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

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ClinicalTrials.gov Identifier: NCT02203214
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Mathys Ltd Bettlach

Study Description
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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.

Condition or disease Intervention/treatment
Anterior Cruciate Ligament Rupture Device: Ligamys

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.

Study Design
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Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Induced ACL Healing With the Ligamys Technique: a Prospective, Multicenter Observational Case Series
Study Start Date : August 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016
Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Knee stability and function plus safety aspects [ Time Frame: 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 Outcome Measures :
  1. Patient satisfaction, work absence, activity, pain and secondary degenerative changes of the knee joint [ Time Frame: 10 years follow-up ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with an acute rupture of the anterior cruciate ligament
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203214


Locations
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Belgium
UZ Gent
Gent, Belgium, 9000
Germany
Universitätsklinikum Münster
Münster, Germany, 48149
Switzerland
Sonnenhof
Bern, Switzerland, 3008
Sponsors and Collaborators
Mathys Ltd Bettlach
Investigators
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Principal Investigator: Stefan Eggli, Prof Dr med Klinik Sonnenhof, Switzerland
More Information
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Additional Information:

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Responsible Party: Mathys Ltd Bettlach
ClinicalTrials.gov Identifier: NCT02203214    
Other Study ID Numbers: V03_29082013
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Mathys Ltd Bettlach:
Ligamys
ACL
healing
Additional relevant MeSH terms:
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Rupture
Wounds and Injuries