Induced ACL Healing With the Ligamys Technique: a Prospective, Multicenter Observational Case Series

Study Overview
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Brief Summary
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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
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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.

Official Title
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Induced ACL Healing With the Ligamys Technique: a Prospective, Multicenter Observational Case Series

Conditions
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Anterior Cruciate Ligament Rupture

Intervention / Treatment
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* Device: Ligamys


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ligamys<br>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. | Device: Ligamys<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction, work absence, activity, pain and secondary degenerative changes of the knee joint |  | 10 years follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ligamys, ACL, healing