ACL - Anterior Cruciate Ligament DeficiencyPREDICT-ACLNCT04071912
Isokinetic Muscular Assessment After ACL Ligamentoplasty: Study of Factors Predictive of Muscle Imbalance.
An observational study of ACL - Anterior Cruciate Ligament Deficiency and Muscle Weakness, run by University Hospital, Caen at 1 site in France.
Trial summary
Despite advances in surgery and rehabilitation, the return to sport after anterior cruciate ligament (ACL) reconstruction surgery remains a major challenge. challenge. Among the objective criteria retained, the isokinetic muscle strength assessment is an increasingly practiced evaluation and it is recommended to carry… Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- ACL - Anterior Cruciate Ligament Deficiency, Muscle Weakness
- How many people
- 113 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2019to 1 Feb 2020
- 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 3-4 months and 6-8 months after ACL reconstruction surgery since January 2016
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 3-4 months and 6-8 mnths after surgery respectively
- Patient who received the information form
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
Despite advances in surgery and rehabilitation, the return to sport after anterior cruciate ligament (ACL) reconstruction surgery remains a major challenge.
challenge. Among the objective criteria retained, the isokinetic muscle strength assessment is an increasingly practiced evaluation and it is recommended to carry out follow-ups at 3-4 months (intermediate) and at 6-8 months (final) after surgery. However, the factors associated with muscle imbalance are uncertain and the threshold values of the intermediate isokinetic strength test (3-4 months) are inconsistent. In a retrospective analysis, the investigators aim to assess the predictive criteria for muscle imbalance after ACL reconstruction surgery.
Read the detailed description
The investigators aim to retrospectively studied all sports patients who had a muscle evaluation at 3-4 months and 6-8 months after anterior cruciate ligament (ACL) reconstruction surgery since January 2016. The objective criterion were based on the international guidelines for muscle imbalance after ACL surgery and return to sport, as a muscle deficit of less than 20% on knee extensor muslces and less than 10% on knee flexor muscles of the operated knee (vs. healthy).
The investigators will study the predictive analysis of the intermediate muscle strength test to predict the risk of muscle imbalance on the final isokinetic muscle strength assessment. The investigators will also study the individual, injury and surgical criteria associated with muscle imbalance.
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ACL | All sports patients who had a muscle evaluation at 3-4 months and 6-8 months after ACL ligamentoplasty since January 2016 |
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.
Measured: ACL group: Two evaluations on both injured and healthy knees: (1) 3 months after surgery and (2) 7 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: ACL group: Two follow-up medical consultations: (1) 3 months after surgery and (2) 7 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: ACL group: Two follow-up medical consultations: (1) 3 months after surgery and (2) 7 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: ACL group: Two follow-up medical consultations: (1) 3 months after surgery and (2) 7 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 posted28 Aug 2019
- Study start1 Oct 2019
- Primary completion1 Dec 2019
- Study completion1 Feb 2020
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 ACL - Anterior Cruciate Ligament DeficiencyStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM U1075 COMETE, UNICAEN, Caen France
- Responsible party
- Principal investigator, Joffrey DRIGNY, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071912
- Sponsor's protocol ID
- PREDICT-ACL
- Acronym
- PREDICT-ACL
- Status last verified
- Jul 2020
- First submitted
- 26 Aug 2019
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Drigny J, Ferrandez C, Gauthier A, Guermont H, Praz C, Reboursiere E, Hulet C. Knee strength symmetry at 4 months is associated with criteria and rates of return to sport after anterior cruciate ligament reconstruction. Ann Phys Rehabil Med. 2022 Jun;65(4):101646. doi: 10.1016/j.rehab.2022.101646. Epub 2022 Apr 30.
PubMed 35167984
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isokinetic Muscular Assessment After ACL Ligamentoplasty: Study of Factors Predictive of Muscle Imbalance.
- ClinicalTrials.gov ID
- NCT04071912
- Acronym / sponsor ID
- PREDICT-ACL / PREDICT-ACL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- INSERM U1075 COMETE, UNICAEN, Caen France
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 28 Aug 2019 (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.
Despite advances in surgery and rehabilitation, the return to sport after anterior cruciate ligament (ACL) reconstruction surgery remains a major challenge.
challenge. Among the objective criteria retained, the isokinetic muscle strength assessment is an increasingly practiced evaluation and it is recommended to carry out follow-ups at 3-4 months (intermediate) and at 6-8 months (final) after surgery. However, the factors associated with muscle imbalance are uncertain and the threshold values of the intermediate isokinetic strength test (3-4 months) are inconsistent. In a retrospective analysis, the investigators aim to assess the predictive criteria for muscle imbalance after ACL reconstruction surgery.
Detailed description
The investigators aim to retrospectively studied all sports patients who had a muscle evaluation at 3-4 months and 6-8 months after anterior cruciate ligament (ACL) reconstruction surgery since January 2016. The objective criterion were based on the international guidelines for muscle imbalance after ACL surgery and return to sport, as a muscle deficit of less than 20% on knee extensor muslces and less than 10% on knee flexor muscles of the operated knee (vs. healthy).
The investigators will study the predictive analysis of the intermediate muscle strength test to predict the risk of muscle imbalance on the final isokinetic muscle strength assessment. The investigators will also study the individual, injury and surgical criteria associated with muscle imbalance.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACL | – | –All sports patients who had a muscle evaluation at 3-4 months and 6-8 months after ACL ligamentoplasty since January 2016 |
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 3-4 months and 6-8 months after ACL reconstruction surgery since January 2016
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 3-4 months and 6-8 mnths after surgery respectively
- Patient who received the information form
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.
Primary outcome
Change in Strength
Time frame: ACL group: Two evaluations on both injured and healthy knees: (1) 3 months after surgery and (2) 7 months after surgery; Routine practice following guidelines
Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer.
3 secondary outcomes
Individual characteristics
Time frame: ACL group: Two follow-up medical consultations: (1) 3 months after surgery and (2) 7 months after surgery; Routine practice following guidelines
Injury characteristics
Time frame: ACL group: Two follow-up medical consultations: (1) 3 months after surgery and (2) 7 months after surgery; Routine practice following guidelines
Surgery characteristics
Time frame: ACL group: Two follow-up medical consultations: (1) 3 months after surgery and (2) 7 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 14 Jul 2020.
- Derived from this study: PubMed 35167984Drigny J, Ferrandez C, Gauthier A, Guermont H, Praz C, Reboursiere E, Hulet C. Knee strength symmetry at 4 months is associated with criteria and rates of return to sport after anterior cruciate ligament reconstruction. Ann Phys Rehabil Med. 2022 Jun;65(4):101646. doi: 10.1016/j.rehab.2022.101646. Epub 2022 Apr 30.
- Individual participant dataSharing planned: Undecided
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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 ACL - Anterior Cruciate Ligament Deficiency 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 14 Jul 2020. 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: ACL group: Two evaluations on both injured and healthy knees: (1) 3 months after surgery and (2) 7 months after surgery; Routine practice following guidelines). 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 NCT04071912, 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 Jul 2020.