Status:
COMPLETED
Induced ACL Healing With the Ligamys Technique: a Prospective, Multicenter Observational Case Series
Lead Sponsor:
Mathys Ltd Bettlach
Conditions:
Anterior Cruciate Ligament Rupture
Eligibility:
All Genders
18-50 years
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 s...
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 osteoarthriti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT02203214
Start Date
August 1 2013
End Date
September 1 2016
Last Update
August 17 2018
Active Locations (3)
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1
UZ Gent
Ghent, Belgium, 9000
2
Universitätsklinikum Münster
Münster, Germany, 48149
3
Sonnenhof
Bern, Switzerland, 3008