Induced ACL Healing With the Ligamys Technique: a Prospective, Multicenter Observational Case Series (Ligamys)
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|ClinicalTrials.gov Identifier: NCT02203214|
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : August 17, 2018
|Condition or disease||Intervention/treatment|
|Anterior Cruciate Ligament Rupture||Device: Ligamys|
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 Type :||Observational|
|Actual Enrollment :||110 participants|
|Official Title:||Induced ACL Healing With the Ligamys Technique: a Prospective, Multicenter Observational Case Series|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
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.
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.
- 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
- Patient satisfaction, work absence, activity, pain and secondary degenerative changes of the knee joint [ Time Frame: 10 years follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203214
|Gent, Belgium, 9000|
|Münster, Germany, 48149|
|Bern, Switzerland, 3008|
|Principal Investigator:||Stefan Eggli, Prof Dr med||Klinik Sonnenhof, Switzerland|