Rehabilitation With Personalized Strategies According to Muscle Volume Before Knee Arthroplasty

Study Overview
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Brief Summary
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Preoperative rehabilitation before total knee arthroplasty (TKA) has not been proven to be effective. Latest meta-analyzes do not find any improvement of motor performance during gait 6 months after surgery. However, most of the previous studies did not specifically target muscle atrophy to design rehabilitation protocol. Pre-operative muscle atrophy, although not systematic, is often observed. The preoperative muscles volumes of thigh muscles have been poorly identified and never used to adjust the pre operative rehabilitation strategy. As part of the FOLLOWKNEE (RHU) project, which attempts to implement a personalized management of TKA and its follow-up, this study wants to explore the potential effect of adapted treatment to improve muscle force and muscle volume before TKA.

Official Title
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Personalized Rehabilitation Strategies According to Muscle Volume Before Knee Arthroplasty: a Pilot Study

Conditions
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Gonarthrosis, Arthroplasty

Intervention / Treatment
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* Other: Personalized rehabilitation program with electrostimulation
* Other: Global rehabilitation program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Terminal stage gonarthrosis with total knee arthroplasty (TKA) indication TKA indicated by the surgeon Body Mass Index < 35 Acceptance to realize a preoperative rehabilitation in outpatient setting Adult between 18 and 80 years old Patient affiliated to social security Patient who signed an informed consent Exclusion Criteria: Functionally uncomfortable osteoarticular illness (disabling pain, functional limitation of joint amplitudes or muscle strength) of controlateral leg. Unable or refusal to consent Contraindication to electrostimulation (skin lesion, nearby implanted metallic material, implanted cardiac or neurologic electrostimulator, intolerance to muscle electrical stimulation) Unstable medical situation preventing the continuous realization of a program of at least 4 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Global rehabilitation<br>2 hours of daily rehabilitation, 3 days per week during 4 weeks | Other: Global rehabilitation program<br>* Patient with knee arthroplasty indication. After clinical assessment and a MRI measurement of muscle volume, patient start a 2 hours daily rehabilitation targeting muscles groups with strengthening and stretching exercises, 3 days per week during 4 weeks.<br>|
| Experimental: Personalized rehabilitation<br>2 hours of daily rehabilitation including at least 2 times 20 minutes of electrostimulation on atrophied muscles, 3 days per week during 4 weeks | Other: Personalized rehabilitation program with electrostimulation<br>* Patient with knee arthroplasty indication. After clinical assessment and a MRI measurement of muscle volume, patients start a 2 hours daily rehabilitation including 2 times 20 minutes of electrostimulation of atrophied muscles, 3 days per week during 4 weeks.<br>|
| No Intervention: Classic rehabilitation<br>40 minutes of rehabilitation, once a week during 4 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of isometric strength D0-W4p | Isometric strength of quadriceps (QS) and hamstring (HS) will be measured on isokinetic bench and the difference between D0 and W4 will be calculated as follows : (QSW4p-QSD0)+(HSW4p-HSD0). Personalized rehabilitation will first be compared to classic rehabilitation and if positive to global rehabilitation. | Day 0 to Week 4 postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of isometric strength D0-W4 | Isometric strength of quadriceps (QS) and hamstring (HS) will be measured on isokinetic bench and the difference between D0 and W4 (W4) will be calculated. | Day 0 to Week 4 | 
| Difference of isometric strength D0-W12p | Isometric strength of quadriceps (QS) and hamstring (HS) will be measured on isokinetic bench and the difference between D0 and W12postoperative (W12p) will be calculated. | Day 0 to Week 12 postoperative | 
| Muscles volumes | Quadriceps and hamstring volume as well as all muscles volume of each muscles groups will be evaluated in MRI. | Day 0, Week 4, Week 2 postoperative | 
| Walking speed on 10 meters | The patient will be timed when walking 10meters on a graduated corridor. They will be allowed to stop or use a technical help. | Day 0, Week 4, Week 4 postoperative, Week 12 postoperative | 
| Time up and go test (TUG) | The patient must get up from the sitting position and walk three meters from the chair and then retrace his steps (turn 180 degrees) and sit down again. The time that the person puts to this activity is timed by the evaluator. | Day 0, Week 4, Week 4 postoperative, Week 12 postoperative | 
| Western Ontario McMaster Osteoarthritis Index (WOMAC) | WOMAC is a medical scale for hip and osteoarthritic knee consisting of 24 questions scored between 0 and 4. The questions are about pain, joint stiffness and function. | Day 0, Week 4, Week 4 postoperative, Week 12 postoperative | 
| Pain in Analogic Visual Scale (AVS) | The pain during the 5 last days will be evaluated by Analogic Visual Scale. Pain is evaluated on a scale between 0 and 10. 0 is no pain and 10 the worse pain. | Day 0, Week 4, Week 4 postoperative, Week 12 postoperative |