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)

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.

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

Study Overview

• Status: Terminated
• Conditions: Anterior Cruciate Ligament Rupture
• Intervention / Treatment: Procedure: Anterior Cruciate Ligament Reconstruction

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Avignon, France, 84000
    • Polyclinique Urbain V
  • Nice, France, 06000
    • Centre Régina
  • Nîmes, France, 30029
    • CHU Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Collaborators: Dedienne Sante S.A.S.
• Investigators: Principal Investigator: Philippe Marchand, MD, CHU Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2018
• Primary Completion (Actual): April 24, 2019
• Study Completion (Actual): April 24, 2019

Study Registration Dates

• First Submitted: May 7, 2018
• First Submitted That Met QC Criteria: May 17, 2018
• First Posted (Actual): May 18, 2018

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Rupture; Postoperative Complications
• Other Study ID Numbers: IDIL/2017/PM-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No