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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

110

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Aug 2013

Typical duration for all trials

Geographic Reach

3 countries

3 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.1 years study duration

Study Start

First participant enrolled

August 1, 2013

Completed

12 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2014

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2014

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed

Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

3.1 years

First QC Date

July 28, 2014

Last Update Submit

August 16, 2018

Conditions

Anterior Cruciate Ligament Rupture

Keywords

LigamysACLhealing

Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

Patient satisfaction, work absence, activity, pain and secondary degenerative changes of the knee joint
10 years follow-up

Study Arms (1)

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

Interventions

LigamysDEVICE

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.

Ligamys

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

Sampling MethodNon-Probability Sample

Study Population

Patients with an acute rupture of the anterior cruciate ligament

You may qualify if:

Primary rupture of the anterior cruciate ligament
Signed patient informed consent
Willingness to present for follow-up
Injury - surgery time interval of 21 days or less

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Mathys Ltd Bettlachlead

Study Sites (3)

UZ Gent

Ghent, 9000, Belgium

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Sonnenhof

Bern, 3008, Switzerland

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

Stefan Eggli, Prof Dr med
Klinik Sonnenhof, Switzerland
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 28, 2014

First Posted

July 29, 2014

Study Start

August 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

August 17, 2018

Record last verified: 2018-08

Locations

BE(1)CH(1)DE(1)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Ligamys

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Ligamys

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations