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.

Not Applicable

Terminated

• Conditions: Anterior Cruciate Ligament Rupture

• Registration Number: NCT03529552
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2018-05-17
• Study First Posted: 2018-05-18
• Study Start: 2018-09-17
• Primary Completion: 2019-04-24
• Study Completion: 2019-04-24
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
In situ degradation of screw	Year 3	Assessed on T1 and proton density fat saturation MRI

Secondary Outcome Measures

Name	Time	Method
Passive accessory movement of knee	Year 3	Lachman test
Knee mobility	Year 3	Anterior pull test
Patient-reported knee problems	Year 3	International Knee Documentation Committee Questionnaire
Anterior cruciate ligament and posterior capsule integrity	Year 3	Pivot-shift test
Post-operative complications	Year 3	Undesirable events
Lateral pivot shift of knee	Year 3	MacIntosh test
Impact of knee pain on daily life	Year 3	Lysholm Knee Scoring Scale
Knee laxity	Year 3	KT-1000 measurement
Knee stiffness	Year 3	Articular amplitude test

Trial Locations

Locations (3)

Polyclinique Urbain V; 🇫🇷 Avignon, France

Centre Régina; 🇫🇷 Nice, France

CHU Nimes; 🇫🇷 Nîmes, France