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. (BIORELICA)

Centre Hospitalier Universitaire de Nīmes

Status: Terminated

Conditions: Anterior Cruciate Ligament Rupture

Treatments: Procedure: Anterior Cruciate Ligament Reconstruction

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03529552

IDIL/2017/PM-01

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Patients with anterior cruciate ligament rupture

Experimental group

Treatment:

Procedure: Anterior Cruciate Ligament Reconstruction