Anterior Cruciate Ligament RuptureLigamysNCT02203214
Induced ACL Healing With the Ligamys Technique: a Prospective, Multicenter Observational Case Series
An observational study of Anterior Cruciate Ligament Rupture, run by Mathys Ltd Bettlach at 3 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the Ligamys technique for the treatment of acute ruptures of the anterior cruciate ligament in a multicenter routine clinical setting. To conduct a long-term follow-up of the case series as a post-market product surveillance endeavor. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- Ligamys
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Aug 2013to Sep 2016
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with an acute rupture of the anterior cruciate ligament
Who may be able to join
- Primary rupture of the anterior cruciate ligament
- Signed patient informed consent
- Willingness to present for follow-up
- Age between 18 and 50 years at the time of inclusion in the study
- Injury - surgery time interval of 21 days or less
Who cannot join
- Medical non-compliance
- Unwillingness to follow the rehabilitation programme
- Traumatic cartilage lesion requiring cartilage repair procedure (Microfracturing, MACI, ACT) or degenerative cartilage lesions (Outerbridge >ll and defect >1cm2)
- Non-repairable meniscus lesions requiring a resection of >20%
- Previous tendon removal on injured leg
- Relevant permanent medication (Steroids, cytostatic drugs, ...)
- Pregnancy
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
The purpose of this study is to evaluate the safety and effectiveness of the Ligamys technique for the treatment of acute ruptures of the anterior cruciate ligament in a multicenter routine clinical setting. To conduct a long-term follow-up of the case series as a post-market product surveillance endeavor.
Read the detailed description
The Ligamys method was successfully applied in an animal study including eleven white alpine sheep. Healing of the torn ACL and a stable joint without signs of intra-articular damages or osteoarthritis three months postoperative were observed (Kohl KSSTA 2013). In a first clinical study with ten patients, the Ligamys surgical technique resulted in stable clinical and radiological healing of the torn ACL in nine patients with one re-rupture after four months. Nine patients obtained normal knee scores, reported excellent patient satisfaction, and could return to their previous levels of sporting activity (Kohl Swiss Med Wkly 2011).
The purpose of this study is to evaluate the safety and effectiveness of the Ligamys technique for the treatment of acute ruptures of the anterior cruciate ligament in a multicenter routine clinical setting. To conduct a long-term follow-up of the case series as a post-market product surveillance endeavor.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- Ligamys
- Keywords
- Ligamys, ACL, healing
- 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.
LigamysDevice
All patients are treated with Ligamys within 21 days after injury. The Ligamys implant has to be used in accordance with the instructions for use.
| Study group | Role | What they receive |
|---|---|---|
| Ligamys | All patients treated with Ligamys can be included in the study. Patients must meet all of the inclusion criteria and none of the exclusion criteria to be enrolled. Receives: Device: Ligamys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee stability and function plus safety aspects
Knee stability: Lachman test Knee function: Lysholm score, IKDC score Safety: ACL re-ruptures or instabilities leading to an implant removal
Measured: 12 months follow-up
Secondary outcomes (1)
Patient satisfaction, work absence, activity, pain and secondary degenerative changes of the knee joint
Measured: 10 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startAug 2013
- Primary completionSep 2016
- Study completionSep 2016
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.
- 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
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mathys Ltd Bettlach
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan Eggli, Prof Dr med, Principal investigator, Klinik Sonnenhof, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203214
- Sponsor's protocol ID
- V03_29082013
- Acronym
- Ligamys
- Status last verified
- Aug 2018
- First submitted
- 28 Jul 2014
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induced ACL Healing With the Ligamys Technique: a Prospective, Multicenter Observational Case Series
- ClinicalTrials.gov ID
- NCT02203214
- Acronym / sponsor ID
- Ligamys / V03_29082013
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- Ligamys, ACL, healing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Mathys Ltd BettlachIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 Jul 2014 (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 purpose of this study is to evaluate the safety and effectiveness of the Ligamys technique for the treatment of acute ruptures of the anterior cruciate ligament in a multicenter routine clinical setting. To conduct a long-term follow-up of the case series as a post-market product surveillance endeavor.
Detailed description
The Ligamys method was successfully applied in an animal study including eleven white alpine sheep. Healing of the torn ACL and a stable joint without signs of intra-articular damages or osteoarthritis three months postoperative were observed (Kohl KSSTA 2013). In a first clinical study with ten patients, the Ligamys surgical technique resulted in stable clinical and radiological healing of the torn ACL in nine patients with one re-rupture after four months. Nine patients obtained normal knee scores, reported excellent patient satisfaction, and could return to their previous levels of sporting activity (Kohl Swiss Med Wkly 2011).
The purpose of this study is to evaluate the safety and effectiveness of the Ligamys technique for the treatment of acute ruptures of the anterior cruciate ligament in a multicenter routine clinical setting. To conduct a long-term follow-up of the case series as a post-market product surveillance endeavor.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ligamys | – | Device: LigamysAll patients treated with Ligamys can be included in the study. Patients must meet all of the inclusion criteria and none of the exclusion criteria to be enrolled. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with an acute rupture of the anterior cruciate ligament
Key inclusion criteria (5 listed)
- Primary rupture of the anterior cruciate ligament
- Signed patient informed consent
- Willingness to present for follow-up
- Age between 18 and 50 years at the time of inclusion in the study
- Injury - surgery time interval of 21 days or less
Key exclusion criteria (7 listed)
- Medical non-compliance
- Unwillingness to follow the rehabilitation programme
- Traumatic cartilage lesion requiring cartilage repair procedure (Microfracturing, MACI, ACT) or degenerative cartilage lesions (Outerbridge >ll and defect >1cm2)
- Non-repairable meniscus lesions requiring a resection of >20%
- Previous tendon removal on injured leg
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 |
|---|---|---|
| LigamysAll patients are treated with Ligamys within 21 days after injury. The Ligamys implant has to be used in accordance with the instructions for use. | Device | Ligamys |
Primary outcome
Knee stability and function plus safety aspects
Time frame: 12 months follow-up
Knee stability: Lachman test Knee function: Lysholm score, IKDC score Safety: ACL re-ruptures or instabilities leading to an implant removal
1 secondary outcome
Patient satisfaction, work absence, activity, pain and secondary degenerative changes of the knee joint
Time frame: 10 years follow-up
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 17 Aug 2018.
- Click here for more information about this treatment optionLink provided by the sponsor.
- 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.
Stefan Eggli, Prof Dr med principal investigator
Klinik Sonnenhof, Switzerland
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Rupture, run by Mathys Ltd Bettlach at 3 sites in 3 countries.
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 5 inclusion and 7 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 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Germany, Switzerland. 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?
Knee stability and function plus safety aspects (time frame: 12 months follow-up). 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 17 Aug 2018.