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.

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

Official Title
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Short-, Medium- and Long-term (up to 3 Years) 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.

Conditions
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Anterior Cruciate Ligament Rupture

Intervention / Treatment
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* Procedure: Anterior Cruciate Ligament Reconstruction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with anterior cruciate ligament rupture<br> | Procedure: Anterior Cruciate Ligament Reconstruction<br>* Placement of an SMS bioresorbable interference screw (DEDIENNE Santé)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In situ degradation of screw | Assessed on T1 and proton density fat saturation MRI | Year 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee stiffness | Articular amplitude test | Day -1 | 
| Knee stiffness | Articular amplitude test | Day 0 | 
| Knee stiffness | Articular amplitude test | Week 6 | 
| Knee stiffness | Articular amplitude test | Month 3 | 
| Knee stiffness | Articular amplitude test | Month 8 | 
| Knee stiffness | Articular amplitude test | Year 1 | 
| Knee stiffness | Articular amplitude test | Year 2 | 
| Knee stiffness | Articular amplitude test | Year 3 | 
| Knee mobility | Anterior pull test | Day -1 | 
| Knee mobility | Anterior pull test | Day 0 | 
| Knee mobility | Anterior pull test | Week 6 | 
| Knee mobility | Anterior pull test | Month 3 | 
| Knee mobility | Anterior pull test | Month 8 | 
| Knee mobility | Anterior pull test | Year 1 | 
| Knee mobility | Anterior pull test | Year 2 | 
| Knee mobility | Anterior pull test | Year 3 | 
| Lateral pivot shift of knee | MacIntosh test | Day -1 | 
| Lateral pivot shift of knee | MacIntosh test | Day 0 | 
| Lateral pivot shift of knee | MacIntosh test | Week 6 | 
| Lateral pivot shift of knee | MacIntosh test | Month 3 | 
| Lateral pivot shift of knee | MacIntosh test | Month 8 | 
| Lateral pivot shift of knee | MacIntosh test | Year 1 | 
| Lateral pivot shift of knee | MacIntosh test | Year 2 | 
| Lateral pivot shift of knee | MacIntosh test | Year 3 | 
| Impact of knee pain on daily life | Lysholm Knee Scoring Scale | Day -1 | 
| Impact of knee pain on daily life | Lysholm Knee Scoring Scale | Day 0 | 
| Impact of knee pain on daily life | Lysholm Knee Scoring Scale | Week 6 | 
| Impact of knee pain on daily life | Lysholm Knee Scoring Scale | Month 3 | 
| Impact of knee pain on daily life | Lysholm Knee Scoring Scale | Month 8 | 
| Impact of knee pain on daily life | Lysholm Knee Scoring Scale | year 1 | 
| Impact of knee pain on daily life | Lysholm Knee Scoring Scale | Year 2 | 
| Impact of knee pain on daily life | Lysholm Knee Scoring Scale | Year 3 | 
| Patient-reported knee problems | International Knee Documentation Committee Questionnaire | Day -1 | 
| Patient-reported knee problems | International Knee Documentation Committee Questionnaire | Day 0 | 
| Patient-reported knee problems | International Knee Documentation Committee Questionnaire | Week 6 | 
| Patient-reported knee problems | International Knee Documentation Committee Questionnaire | Month 3 | 
| Patient-reported knee problems | International Knee Documentation Committee Questionnaire | Month 8 | 
| Patient-reported knee problems | International Knee Documentation Committee Questionnaire | Year 1 | 
| Patient-reported knee problems | International Knee Documentation Committee Questionnaire | Year 2 | 
| Patient-reported knee problems | International Knee Documentation Committee Questionnaire | Year 3 | 
| Knee laxity | KT-1000 measurement | Day -1 | 
| Knee laxity | KT-1000 measurement | Day 0 | 
| Knee laxity | KT-1000 measurement | Week 6 | 
| Knee laxity | KT-1000 measurement | Month 3 | 
| Knee laxity | KT-1000 measurement | Month 8 | 
| Knee laxity | KT-1000 measurement | Year 1 | 
| Knee laxity | KT-1000 measurement | Year 2 | 
| Knee laxity | KT-1000 measurement | Year 3 | 
| Passive accessory movement of knee | Lachman test | Day -1 | 
| Passive accessory movement of knee | Lachman test | Day 0 | 
| Passive accessory movement of knee | Lachman test | Week 6 | 
| Passive accessory movement of knee | Lachman test | Month 3 | 
| Passive accessory movement of knee | Lachman test | Month 8 | 
| Passive accessory movement of knee | Lachman test | Year 1 | 
| Passive accessory movement of knee | Lachman test | Year 2 | 
| Passive accessory movement of knee | Lachman test | Year 3 | 
| Anterior cruciate ligament and posterior capsule integrity | Pivot-shift test | Day -1 | 
| Anterior cruciate ligament and posterior capsule integrity | Pivot-shift test | Day 0 | 
| Anterior cruciate ligament and posterior capsule integrity | Pivot-shift test | Week 6 | 
| Anterior cruciate ligament and posterior capsule integrity | Pivot-shift test | Month 3 | 
| Anterior cruciate ligament and posterior capsule integrity | Pivot-shift test | Month 8 | 
| Anterior cruciate ligament and posterior capsule integrity | Pivot-shift test | Year 1 | 
| Anterior cruciate ligament and posterior capsule integrity | Pivot-shift test | Year 2 | 
| Anterior cruciate ligament and posterior capsule integrity | Pivot-shift test | Year 3 | 
| Post-operative complications | Undesirable events | Year 3 |