Anterior Cruciate Ligament Rupture
Conditions
Keywords
Ligamys, ACL, healing
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.
Interventions
DEVICELigamys
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.
Sponsors
Mathys Ltd Bettlach
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Patient satisfaction, work absence, activity, pain and secondary degenerative changes of the knee joint | 10 years follow-up |
Countries
Belgium, Germany, Switzerland
Outcome results
None listed