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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318197
Recruitment Status : Not yet recruiting
First Posted : March 23, 2020
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Gonarthrosis Arthroplasty Other: Personalized rehabilitation program with electrostimulation Other: Global rehabilitation program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Difference of isometric strength D0-W4p [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • Osteoarticular illness 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318197


Contacts
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Contact: Olivier REMY-NERIS, Pr 02 98 22 33 73 ext +33 olivier.remy-neris@univ-brest.fr

Locations
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France
CHRU de Brest
Brest, France, 29200
Contact: Olivier REMY-NERIS, Pr    02 98 22 33 73 ext +33    olivier.remy-neris@univ-brest.fr   
Sponsors and Collaborators
University Hospital, Brest
Investigators
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Principal Investigator: Olivier REMY-NERIS, Pr University hospital of Brest
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT04318197    
Other Study ID Numbers: 29BRC.19.0154
First Posted: March 23, 2020    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication.
Supporting Materials: Study Protocol
Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases