Rehabilitation with Personalized Strategies According to Muscle Volume Before Knee Arthroplasty

Not Applicable

Terminated

• Conditions: Gonarthrosis; Arthroplasty
• Interventions: Other: Personalized rehabilitation program with electrostimulation; Other: Global rehabilitation program

• Registration Number: NCT04318197
• Lead Sponsor: University Hospital, Brest

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-03-20
• Study First Posted: 2020-03-23
• Study Start: 2020-12-18
• Primary Completion: 2022-12-27
• Study Completion: 2022-12-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Personalized rehabilitation	Personalized rehabilitation program with electrostimulation	2 hours of daily rehabilitation including at least 2 times 20 minutes of electrostimulation on atrophied muscles, 3 days per week during 4 weeks
Global rehabilitation	Global rehabilitation program	2 hours of daily rehabilitation, 3 days per week during 4 weeks

Primary Outcome Measures

Name	Time	Method
Difference of isometric strength D0-W4p	Day 0 to Week 4 postoperative	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.

Secondary Outcome Measures

Name	Time	Method
Time up and go test (TUG)	Day 0, Week 4, Week 4 postoperative, Week 12 postoperative	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.
Western Ontario McMaster Osteoarthritis Index (WOMAC)	Day 0, Week 4, Week 4 postoperative, Week 12 postoperative	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.
Difference of isometric strength D0-W12p	Day 0 to Week 12 postoperative	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.
Walking speed on 10 meters	Day 0, Week 4, Week 4 postoperative, Week 12 postoperative	The patient will be timed when walking 10meters on a graduated corridor. They will be allowed to stop or use a technical help.
Pain in Analogic Visual Scale (AVS)	Day 0, Week 4, Week 4 postoperative, Week 12 postoperative	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.
Muscles volumes	Day 0, Week 4, Week 2 postoperative	Quadriceps and hamstring volume as well as all muscles volume of each muscles groups will be evaluated in MRI.
Difference of isometric strength D0-W4	Day 0 to Week 4	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.

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France