Rehabilitation With Personalized Strategies According to Muscle Volume Before Knee Arthroplasty (REPERAGE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Arthroplasty; Gonarthrosis
• Intervention / Treatment: Other: Global rehabilitation program; Other: Personalized rehabilitation program with electrostimulation

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olivier REMY-NERIS, Pr; Phone Number: +33 02 98 22 33 73; Email: olivier.remy-neris@univ-brest.fr

Study Locations

• France
  • Brest, France, 29200
    • Recruiting
    • CHRU de Brest
    • Contact: Olivier REMY-NERIS, Pr; Phone Number: +33 02 98 22 33 73; Email: olivier.remy-neris@univ-brest.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Global rehabilitation; 2 hours of daily rehabilitation, 3 days per week during 4 weeks	Other: Global rehabilitation program; 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.
Experimental: Personalized rehabilitation; 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; 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.
No Intervention: Classic rehabilitation; 40 minutes of rehabilitation, once a week during 4 weeks.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Olivier REMY-NERIS, Pr, University Hospital of Brest

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2020
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: March 19, 2020
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (Actual): March 23, 2020

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 29BRC.19.0154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication.
• IPD Sharing Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion.
• IPD Sharing Access Criteria: Data access request will be reviewed by the internal committee of Brest University Hospital. Requestor will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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