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Rehabilitation with Personalized Strategies According to Muscle Volume Before Knee Arthroplasty

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04318197
Acronym
REPERAGE
Enrollment
15
Registered
2020-03-23
Start date
2020-12-18
Completion date
2022-12-27
Last updated
2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Gonarthrosis

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.

Interventions

OTHERPersonalized 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.

OTHERGlobal 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.

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Difference of isometric strength D0-W4pDay 0 to Week 4 postoperativeIsometric 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

MeasureTime frameDescription
Difference of isometric strength D0-W12pDay 0 to Week 12 postoperativeIsometric 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 volumesDay 0, Week 4, Week 2 postoperativeQuadriceps and hamstring volume as well as all muscles volume of each muscles groups will be evaluated in MRI.
Walking speed on 10 metersDay 0, Week 4, Week 4 postoperative, Week 12 postoperativeThe patient will be timed when walking 10meters on a graduated corridor. They will be allowed to stop or use a technical help.
Difference of isometric strength D0-W4Day 0 to Week 4Isometric strength of quadriceps (QS) and hamstring (HS) will be measured on isokinetic bench and the difference between D0 and W4 (W4) will be calculated.
Western Ontario McMaster Osteoarthritis Index (WOMAC)Day 0, Week 4, Week 4 postoperative, Week 12 postoperativeWOMAC 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)Day 0, Week 4, Week 4 postoperative, Week 12 postoperativeThe 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 up and go test (TUG)Day 0, Week 4, Week 4 postoperative, Week 12 postoperativeThe 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026