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

Sponsor
University Hospital, Brest (Other)
Overall Status
Recruiting
CT.gov ID
NCT04318197
Collaborator
(none)
48
1
3
39.4
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Personalized rehabilitation program with electrostimulation
  • Other: Global rehabilitation program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Personalized Rehabilitation Strategies According to Muscle Volume Before Knee Arthroplasty: a Pilot Study
Actual Study Start Date :
Dec 18, 2020
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHRU de Brest Brest France 29200

Sponsors and Collaborators

  • University Hospital, Brest

Investigators

  • Principal Investigator: Olivier REMY-NERIS, Pr, University hospital of Brest

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT04318197
Other Study ID Numbers:
  • 29BRC.19.0154
First Posted:
Mar 23, 2020
Last Update Posted:
May 17, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2022