Anterior Cruciate Ligament InjuryWEAKNESSNCT03200678
WEakness and Atrophy: isoKinetic With Surface Electromyography Assessment in ACL Surgery
A study testing isokinetic assessment in people with Anterior Cruciate Ligament Injury and Muscle Weakness, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial summary
An assessment of the effect of surgical anterior cruciate ligament (ACL) on thigh muscles is critical to the improvement of knee rehabilitation and preservation. However, if a large number of studies had rated surgical technics, giving high results level for ACL reconstruction (ACLR), muscle recovery is still… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injury, Muscle Weakness
- What is being tested?
- isokinetic assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 7 May 2018to Sep 2023
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ACLR group :
- men or woman
- 18 to 45 years old
- No injuries sequels on contralateral limb
- No contraindication to magnetic resonance imaging
- Control group :
Show all 10Show fewer
- men or woman
- 18 to 45 years old
- No limb injuries sequels
- No contraindication to magnetic resonance imaging
Who cannot join
- age less than 18 years
- limb injuries sequels
- contraindication to magnetic resonance imaging
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital d'Instruction des Armées Clermont-Tonnerre
Brest, 29240 Brest Cedex 9
About this study
Official title: Motor Unit Recruitment Study With Fatigue Testing: 9 Months Following up After Anterior Cruciate Ligament Surgery.
An assessment of the effect of surgical anterior cruciate ligament (ACL) on thigh muscles is critical to the improvement of knee rehabilitation and preservation. However, if a large number of studies had rated surgical technics, giving high results level for ACL reconstruction (ACLR), muscle recovery is still conditioning functional success. Furthermore there is no consensus about criteria in return to sport.
The aim of this exploratory study is to quantify the mechanisms of neuromuscular adaptation of muscle thigh after ACL surgery.
Read the detailed description
The aim of this study is to assess the qualitative and quantitative variations of the strength, work and fatigue of the thigh muscles after ACL surgery. The reference is the preoperative assessment (V1), the variation is measured on V2 (measurements at 3 months) and V3 (measures at 9 months). Each patient is his own control. In addition, a control group of healthy subjects is used to determine level of significance of each parameter.
- Conditions
- Anterior Cruciate Ligament Injury, Muscle Weakness
- Being tested
- isokinetic assessment
- Keywords
- knee muscle, strength, fatigue, MRI, ACL
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Muscle Weakness, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isokinetic assessmentOther
muscle torque assessement
| Study group | Role | What they receive |
|---|---|---|
| ACLR Group | Experimental | experimental: ACL surgery Intervention: isokinetic assessment Receives: Other: isokinetic assessment |
| Control group | Other | other Intervention: isokinetic assessment Receives: Other: isokinetic assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle torque
Newton.meter (N.m)
Measured: Change is being assessed between preoperative assessment (V1), measurement at 3 months (V2), measures at 9 months (V3)
Secondary outcomes (1)
muscle work
Joule (J)
Measured: Change is being assessed between preoperative assessment (V1), measurement at 3 months (V2) and measures at 9 months (V3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start7 May 2018
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuryStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique Tardy, Principal investigator, Direction Centrale du Service de Santé des Armées
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200678
- Sponsor's protocol ID
- 2017-A00301-52
- Other IDs
- 2017RC01
- Acronym
- WEAKNESS
- Status last verified
- Apr 2022
- First submitted
- 23 May 2017
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grimandi R, Tissier F, Garetier M, Labban J, Gerard R, Courtois-Communier E, Andro C, Bisseriex H, Gunepin FX, Rannou F, Giroux-Metges MA. Validity of the Uninjured Limb as a Control for Preoperative Assessment in Anterior Cruciate Ligament Reconstruction. J Orthop Res. 2025 May;43(5):962-972. doi: 10.1002/jor.26057. Epub 2025 Feb 21.
PubMed 39981758
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Unit Recruitment Study With Fatigue Testing: 9 Months Following up After Anterior Cruciate Ligament Surgery.
- ClinicalTrials.gov ID
- NCT03200678
- Acronym / sponsor ID
- WEAKNESS / 2017-A00301-52
- Conditions
- Anterior Cruciate Ligament Injury, Muscle Weakness
- Keywords
- knee muscle, strength, fatigue, MRI, ACL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 7 May 2018 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 27 Jun 2017 (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.
An assessment of the effect of surgical anterior cruciate ligament (ACL) on thigh muscles is critical to the improvement of knee rehabilitation and preservation. However, if a large number of studies had rated surgical technics, giving high results level for ACL reconstruction (ACLR), muscle recovery is still conditioning functional success. Furthermore there is no consensus about criteria in return to sport.
The aim of this exploratory study is to quantify the mechanisms of neuromuscular adaptation of muscle thigh after ACL surgery.
Detailed description
The aim of this study is to assess the qualitative and quantitative variations of the strength, work and fatigue of the thigh muscles after ACL surgery. The reference is the preoperative assessment (V1), the variation is measured on V2 (measurements at 3 months) and V3 (measures at 9 months). Each patient is his own control. In addition, a control group of healthy subjects is used to determine level of significance of each parameter.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACLR Group | Experimental | Other: isokinetic assessmentexperimental: ACL surgery Intervention: isokinetic assessment |
| Control group | Other | Other: isokinetic assessmentother Intervention: isokinetic assessment |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- men or woman
- 18 to 45 years old
- No injuries sequels on contralateral limb
- No contraindication to magnetic resonance imaging
- men or woman
Key exclusion criteria (3 listed)
- age less than 18 years
- limb injuries sequels
- contraindication to magnetic resonance imaging
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 |
|---|---|---|
| isokinetic assessmentmuscle torque assessement | Other | ACLR Group, Control group |
Primary outcome
muscle torque
Time frame: Change is being assessed between preoperative assessment (V1), measurement at 3 months (V2), measures at 9 months (V3)
Newton.meter (N.m)
1 secondary outcome
muscle work
Time frame: Change is being assessed between preoperative assessment (V1), measurement at 3 months (V2) and measures at 9 months (V3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Derived from this study: PubMed 39981758Grimandi R, Tissier F, Garetier M, Labban J, Gerard R, Courtois-Communier E, Andro C, Bisseriex H, Gunepin FX, Rannou F, Giroux-Metges MA. Validity of the Uninjured Limb as a Control for Preoperative Assessment in Anterior Cruciate Ligament Reconstruction. J Orthop Res. 2025 May;43(5):962-972. doi: 10.1002/jor.26057. Epub 2025 Feb 21.
- Individual participant dataSharing planned: No
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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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.
Dominique Tardy principal investigator
Direction Centrale du Service de Santé des Armées
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing isokinetic assessment in people with Anterior Cruciate Ligament Injury and Muscle Weakness, run by Direction Centrale du Service de Santé des Armées 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 10 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: status not confirmed, as of the sponsor's last update on 14 Apr 2022. 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?
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?
muscle torque (time frame: Change is being assessed between preoperative assessment (V1), measurement at 3 months (V2), measures at 9 months (V3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03200678, which also lists 1 linked publication.
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 Apr 2022.