GonarthrosisREPERAGENCT04318197
Rehabilitation with Personalized Strategies According to Muscle Volume Before Knee Arthroplasty
A study testing Personalized rehabilitation program with electrostimulation and Global rehabilitation program in people with Gonarthrosis and Arthroplasty, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gonarthrosis, Arthroplasty
- What is being tested?
- Personalized rehabilitation program with electrostimulation and Global rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 18 Dec 2020to 27 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Rehabilitation Strategies According to Muscle Volume Before Knee Arthroplasty: a Pilot Study
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.
- Conditions
- Gonarthrosis, Arthroplasty
- Being tested
- Personalized rehabilitation program with electrostimulation, Global rehabilitation program
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized rehabilitation program with electrostimulationOther
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.
Global rehabilitation programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Global rehabilitation | Active comparator | 2 hours of daily rehabilitation, 3 days per week during 4 weeks Receives: Other: Global rehabilitation program |
| Personalized rehabilitation | Experimental | 2 hours of daily rehabilitation including at least 2 times 20 minutes of electrostimulation on atrophied muscles, 3 days per week during 4 weeks Receives: Other: Personalized rehabilitation program with electrostimulation |
| Classic rehabilitation | No intervention | 40 minutes of rehabilitation, once a week during 4 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of isometric strength D0-W4p
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.
Measured: Day 0 to Week 4 postoperative
Secondary outcomes (7)
Difference of isometric strength D0-W4
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.
Measured: Day 0 to Week 4
Difference of isometric strength D0-W12p
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.
Measured: Day 0 to Week 12 postoperative
Muscles volumes
Quadriceps and hamstring volume as well as all muscles volume of each muscles groups will be evaluated in MRI.
Measured: Day 0, Week 4, Week 2 postoperative
Walking speed on 10 meters
The patient will be timed when walking 10meters on a graduated corridor. They will be allowed to stop or use a technical help.
Measured: Day 0, Week 4, Week 4 postoperative, Week 12 postoperative
Time up and go test (TUG)
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.
Measured: Day 0, Week 4, Week 4 postoperative, Week 12 postoperative
Western Ontario McMaster Osteoarthritis Index (WOMAC)
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.
Measured: Day 0, Week 4, Week 4 postoperative, Week 12 postoperative
Pain in Analogic Visual Scale (AVS)
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.
Measured: Day 0, Week 4, Week 4 postoperative, Week 12 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start18 Dec 2020
- Primary completion27 Dec 2022
- Study completion27 Dec 2022
Why it stopped: Lake of financing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GonarthrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier REMY-NERIS, Pr, Principal investigator, University hospital of Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318197
- Sponsor's protocol ID
- 29BRC.19.0154
- Acronym
- REPERAGE
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2020
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Rehabilitation Strategies According to Muscle Volume Before Knee Arthroplasty: a Pilot Study
- ClinicalTrials.gov ID
- NCT04318197
- Acronym / sponsor ID
- REPERAGE / 29BRC.19.0154
- Conditions
- Gonarthrosis, Arthroplasty
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lake of financing
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 27 Dec 2022 (actual)
- Study completion
- 27 Dec 2022 (actual)
- First posted
- 23 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Global rehabilitation | Active comparator | Other: Global rehabilitation program2 hours of daily rehabilitation, 3 days per week during 4 weeks |
| Personalized rehabilitation | Experimental | Other: Personalized rehabilitation program with electrostimulation2 hours of daily rehabilitation including at least 2 times 20 minutes of electrostimulation on atrophied muscles, 3 days per week during 4 weeks |
| Classic rehabilitation | No intervention | –40 minutes of rehabilitation, once a week during 4 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized rehabilitation program with electrostimulationPatient 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. | Other | Personalized rehabilitation |
| Global rehabilitation programPatient 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. | Other | Global rehabilitation |
Primary outcome
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.
7 secondary outcomes
Difference of isometric strength D0-W4
Time frame: Day 0 to Week 4
Difference of isometric strength D0-W12p
Time frame: Day 0 to Week 12 postoperative
Muscles volumes
Time frame: Day 0, Week 4, Week 2 postoperative
Walking speed on 10 meters
Time frame: Day 0, Week 4, Week 4 postoperative, Week 12 postoperative
Time up and go test (TUG)
Time frame: Day 0, Week 4, Week 4 postoperative, Week 12 postoperative
Western Ontario McMaster Osteoarthritis Index (WOMAC)
Time frame: Day 0, Week 4, Week 4 postoperative, Week 12 postoperative
Pain in Analogic Visual Scale (AVS)
Time frame: Day 0, Week 4, Week 4 postoperative, Week 12 postoperative
Results and safety
The study was stopped early (reason given: Lake of financing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication.
Related trials for Gonarthrosis
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier REMY-NERIS, Pr principal investigator
University hospital of Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized rehabilitation program with electrostimulation and Global rehabilitation program in people with Gonarthrosis and Arthroplasty, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lake of financing). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of isometric strength D0-W4p (time frame: Day 0 to Week 4 postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.