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Clinical Trials/NCT04318197
NCT04318197
Terminated
Not Applicable

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

University Hospital, Brest1 site in 1 country15 target enrollmentDecember 18, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gonarthrosis
Sponsor
University Hospital, Brest
Enrollment
15
Locations
1
Primary Endpoint
Difference of isometric strength D0-W4p
Status
Terminated
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 18, 2020
End Date
December 27, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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 Outcomes

  • Time up and go test (TUG)(Day 0, Week 4, Week 4 postoperative, Week 12 postoperative)
  • Western Ontario McMaster Osteoarthritis Index (WOMAC)(Day 0, Week 4, Week 4 postoperative, Week 12 postoperative)
  • Difference of isometric strength D0-W12p(Day 0 to Week 12 postoperative)
  • Walking speed on 10 meters(Day 0, Week 4, Week 4 postoperative, Week 12 postoperative)
  • Pain in Analogic Visual Scale (AVS)(Day 0, Week 4, Week 4 postoperative, Week 12 postoperative)
  • Muscles volumes(Day 0, Week 4, Week 2 postoperative)
  • Difference of isometric strength D0-W4(Day 0 to Week 4)

Study Sites (1)

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