Induced ACL Healing With the Ligamys Technique: a Prospective, Multicenter Observational Case Series

Anterior Cruciate Ligament Rupture Clinical Trial

— Ligamys  

Official title:

Induced ACL Healing With the Ligamys Technique: a Prospective, Multicenter Observational Case Series

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02203214
• Other study ID #: V03_29082013
• Status: Completed
• Start date: August 2013
• Est. completion date: September 2016

Study information

• Verified date: August 2018
• Source: Mathys Ltd Bettlach
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Rupture
• Rupture

Intervention

Device:
• Ligamys
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.

Locations

Country	Name	City	State
Belgium	UZ Gent	Gent
Germany	Universitätsklinikum Münster	Münster
Switzerland	Sonnenhof	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Mathys Ltd Bettlach

Countries where clinical trial is conducted

Belgium,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Patient satisfaction, work absence, activity, pain and secondary degenerative changes of the knee joint		10 years follow-up

External Links

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