ACL InjuryACLSTIFFNCT05264597
Hamstring Stiffness After Anterior Cruciate Ligament Reconstruction
An observational study of ACL Injury and Stiffness of Knee, Not Elsewhere Classified, run by University Hospital, Caen at 1 site in France.
Trial summary
The role of hamstring has been studied in anterior cruciate ligament (ACL) injury prevention, mainly to counteract the anterior tibial translation , especially when contracting eccentrically, but also with passive stiffness. Read more about this study
- Who is it for?
- Ages 16 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- ACL Injury, Stiffness of Knee, Not Elsewhere Classified, Sport Injury
- How many people
- 135 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2017to 1 Oct 2021
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: ACLR group: All 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 Control group: Age- and sexe- matched healthy volunteers with regular sport practice
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 and 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
- Previous severe injury on the ipsilateral or contralateral knee
- Recent muscle damage
- ACL reinjury ( graft failure)
- Patient with genu flexum, or constant flexed knee at 3 months after surgery
- Informed consent not obtained
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hamstring Stiffness After Anterior Cruciate Ligament Reconstruction: a Prospective Study
The role of hamstring has been studied in anterior cruciate ligament (ACL) injury prevention, mainly to counteract the anterior tibial translation , especially when contracting eccentrically, but also with passive stiffness. However, little is known about the passive hamstring stiffness after ACL reconstruction (ACLR).
The primary objective of this study is to evaluate the passive stiffness of hamstring muscles after ACLR by using an isokinetic device. Secondary, we aimed to test the individual and surgical characteristics associated with hamstring stiffness and the impact of hamstring stiffness on RTS and knee re-injury.
Read more
The hypotheses are that hamstring stiffness will be lower in the ACLR leg compared to the uninjured leg and to healthy individuals.
Also, we hypothesized that hamstring stiffness will be lower after hamstring autograft compared to patellar tendon autograft and will increase progressively after ACLR to be symmetrical at the time for RTS.
Also, we hypothesized that hamstring stiffness could be associated with better outcomes at RTS (RTS at same level and lower re-injury rates)
- Medical subject headings
- Anterior Cruciate Ligament Injuries
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 |
|---|---|---|
| ACLR group | Patients after ACLR with a standardized followup in the Sport Medicine department | |
| Control group | Age and sexe-matches volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in passive hamstring stiffness
Measurement of knee flexors stiffness (in newton.meter per degree, Nm/°) on isokinetic dynamometer.
Measured: ACLR group: Two evaluations on both injured and healthy knees: (1) 4 months after surgery and (2) 8 months after surgery; Control group:one evaluation at a single point in time through study completion (an average of one year)
Change in Strength
Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer.
Measured: ACLR group: Two evaluations on both injured and healthy knees: (1) 4 months after surgery and (2) 8 months after surgery; Control group:one evaluation at a single point in time through study completion (an average of one year)
Secondary outcomes (2)
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; Control group:one evaluation at a single point in time through study completion (an average of one year)
Surgery characteristics
Surgery characteristics recorded in the medical report as the type of surgery, the surgery duration and tourniquet time
Measured: ACLR group only: one follow-up medical consultations at 4 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start1 Jan 2017
- Primary completion1 Feb 2020
- Study completion1 Oct 2021
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.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 135 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
- NCT05264597
- Sponsor's protocol ID
- ACLSTIFF 1452
- Acronym
- ACLSTIFF
- Status last verified
- Feb 2023
- First submitted
- 22 Feb 2022
- 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
- Hamstring Stiffness After Anterior Cruciate Ligament Reconstruction: a Prospective Study
- ClinicalTrials.gov ID
- NCT05264597
- Acronym / sponsor ID
- ACLSTIFF / ACLSTIFF 1452
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 3 Mar 2022 (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 role of hamstring has been studied in anterior cruciate ligament (ACL) injury prevention, mainly to counteract the anterior tibial translation , especially when contracting eccentrically, but also with passive stiffness. However, little is known about the passive hamstring stiffness after ACL reconstruction (ACLR).
The primary objective of this study is to evaluate the passive stiffness of hamstring muscles after ACLR by using an isokinetic device. Secondary, we aimed to test the individual and surgical characteristics associated with hamstring stiffness and the impact of hamstring stiffness on RTS and knee re-injury.
The hypotheses are that hamstring stiffness will be lower in the ACLR leg compared to the uninjured leg and to healthy individuals.
Also, we hypothesized that hamstring stiffness will be lower after hamstring autograft compared to patellar tendon autograft and will increase progressively after ACLR to be symmetrical at the time for RTS.
Also, we hypothesized that hamstring stiffness could be associated with better outcomes at RTS (RTS at same level and lower re-injury rates)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACLR group | – | –Patients after ACLR with a standardized followup in the Sport Medicine department |
| Control group | – | –Age and sexe-matches volunteers |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- ACLR group: All 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 Control group: Age- and sexe- matched healthy volunteers with regular sport practice
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 and 8 mnths after surgery respectively
- Patient who received the information form
Key exclusion criteria (8 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
- Previous severe injury on the ipsilateral or contralateral knee
- Recent muscle damage
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 passive hamstring stiffness
Time frame: ACLR group: Two evaluations on both injured and healthy knees: (1) 4 months after surgery and (2) 8 months after surgery; Control group:one evaluation at a single point in time through study completion (an average of one year)
Measurement of knee flexors stiffness (in newton.meter per degree, Nm/°) on isokinetic dynamometer.
Change in Strength
Time frame: ACLR group: Two evaluations on both injured and healthy knees: (1) 4 months after surgery and (2) 8 months after surgery; Control group:one evaluation at a single point in time through study completion (an average of one year)
Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer.
2 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; Control group:one evaluation at a single point in time through study completion (an average of one year)
Surgery characteristics
Time frame: ACLR group only: one follow-up medical consultations at 4 months after 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
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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 Stiffness of Knee, Not Elsewhere Classified, 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 8 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 passive hamstring stiffness (time frame: ACLR group: Two evaluations on both injured and healthy knees: (1) 4 months after surgery and (2) 8 months after surgery; Control group:one evaluation at a single point in time through study completion (an average of one year)). 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.