ACL InjuryPREDICT-ACLv2NCT05897970
Association Between 4-Month Isokinetic Testing Measures and Second Knee Injuries After Primary Anterior Cruciate Ligament Reconstruction
An observational study of ACL Injury and Knee Injuries, run by University Hospital, Caen at 1 site in France.
Trial summary
Anterior cruciate ligament (ACL) is a frequent and disabling injury in athletes. Most of the time, ACL reconstruction (ACLR) is consider for regaining function and returning to preinjury sports while reducing the risk of secondary injuries. Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- ACL Injury, Knee Injuries, Muscle Weakness
- What is being tested?
- Return-to-sport (RTS) follow-up
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2021to 1 May 2023
- 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
- Child, Adult
Study population: All sports patients included in the sport medicine follow-up protocole with isokinetic muscular assessment at 3-4 months after ACL reconstruction surgery since January 2017 with a minium 2 years follow-up in the sports medicine department, Return To Sport Process
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 Patient who received the information form Patients with access to the Internet
Who cannot join
- Patient who did not participate in all follow-up consultations and isokinetic muscular assessments Patients who had a previous knee surgery before the ACLR 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
Official title: Association Between 4-Month Isokinetic Testing Measures and Second Knee Injuries After
Anterior cruciate ligament (ACL) is a frequent and disabling injury in athletes. Most of the time, ACL reconstruction (ACLR) is consider for regaining function and returning to preinjury sports while reducing the risk of secondary injuries. However, the risk of secondary severe knee injury is increased after ACLR, especially in athletes returning to strenuous activities. If strength symmetry is considered as an important factor in the Return-to-sport (RTS) decision, there is conflicting data about the association between strength symmetry and the risk of second knee injury after ACLR. The main objective of this study was to test if knee muscles strength symmetry at 4 months was associated with the psychological readiness and incidence of subsequent severe injury of both knees at a minimum 2 years follow-up after ACL-R.
- Conditions
- ACL Injury, Knee Injuries, Muscle Weakness
- Being tested
- Return-to-sport (RTS) follow-up
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Knee Injuries, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Return-to-sport (RTS) follow-upDiagnostic test
All sports patients who had a muscle evaluation at 3-4 months after ACLR since January 2017
| Study group | Role | What they receive |
|---|---|---|
| ACLR patients with Return-to-sport (RTS) follow-up | All sports patients who had a muscle evaluation at 3-4 months after ACLR since January 2017 Receives: Diagnostic Test: Return-to-sport (RTS) follow-up |
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: 3-4 months after surgery; Routine practice following guidelines]
Secondary outcomes (4)
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 and severe reinjury on the operated knee or contralateral knee.
Measured: ACLR group: Two follow-up medical consultations: (1) 4 months after surgery and (2) 2 years after the surgery for return to sport and reinjury;
Surgery characteristics
Surgery characteristics recorded in the medical report as the type of surgery, the surgery duration
Measured: ACLR group: Two follow-up medical consultations 4 months after surgery
Re-injuries
Web based questionnaire about any sever knee injury (meniscus or ACL) after the primary ACLR
Measured: ACLR group: One evaluation with a minimum 2 years follow-up after the surgery
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) scale.
Web based questionnaire with completion of the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) scale.
Measured: ACLR group: One evaluation with a minimum 2 years follow-up after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 May 2021
- Primary completion1 May 2021
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897970
- Sponsor's protocol ID
- PREDICT-ACLv2
- Acronym
- PREDICT-ACLv2
- Status last verified
- Jun 2023
- First submitted
- 1 Jun 2023
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- Association Between 4-Month Isokinetic Testing Measures and Second Knee Injuries After
- ClinicalTrials.gov ID
- NCT05897970
- Acronym / sponsor ID
- PREDICT-ACLv2 / PREDICT-ACLv2
- Conditions
- ACL Injury, Knee Injuries, Muscle Weakness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 12 Jun 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) is a frequent and disabling injury in athletes. Most of the time, ACL reconstruction (ACLR) is consider for regaining function and returning to preinjury sports while reducing the risk of secondary injuries. However, the risk of secondary severe knee injury is increased after ACLR, especially in athletes returning to strenuous activities. If strength symmetry is considered as an important factor in the Return-to-sport (RTS) decision, there is conflicting data about the association between strength symmetry and the risk of second knee injury after ACLR. The main objective of this study was to test if knee muscles strength symmetry at 4 months was associated with the psychological readiness and incidence of subsequent severe injury of both knees at a minimum 2 years follow-up after ACL-R.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACLR patients with Return-to-sport (RTS) follow-up | – | Diagnostic Test: Return-to-sport (RTS) follow-upAll sports patients who had a muscle evaluation at 3-4 months after ACLR since January 2017 |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- 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 after ACL reconstruction surgery since January 2017 with a minium 2 years follow-up in the sports medicine department, Return To Sport Process
Key inclusion criteria (1 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 Patient who received the information form Patients with access to the Internet
Key exclusion criteria (1 listed)
- Patient who did not participate in all follow-up consultations and isokinetic muscular assessments Patients who had a previous knee surgery before the ACLR 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 |
|---|---|---|
| Return-to-sport (RTS) follow-upAll sports patients who had a muscle evaluation at 3-4 months after ACLR since January 2017 | Diagnostic test | ACLR patients with Return-to-sport (RTS) follow-up |
Primary outcome
Change in Strength
Time frame: ACL group: Two evaluations on both injured and healthy knees: 3-4 months after surgery; Routine practice following guidelines]
Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer.
4 secondary outcomes
Individual characteristics
Time frame: ACLR group: Two follow-up medical consultations: (1) 4 months after surgery and (2) 2 years after the surgery for return to sport and reinjury;
Surgery characteristics
Time frame: ACLR group: Two follow-up medical consultations 4 months after surgery
Re-injuries
Time frame: ACLR group: One evaluation with a minimum 2 years follow-up after the surgery
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) scale.
Time frame: ACLR group: One evaluation with a minimum 2 years follow-up after the surgery
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.
- Individual participant dataSharing planned: Undecided
Related trials for ACL Injury
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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 Injury and Knee Injuries, 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 1 inclusion and 1 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: ACL group: Two evaluations on both injured and healthy knees: 3-4 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?
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.