesia, in Patients Undergoing a Total Knee Arthroplasty and Receiving a Continuous Distal Femoral Triangle Block
Osteoarthritis, Knee, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty for Gonarthrosis, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.