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

Completed

• Conditions: Anterior Cruciate Ligament Rupture
• Interventions: Device: Ligamys

• Registration Number: NCT02203214
• Lead Sponsor: Mathys Ltd Bettlach

Brief 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.

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 Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-07-28
• Study First Submitted QC: 2014-07-28
• Study First Posted: 2014-07-29
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-16
• Last Update Posted: 2018-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ligamys	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.

Primary Outcome Measures

Name	Time	Method
Knee stability and function plus safety aspects	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

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction, work absence, activity, pain and secondary degenerative changes of the knee joint	10 years follow-up

Trial Locations

Locations (3)

UZ Gent; 🇧🇪 Gent, Belgium

Sonnenhof; 🇨🇭 Bern, Switzerland

Universitätsklinikum Münster; 🇩🇪 Münster, Germany