Rehabilitation With Personalized Strategies According to Muscle Volume Before Knee Arthroplasty

Arthroplasty Clinical Trial

— REPERAGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04318197
• Other study ID #: 29BRC.19.0154
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2020
• Est. completion date: April 2024

Study information

• Verified date: May 2022
• Source: University Hospital, Brest
• Contact: Olivier REMY-NERIS, Pr
• Phone: 02 98 22 33 73
• Email: olivier.remy-neris[@]univ-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: April 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty
• Gonarthrosis
• Osteoarthritis, Knee

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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