Anterior Cruciate Ligament InjuriesFoVeANCT05712109
Changes in the Force-velocity Relationship of Knee Muscles After ACL Reconstruction
An observational study of Anterior Cruciate Ligament Injuries and Muscle Weakness, run by University Hospital, Caen at 1 site in France.
Trial summary
Anterior cruciate ligament (ACL) tear is a frequent and devastating injury in sport, especially in pivoting-contact disciplines. In many cases, athletes will undergo an ACL reconstruction (ACL-R) for recovering knee stability, preventing further injuries and returning to sport (RTS). Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Muscle Weakness
- What is being tested?
- Follow-up after Anterior cruciate ligament reconstruction
- How many people
- 103 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2017to 5 Feb 2023
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 16 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All sports patients included in the sport medicine follow-up protocole with isokinetic muscular assessment at 4 months and 8 months after ACL reconstruction surgery since January 2017
Who may be able to join
- Patients who have had an ACL reconstruction surgery (isolated or associated with other meniscal or ligamentary surgery)
- Patient included in the sport medicine follow-up protocole with intermediate and final isokinetic muscular assessment at 4 months and8 months after surgery respectively
- Patients who completed both tests at the 60°/s and 240°/s velocities
Who cannot join
- Patient who did not participate in all follow-up consultations and isokinetic muscular assessments
- Cognitive or sensory impairment making it impossible to understand the information form
- Neurological, traumatic or osteoarticular history responsible for muscle imbalance prior to surgery
Trial locations and contacts
1 site in 1 country.
About this study
Anterior cruciate ligament (ACL) tear is a frequent and devastating injury in sport, especially in pivoting-contact disciplines. In many cases, athletes will undergo an ACL reconstruction (ACL-R) for recovering knee stability, preventing further injuries and returning to sport (RTS). Among the criteria for RTS, knee muscle strength is the most used objective criteria and especially the symmetry of knee flexors and/or extensors between the operated and uninjured knee.
Isokinetic testing of knee muscle strength is considered as a reference for knee muscle testing during the follow up stages after ACL-R. This evaluation allows to measure the strength (torque) of knee flexors and extensors at several angular velocities. However, there is no relevant litterature about the force-velocity (Fo-v) relationship of knee flexors and extensors after ACL-R.
The present study aimed to evaluate and test the differences between the Fo-v relationship parameters between the operated and uninjured knees at 4 months and 8 months after ACL-R, using the 2-points method with isokinetic testing. Also, the investigators aimed to test the impact of the type of surgery (patellar tendon autograft vs. hamstring tendon autograft) on the Fo-v relationship after ACL-R
- Being tested
- Follow-up after Anterior cruciate ligament reconstruction
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up after Anterior cruciate ligament reconstructionOther
The patients were referred to the sport medicine department for the post ACL-R follow-up including isokinetic knee muscle strength evaluations at 4 months and 8.months after the surgery
| Study group | Role | What they receive |
|---|---|---|
| ACL group | The patients were referred to the sport medicine department for the post ACL-R follow-up including isokinetic knee muscle strength evaluations at 4 months and 8 months after the surgery Receives: Other: Follow-up after Anterior cruciate ligament reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in strength
Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer at two angular velocities of 60°/s and 240°/s respectively
Measured: Time Frame: ACL group: Two evaluations on both injured and healthy knees: (1) 4 months after surgery and (2) 8 months after surgery; Routine practice following guidelines
Change in the force-velocity relationship
Calculation of the corresponding slope and maximal force (Y-intercept) of the regression line of the force-velocity curve
Measured: Time Frame: ACL group: Two evaluations on both injured and healthy knees: (1) 4 months after surgery and (2) 8 months after surgery; Routine practice following guidelines
Secondary outcomes (3)
Individual characteristics
Personal characteristics recorded in the medical report as age, gender, type of sport and sport level of practice and return to sport after the surgery
Measured: Time Frame: ACL group: Two evaluations on both injured and healthy knees: (1) 4 months after surgery and (2) 8 months after surgery; Routine practice following guidelines
Injury characteristics
Injury characteristics recorded in the medical report as the type of injury (ACL only, ACL and meniscus, ACL with other ligament injury, recurrent ACL injury) the time before surgery, the type of rehabilitation before and after surgery
Measured: Time Frame: ACL group: Two evaluations on both injured and healthy knees: (1) 4 months after surgery and (2) 8 months after surgery; Routine practice following guidelines
Surgery characteristics
Surgery characteristics recorded in the medical report as the type of surgery, the surgery duration and tourniquet time
Measured: Time Frame: ACL group: Two evaluations on both injured and healthy knees: (1) 4 months after surgery and (2) 8 months after surgery; Routine practice following guidelines
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start15 Jan 2017
- Primary completion15 Jan 2020
- Study completion5 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712109
- Sponsor's protocol ID
- FoVeA
- Acronym
- FoVeA
- Status last verified
- Mar 2023
- First submitted
- 26 Jan 2023
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in the Force-velocity Relationship of Knee Muscles After ACL Reconstruction
- ClinicalTrials.gov ID
- NCT05712109
- Acronym / sponsor ID
- FoVeA / FoVeA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 5 Feb 2023 (actual)
- First posted
- 3 Feb 2023 (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.
Anterior cruciate ligament (ACL) tear is a frequent and devastating injury in sport, especially in pivoting-contact disciplines. In many cases, athletes will undergo an ACL reconstruction (ACL-R) for recovering knee stability, preventing further injuries and returning to sport (RTS). Among the criteria for RTS, knee muscle strength is the most used objective criteria and especially the symmetry of knee flexors and/or extensors between the operated and uninjured knee.
Isokinetic testing of knee muscle strength is considered as a reference for knee muscle testing during the follow up stages after ACL-R. This evaluation allows to measure the strength (torque) of knee flexors and extensors at several angular velocities. However, there is no relevant litterature about the force-velocity (Fo-v) relationship of knee flexors and extensors after ACL-R.
The present study aimed to evaluate and test the differences between the Fo-v relationship parameters between the operated and uninjured knees at 4 months and 8 months after ACL-R, using the 2-points method with isokinetic testing. Also, the investigators aimed to test the impact of the type of surgery (patellar tendon autograft vs. hamstring tendon autograft) on the Fo-v relationship after ACL-R
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACL group | – | Other: Follow-up after Anterior cruciate ligament reconstructionThe patients were referred to the sport medicine department for the post ACL-R follow-up including isokinetic knee muscle strength evaluations at 4 months and 8 months after the surgery |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All sports patients included in the sport medicine follow-up protocole with isokinetic muscular assessment at 4 months and 8 months after ACL reconstruction surgery since January 2017
Key inclusion criteria (3 listed)
- Patients who have had an ACL reconstruction surgery (isolated or associated with other meniscal or ligamentary surgery)
- Patient included in the sport medicine follow-up protocole with intermediate and final isokinetic muscular assessment at 4 months and8 months after surgery respectively
- Patients who completed both tests at the 60°/s and 240°/s velocities
Key exclusion criteria (3 listed)
- Patient who did not participate in all follow-up consultations and isokinetic muscular assessments
- Cognitive or sensory impairment making it impossible to understand the information form
- Neurological, traumatic or osteoarticular history responsible for muscle imbalance prior to surgery
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 |
|---|---|---|
| Follow-up after Anterior cruciate ligament reconstructionThe patients were referred to the sport medicine department for the post ACL-R follow-up including isokinetic knee muscle strength evaluations at 4 months and 8.months after the surgery | Other | ACL group |
Primary outcome
Change in strength
Time frame: Time Frame: ACL group: Two evaluations on both injured and healthy knees: (1) 4 months after surgery and (2) 8 months after surgery; Routine practice following guidelines
Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer at two angular velocities of 60°/s and 240°/s respectively
Change in the force-velocity relationship
Time frame: Time Frame: ACL group: Two evaluations on both injured and healthy knees: (1) 4 months after surgery and (2) 8 months after surgery; Routine practice following guidelines
Calculation of the corresponding slope and maximal force (Y-intercept) of the regression line of the force-velocity curve
3 secondary outcomes
Individual characteristics
Time frame: Time Frame: ACL group: Two evaluations on both injured and healthy knees: (1) 4 months after surgery and (2) 8 months after surgery; Routine practice following guidelines
Injury characteristics
Time frame: Time Frame: ACL group: Two evaluations on both injured and healthy knees: (1) 4 months after surgery and (2) 8 months after surgery; Routine practice following guidelines
Surgery characteristics
Time frame: Time Frame: ACL group: Two evaluations on both injured and healthy knees: (1) 4 months after surgery and (2) 8 months after surgery; Routine practice following guidelines
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Injuries and Muscle Weakness, run by University Hospital, Caen 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 3 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: finished, as of the sponsor's last update on 26 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in strength (time frame: Time Frame: ACL group: Two evaluations on both injured and healthy knees: (1) 4 months after surgery and (2) 8 months after surgery; Routine practice following guidelines). The study lists 2 primary outcomes in all. 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 26 Mar 2025.