Back to resultsRehabilitation With Personalized Strategies According to Muscle Volume Before Knee Arthroplasty (REPERAGE)
Primary Purpose
Gonarthrosis, Arthroplasty
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Personalized rehabilitation program with electrostimulation
Global rehabilitation program
Sponsored by
About this trial
This is an interventional other trial for Gonarthrosis
Eligibility Criteria
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
Sites / Locations
- CHRU de BrestRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
No Intervention
Arm Label
Global rehabilitation
Personalized rehabilitation
Classic rehabilitation
Arm Description
2 hours of daily rehabilitation, 3 days per week during 4 weeks
2 hours of daily rehabilitation including at least 2 times 20 minutes of electrostimulation on atrophied muscles, 3 days per week during 4 weeks
40 minutes of rehabilitation, once a week during 4 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Muscles volumes
Quadriceps and hamstring volume as well as all muscles volume of each muscles groups will be evaluated in MRI.
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.
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.
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.
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.
Full Information
NCT ID
NCT04318197
First Posted
March 19, 2020
Last Updated
May 16, 2022
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT04318197
Brief Title
Rehabilitation With Personalized Strategies According to Muscle Volume Before Knee Arthroplasty
Acronym
REPERAGE
Official Title
Personalized Rehabilitation Strategies According to Muscle Volume Before Knee Arthroplasty: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 18, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gonarthrosis, Arthroplasty
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Global rehabilitation
Arm Type
Active Comparator
Arm Description
2 hours of daily rehabilitation, 3 days per week during 4 weeks
Arm Title
Personalized rehabilitation
Arm Type
Experimental
Arm Description
2 hours of daily rehabilitation including at least 2 times 20 minutes of electrostimulation on atrophied muscles, 3 days per week during 4 weeks
Arm Title
Classic rehabilitation
Arm Type
No Intervention
Arm Description
40 minutes of rehabilitation, once a week during 4 weeks.
Intervention Type
Other
Intervention Name(s)
Personalized rehabilitation program with electrostimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Global rehabilitation program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference of isometric strength D0-W4p
Description
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.
Time Frame
Day 0 to Week 4 postoperative
Secondary Outcome Measure Information:
Title
Difference of isometric strength D0-W4
Description
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.
Time Frame
Day 0 to Week 4
Title
Difference of isometric strength D0-W12p
Description
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.
Time Frame
Day 0 to Week 12 postoperative
Title
Muscles volumes
Description
Quadriceps and hamstring volume as well as all muscles volume of each muscles groups will be evaluated in MRI.
Time Frame
Day 0, Week 4, Week 2 postoperative
Title
Walking speed on 10 meters
Description
The patient will be timed when walking 10meters on a graduated corridor. They will be allowed to stop or use a technical help.
Time Frame
Day 0, Week 4, Week 4 postoperative, Week 12 postoperative
Title
Time up and go test (TUG)
Description
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.
Time Frame
Day 0, Week 4, Week 4 postoperative, Week 12 postoperative
Title
Western Ontario McMaster Osteoarthritis Index (WOMAC)
Description
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.
Time Frame
Day 0, Week 4, Week 4 postoperative, Week 12 postoperative
Title
Pain in Analogic Visual Scale (AVS)
Description
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.
Time Frame
Day 0, Week 4, Week 4 postoperative, Week 12 postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier REMY-NERIS, Pr
Phone
02 98 22 33 73
Ext
+33
Email
olivier.remy-neris@univ-brest.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier REMY-NERIS, Pr
Organizational Affiliation
University hospital of Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier REMY-NERIS, Pr
Phone
02 98 22 33 73
Ext
+33
Email
olivier.remy-neris@univ-brest.fr
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Rehabilitation With Personalized Strategies According to Muscle Volume Before Knee Arthroplasty
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