ACL SurgeryReGAINNCT07765173
Muscle Function Following Anterior Cruciate Ligament Reconstruction: Impaired Power Output in Physically Active Individuals
A study testing assessment in people with ACL Surgery, run by Centre Hospitalier Metropole Savoie at 1 site in France.
Trial summary
The goal of this clinical trial is to to determine the extent of the association between objective changes in the muscle function of the knee extensors (strength and power) and the function reported by the patient following ACL reconstruction surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ACL Surgery
- What is being tested?
- assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jun 2026to 8 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring isolated or complex ACL reconstruction (combined with a meniscal injury)
- Patients who are physically active (Tegner score ≥ 4) and wish to resume such activity.
- Patients with no history of surgery on the ipsilateral knee (i.e., native knee).
- Patients able to comply with the study procedures
- Patients who have given their free and informed written consent, having been informed of the purpose of the study, its procedure and its risks.
- Be affiliated to a social security scheme.
Who cannot join
- Patient with comprehension difficulties
- Recurrent rupture of the ipsilateral ACL
- Multi-ligament injuries (i.e., injury to the medial collateral ligament, lateral collateral ligament or posterior cruciate ligament)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Médipôle de Savoie
Challes-les-Eaux, 73190
Vincent Morin, 04 79 26 80 80, urc@ch-metropole-savoie.fr
About this study
The goal of this clinical trial is to to determine the extent of the association between objective changes in the muscle function of the knee extensors (strength and power) and the function reported by the patient following ACL reconstruction surgery. The main questions it aims to answer is:
- Pre- and post-operative (6 months) changes in maximum knee extensor strength following ACL reconstruction, correlated with the IKDC-SKF score.
Read the detailed description
Before surgery :
- The patient will undergo a series of assessment tests, including:
- An assessment of the force-velocity and power-velocity relationships for each leg during a cycling task
- An assessment of unilateral force-velocity and power-velocity relationships during a knee extension task
- An assessment of maximum strength and explosive strength in isometric (static) mode of the knee extensors.
- A questionnaire-based assessment of IKDC-SKF scores. Evaluations will be repeated at 3 and 6 month after surgery ; Patients will be monitored for up to 24 months following their surgery
- Conditions
- ACL Surgery
- Being tested
- assessment
- Keywords
- assessment, recovery, cruciate ligament, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessmentOther
- Assessment of force-velocity and power-velocity relationships in each leg during a cycling task
- Assessment of unilateral force-velocity and power-velocity relationships during a knee extension task
- Assessment of maximum force and explosive force in isometric (static) conditions of the knee extensors.
- Measurement of scores using questionnaires (IKDC-SKF).
| Study group | Role | What they receive |
|---|---|---|
| evaluated group | Experimental | assessment of knee function before and after cruciate ligament surgery Receives: Other: assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of maximum knee extension strength to IKDC-SKF scores
Relationship (r coefficient) between 0-6 month delta of maximum knee extension strength measurements and International Knee Documentation Commitee-SKF scores (100: no limitation)
Measured: 6 month
Secondary outcomes (9)
Peri-operatory trajectory of maximal dynamic force
Trajectory of evolution of F0 (maximal dynamic force) between baseline, 3 and 6 months, compared between legs (linear mixed effect model).
Measured: 0, 3 and 6 month
Peri-operatory trajectory of maximal contraction velocity
Trajectory of evolution of V0 (maximal contraction velocity) between baseline, 3 and 6 months, compared between legs (linear mixed effect model).
Measured: 0, 3 and 6 month
Peri-operatory trajectory of rate of force development
Trajectory of evolution of rate of force development between baseline, 3 and 6 months, compared between legs (linear mixed effect model).
Measured: 0, 3 and 6 month
Peri-operatory trajectory of maximal isometric force
Trajectory of evolution of maximal isometric force (Fmax) between baseline, 3 and 6 months, compared between legs (linear mixed effect model).
Measured: 0, 3 and 6 month
Peri-operatory trajectory of maximal dynamic force during cycling
Trajectory of evolution of maximal dynamic force (F0) during cycling between baseline, 3 and 6 months (linear mixed effect model, one fixed factor).
Measured: 0, 3 and 6 month
Peri-operatory trajectory of maximal contraction velocity during cycling
Trajectory of evolution of maximal contraction velocity (V0) during cycling between baseline, 3 and 6 months (linear mixed effect model, one fixed factor).
Measured: 0, 3 and 6 month
Determinants of fonctional prognosis
Multivariate analysis including the IKDC-SKF score at 24 months as dependant variable and, as predictors :
- the 0-3 month delta of V0, F0, RFD and Fmax during knee extension on the operated leg.
- the severity of the lesion (presence of associated lesions)
- the presence of a pre-operatory rehabilitation.
Measured: 0, 3 and 24 month
Determinants of fonctional prognosis
Multivariate analysis including the recurrence of ACL lesion at 24 months (0/1) as dependant variable and, as predictors :
- the 0-3 month delta of V0, F0, RFD and Fmax during knee extension on the operated leg.
- the severity of the lesion (presence of associated lesions)
- the presence of a pre-operatory rehabilitation.
Measured: 0, 3 and 24 month
Determinants of fonctional prognosis
Multivariate analysis including resuming physical activity at the pre-injury level at 24 months (0/1) as dependant variable and, as predictors :
- the 0-3 month delta of V0, F0, RFD and Fmax during knee extension on the operated leg.
- the severity of the lesion (presence of associated lesions)
- the presence of a pre-operatory rehabilitation.
Measured: 0, 3 and 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start8 Jun 2026
- Primary completion8 Jun 2030 (estimated)
- Study completion8 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL SurgeryStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Metropole Savoie
- Sponsor type
- University, hospital or other
- Collaborators
- Université Savoie Mont Blanc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765173
- Sponsor's protocol ID
- CHMS26001
- Acronym
- ReGAIN
- Status last verified
- Aug 2026
- First submitted
- 1 Jun 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Function Following Anterior Cruciate Ligament Reconstruction: Impaired Power Output in Physically Active Individuals
- ClinicalTrials.gov ID
- NCT07765173
- Acronym / sponsor ID
- ReGAIN / CHMS26001
- Conditions
- ACL Surgery
- Keywords
- assessment, recovery, cruciate ligament, surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Centre Hospitalier Metropole SavoieUniversity, hospital or other
- Collaborators
- Université Savoie Mont Blanc
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- 8 Jun 2030 (estimated)
- Study completion
- 8 Jun 2030 (estimated)
- First posted
- 14 Aug 2026 (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.
The goal of this clinical trial is to to determine the extent of the association between objective changes in the muscle function of the knee extensors (strength and power) and the function reported by the patient following ACL reconstruction surgery. The main questions it aims to answer is:
- Pre- and post-operative (6 months) changes in maximum knee extensor strength following ACL reconstruction, correlated with the IKDC-SKF score.
Detailed description
Before surgery :
- The patient will undergo a series of assessment tests, including:
- An assessment of the force-velocity and power-velocity relationships for each leg during a cycling task
- An assessment of unilateral force-velocity and power-velocity relationships during a knee extension task
- An assessment of maximum strength and explosive strength in isometric (static) mode of the knee extensors.
- A questionnaire-based assessment of IKDC-SKF scores. Evaluations will be repeated at 3 and 6 month after surgery ; Patients will be monitored for up to 24 months following their surgery
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| evaluated group | Experimental | Other: assessmentassessment of knee function before and after cruciate ligament surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients requiring isolated or complex ACL reconstruction (combined with a meniscal injury)
- Patients who are physically active (Tegner score ≥ 4) and wish to resume such activity.
- Patients with no history of surgery on the ipsilateral knee (i.e., native knee).
- Patients able to comply with the study procedures
- Patients who have given their free and informed written consent, having been informed of the purpose of the study, its procedure and its risks.
Key exclusion criteria (3 listed)
- Patient with comprehension difficulties
- Recurrent rupture of the ipsilateral ACL
- Multi-ligament injuries (i.e., injury to the medial collateral ligament, lateral collateral ligament or posterior cruciate ligament)
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 |
|---|---|---|
| assessment* Assessment of force-velocity and power-velocity relationships in each leg during a cycling task * Assessment of unilateral force-velocity and power-velocity relationships during a knee extension task * Assessment of maximum force and explosive force in isometric (static) conditions of the knee extensors. * Measurement of scores using questionnaires (IKDC-SKF). | Other | evaluated group |
Primary outcome
Correlation of maximum knee extension strength to IKDC-SKF scores
Time frame: 6 month
Relationship (r coefficient) between 0-6 month delta of maximum knee extension strength measurements and International Knee Documentation Commitee-SKF scores (100: no limitation)
9 secondary outcomes
Peri-operatory trajectory of maximal dynamic force
Time frame: 0, 3 and 6 month
Peri-operatory trajectory of maximal contraction velocity
Time frame: 0, 3 and 6 month
Peri-operatory trajectory of rate of force development
Time frame: 0, 3 and 6 month
Peri-operatory trajectory of maximal isometric force
Time frame: 0, 3 and 6 month
Peri-operatory trajectory of maximal dynamic force during cycling
Time frame: 0, 3 and 6 month
Peri-operatory trajectory of maximal contraction velocity during cycling
Time frame: 0, 3 and 6 month
Determinants of fonctional prognosis
Time frame: 0, 3 and 24 month
Determinants of fonctional prognosis
Time frame: 0, 3 and 24 month
Determinants of fonctional prognosis
Time frame: 0, 3 and 24 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing assessment in people with ACL Surgery, run by Centre Hospitalier Metropole Savoie 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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 14 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact leo blervaque (04.79.96.58.13, leo.blervaque@ch-metropole-savoie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of maximum knee extension strength to IKDC-SKF scores (time frame: 6 month). 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 14 Aug 2026.