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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ligamys | 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. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction, work absence, activity, pain and secondary degenerative changes of the knee joint | 10 years follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with an acute rupture of the anterior cruciate ligament
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Eggli, Prof Dr med | Klinik Sonnenhof, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Gent | Ghent | 9000 | Belgium | |||
| Universitätsklinikum Münster |
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| Label | URL |
|---|---|
| Click here for more information about this treatment option | View source |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| Münster |
| 48149 |
| Germany |
| Sonnenhof | Bern | 3008 | Switzerland |