Clinical trial NCT02203214: Induced ACL Healing With the Ligamys Technique: a Prospective, Multicenter Observational Case Series
Official title: Induced ACL Healing With the Ligamys Technique: a Prospective, Multicenter Observational Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anterior Cruciate Ligament Rupture
Keywords: Ligamys
ACL
healing
Lead sponsor: Mathys Ltd Bettlach
Sponsor class: INDUSTRY
First posted: 2014-07-29
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an acute rupture of the anterior cruciate ligament

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knee stability and function plus safety aspects
timeFrame: 12 months follow-up
Secondary outcomes:
measure: Patient satisfaction, work absence, activity, pain and secondary degenerative changes of the knee joint
timeFrame: 10 years follow-up
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: UZ Gent
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Bern
country: Switzerland
facility: Sonnenhof
Study officials:
affiliation: Klinik Sonnenhof, Switzerland
name: Stefan Eggli, Prof Dr med
role: PRINCIPAL_INVESTIGATOR
References: