Evaluation After Reconstruction of the Anterior Cruciate Ligament of the Knee Using the Bioresorbable Interference Screw (SMS): Resorbability, Per- and Post-operative Complications and Articular Functional Recovery.
NCT ID: NCT03529552
Last Updated: 2020-08-05
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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TERMINATED
NA
40 participants
INTERVENTIONAL
2018-09-17
2019-04-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients with anterior cruciate ligament rupture
Anterior Cruciate Ligament Reconstruction
Placement of an SMS bioresorbable interference screw (DEDIENNE Santé)
Interventions
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Anterior Cruciate Ligament Reconstruction
Placement of an SMS bioresorbable interference screw (DEDIENNE Santé)
Eligibility Criteria
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Inclusion Criteria
* The patient must be a member or beneficiary of a health insurance plan
* The patient is at least 18 years old
* The patient is available for at least 3 years of follow-up
* The patient requires ligamentoplasty pour rupture of anterior cruciate ligament confirmed by MRI with or without meniscal lesions as scheduled surgery
Exclusion Criteria
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* The patient is pregnant or breast-feeding
* The patient has a contra-indication (or a medically-incompatible association) for the treatment, including MRI
* Revision surgery
* Simultaneous surgery
18 Years
ALL
No
Sponsors
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Dedienne Sante S.A.S.
INDUSTRY
Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Principal Investigators
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Philippe Marchand, MD
Role: PRINCIPAL_INVESTIGATOR
CHU Nimes
Locations
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Polyclinique Urbain V
Avignon, , France
Centre Régina
Nice, , France
CHU Nimes
Nîmes, , France
Countries
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Other Identifiers
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IDIL/2017/PM-01
Identifier Type: -
Identifier Source: org_study_id
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