Anterior Cruciate Ligament RuptureLIGAMYSNCT02740452
Anterior Cruciate Ligament Rupture
A study testing ligamys technique and standard technique (anatomic reconstruction) in people with Anterior Cruciate Ligament Rupture, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The assess results of Anterior Cruciate Ligament (ACL) repair with the Ligamys® surgical technique versus standard technique. The aim of the study is to compare (laxity, instability, and safety) these two types of treatment by using a prospective, randomised multicenter analysis. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- ligamys technique and standard technique (anatomic reconstruction)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2016to Jun 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 to 35 years
- Primary Anterior Cruciate Ligament rupture
- signed patient consent
- surgery 21 days or less after traumatism for Ligamys technique
Who cannot join
- infection of the operating site
- previous osseous disease
- pregnant or nursing woman.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Stephane DESCAMPS
About this study
Official title: Ligamys Technique Versus Standard Technique for the Anterior Cruciate Ligament Rupture
The assess results of Anterior Cruciate Ligament (ACL) repair with the Ligamys® surgical technique versus standard technique.
The aim of the study is to compare (laxity, instability, and safety) these two types of treatment by using a prospective, randomised multicenter analysis.
Read the detailed description
The treatment of acute ruptures of the anterior cruciate ligament is surgical in some cases with ligamentoplasty technique.
Contrary to the classic ligamentoplasty, the treatment with Ligamys consists of promoting heating of the ligament itself by controlling mechanical environment.
It allows a "dynamic" stabilization of the torn Anterior Cruciate Ligament with in the 3 weekly following traumatism. These techniques may improve the recovery process, proprioceptive results, decrease morbidity of transplant harvesting and faster for the patients. It's all these issues we would like to assess with a randomised multicenter study.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- ligamys technique, standard technique (anatomic reconstruction)
- Keywords
- Rupture, Anterior Cruciate Ligament (ACL), Laxity knee, Instability knee
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ligamys techniqueDevice
Ligamys technique (device) or standard technique
standard technique (anatomic reconstruction)Other
Ligamys technique (device) or standard technique
| Study group | Role | What they receive |
|---|---|---|
| Ligamys technique | Other | Ligamys technique (device) or standard technique Receives: Device: ligamys technique |
| standard technique | Other | Ligamys technique (device) or standard technique Receives: Other: standard technique (anatomic reconstruction) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring anterior knee laxity with KT 1000 arthrometer
Measured: at 12 months
Secondary outcomes (3)
Tegnér scores
Measured: at 12 months
Lysholm scores
Measured: at 12 months
IKDC score safety
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Société Mathys SA for sponsoring Ligamys Device
- Responsible party
- Sponsor
- Investigators
- Stéphane DESCAMPS, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740452
- Sponsor's protocol ID
- CHU 0260
- Acronym
- LIGAMYS
- Status last verified
- Jun 2021
- First submitted
- 25 Mar 2016
- Last updated
- 15 Mar 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ligamys Technique Versus Standard Technique for the Anterior Cruciate Ligament Rupture
- ClinicalTrials.gov ID
- NCT02740452
- Acronym / sponsor ID
- LIGAMYS / CHU 0260
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- Rupture, Anterior Cruciate Ligament (ACL), Laxity knee, Instability knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Société Mathys SA for sponsoring Ligamys Device
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 15 Apr 2016 (estimated)
- 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 assess results of Anterior Cruciate Ligament (ACL) repair with the Ligamys® surgical technique versus standard technique.
The aim of the study is to compare (laxity, instability, and safety) these two types of treatment by using a prospective, randomised multicenter analysis.
Detailed description
The treatment of acute ruptures of the anterior cruciate ligament is surgical in some cases with ligamentoplasty technique.
Contrary to the classic ligamentoplasty, the treatment with Ligamys consists of promoting heating of the ligament itself by controlling mechanical environment.
It allows a "dynamic" stabilization of the torn Anterior Cruciate Ligament with in the 3 weekly following traumatism. These techniques may improve the recovery process, proprioceptive results, decrease morbidity of transplant harvesting and faster for the patients. It's all these issues we would like to assess with a randomised multicenter study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ligamys technique | Other | Device: ligamys techniqueLigamys technique (device) or standard technique |
| standard technique | Other | Other: standard technique (anatomic reconstruction)Ligamys technique (device) or standard technique |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 to 35 years
- Primary Anterior Cruciate Ligament rupture
- signed patient consent
- surgery 21 days or less after traumatism for Ligamys technique
Key exclusion criteria (3 listed)
- infection of the operating site
- previous osseous disease
- pregnant or nursing woman.
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 |
|---|---|---|
| ligamys techniqueLigamys technique (device) or standard technique | Device | Ligamys technique |
| standard technique (anatomic reconstruction)Ligamys technique (device) or standard technique | Other | standard technique |
Primary outcome
Measuring anterior knee laxity with KT 1000 arthrometer
Time frame: at 12 months
3 secondary outcomes
Tegnér scores
Time frame: at 12 months
Lysholm scores
Time frame: at 12 months
IKDC score safety
Time frame: at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
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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.
Stéphane DESCAMPS principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ligamys technique and standard technique (anatomic reconstruction) in people with Anterior Cruciate Ligament Rupture, run by University Hospital, Clermont-Ferrand 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 4 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 15 Mar 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?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring anterior knee laxity with KT 1000 arthrometer (time frame: at 12 months). 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 15 Mar 2022.