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

Mathys

Status: Completed

Conditions: Anterior Cruciate Ligament Rupture

Treatments: Device: Ligamys

Study type: Observational

Funder types: Industry

Identifiers

NCT02203214

V03_29082013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

110 participants in 1 patient group

Ligamys

Description:

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.

Treatment:

Device: Ligamys