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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-09-30

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.

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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.

Conditions

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Anterior Cruciate Ligament Rupture

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Ligamys

Intervention Type DEVICE

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.

Interventions

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Ligamys

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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No