Rehabilitation with Personalized Strategies According to Muscle Volume Before Knee Arthroplasty

NCT ID: NCT04318197

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-18

Study Completion Date

2022-12-27

Brief Summary

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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.

Detailed Description

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Conditions

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Gonarthrosis Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Global rehabilitation

2 hours of daily rehabilitation, 3 days per week during 4 weeks

Group Type ACTIVE_COMPARATOR

Global rehabilitation program

Intervention Type OTHER

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.

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

Group Type EXPERIMENTAL

Personalized rehabilitation program with electrostimulation

Intervention Type OTHER

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.

Classic rehabilitation

40 minutes of rehabilitation, once a week during 4 weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier REMY-NERIS, Pr

Role: PRINCIPAL_INVESTIGATOR

University hospital of Brest

Locations

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CHRU de Brest

Brest, France, France

Site Status

Countries

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France

Other Identifiers

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29BRC.19.0154

Identifier Type: -

Identifier Source: org_study_id

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