Clinical trial NCT04318197: Rehabilitation with Personalized Strategies According to Muscle Volume Before Knee Arthroplasty
Official title: Personalized Rehabilitation Strategies According to Muscle Volume Before Knee Arthroplasty: a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gonarthrosis
Arthroplasty
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Difference of isometric strength D0-W4p
timeFrame: Day 0 to Week 4 postoperative
Secondary outcomes:
measure: Difference of isometric strength D0-W4
timeFrame: Day 0 to Week 4
measure: Difference of isometric strength D0-W12p
timeFrame: Day 0 to Week 12 postoperative
measure: Muscles volumes
timeFrame: Day 0, Week 4, Week 2 postoperative
measure: Walking speed on 10 meters
timeFrame: Day 0, Week 4, Week 4 postoperative, Week 12 postoperative
measure: Time up and go test (TUG)
timeFrame: Day 0, Week 4, Week 4 postoperative, Week 12 postoperative
measure: Western Ontario McMaster Osteoarthritis Index (WOMAC)
timeFrame: Day 0, Week 4, Week 4 postoperative, Week 12 postoperative
measure: Pain in Analogic Visual Scale (AVS)
timeFrame: Day 0, Week 4, Week 4 postoperative, Week 12 postoperative
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: University hospital of Brest
name: Olivier REMY-NERIS, Pr
role: PRINCIPAL_INVESTIGATOR
References: