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.

Centre Hospitalier Universitaire de Nīmes40 enrolled

Overview

The investigators will evaluate the benefit of a new bioresorbable screw for repair of anterior cruciate ligament over 3 years.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anterior Cruciate Ligament Rupture

Interventions

Anterior Cruciate Ligament ReconstructionPROCEDURE

Placement of an SMS bioresorbable interference screw (DEDIENNE Santé)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The patient must have given their free and informed consent and signed the consent form * 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 is participating in an interventional study, or is in a period of exclusion determined by a previous study * 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

Locations (3)

Polyclinique Urbain V

Avignon, France

Centre Régina

Nice, France

CHU Nimes

Nîmes, France

Outcomes

Primary Outcomes

In situ degradation of screw

Assessed on T1 and proton density fat saturation MRI

Time frame: Year 3

Secondary Outcomes

Knee stiffness

Articular amplitude test

Time frame: Day -1

Knee stiffness

Articular amplitude test

Time frame: Day 0

Knee stiffness

Articular amplitude test

Time frame: Week 6

Knee stiffness

Articular amplitude test

Time frame: Month 3

Knee stiffness

Articular amplitude test

Time frame: Month 8

Knee stiffness

Articular amplitude test

Time frame: Year 1

Knee stiffness

Articular amplitude test

Time frame: Year 2

Knee stiffness

Articular amplitude test

Time frame: Year 3

Knee mobility

Anterior pull test

Time frame: Day -1

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.