Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2016-09-30
2023-06-30
Brief Summary
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The aim of the study is to compare (laxity, instability, and safety) these two types of treatment by using a prospective, randomised multicenter analysis.
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Detailed Description
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Contrary to the classic ligamentoplasty, the treatment with Ligamys consists of promoting heating of the ligament itself by controlling mechanical environment.
It allows a "dynamic" stabilization of the torn Anterior Cruciate Ligament with in the 3 weekly following traumatism. These techniques may improve the recovery process, proprioceptive results, decrease morbidity of transplant harvesting and faster for the patients. It's all these issues we would like to assess with a randomised multicenter study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ligamys technique
Ligamys technique (device) or standard technique
ligamys technique
Ligamys technique (device) or standard technique
standard technique
Ligamys technique (device) or standard technique
standard technique (anatomic reconstruction)
Ligamys technique (device) or standard technique
Interventions
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ligamys technique
Ligamys technique (device) or standard technique
standard technique (anatomic reconstruction)
Ligamys technique (device) or standard technique
Eligibility Criteria
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Inclusion Criteria
* Primary Anterior Cruciate Ligament rupture
* signed patient consent
* surgery 21 days or less after traumatism for Ligamys technique
Exclusion Criteria
* previous osseous disease
* pregnant or nursing woman.
18 Years
35 Years
ALL
No
Sponsors
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Société Mathys SA for sponsoring Ligamys Device
UNKNOWN
University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Stéphane DESCAMPS
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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CHU Clermont-Ferrand
Clermont-Ferrand, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHU 0260
Identifier Type: -
Identifier Source: org_study_id
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