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.

Anterior Cruciate Ligament Rupture Clinical Trial

— BIORELICA  

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03529552
• Other study ID #: IDIL/2017/PM-01
• Status: Terminated
• Phase: N/A
• Start date: September 17, 2018
• Est. completion date: April 24, 2019

Study information

• Verified date: August 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: April 24, 2019
• Est. primary completion date: April 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Rupture
• Postoperative Complications
• Rupture

Intervention

Procedure:
• Anterior Cruciate Ligament Reconstruction
Placement of an SMS bioresorbable interference screw (DEDIENNE Santé)

Locations

Country	Name	City	State
France	Polyclinique Urbain V	Avignon
France	Centre Régina	Nice
France	CHU Nimes	Nîmes

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes	Dedienne Sante S.A.S.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In situ degradation of screw	Assessed on T1 and proton density fat saturation MRI	Year 3
Secondary	Knee stiffness	Articular amplitude test	Day -1
Secondary	Knee stiffness	Articular amplitude test	Day 0
Secondary	Knee stiffness	Articular amplitude test	Week 6
Secondary	Knee stiffness	Articular amplitude test	Month 3
Secondary	Knee stiffness	Articular amplitude test	Month 8
Secondary	Knee stiffness	Articular amplitude test	Year 1
Secondary	Knee stiffness	Articular amplitude test	Year 2
Secondary	Knee stiffness	Articular amplitude test	Year 3
Secondary	Knee mobility	Anterior pull test	Day -1
Secondary	Knee mobility	Anterior pull test	Day 0
Secondary	Knee mobility	Anterior pull test	Week 6
Secondary	Knee mobility	Anterior pull test	Month 3
Secondary	Knee mobility	Anterior pull test	Month 8
Secondary	Knee mobility	Anterior pull test	Year 1
Secondary	Knee mobility	Anterior pull test	Year 2
Secondary	Knee mobility	Anterior pull test	Year 3
Secondary	Lateral pivot shift of knee	MacIntosh test	Day -1
Secondary	Lateral pivot shift of knee	MacIntosh test	Day 0
Secondary	Lateral pivot shift of knee	MacIntosh test	Week 6
Secondary	Lateral pivot shift of knee	MacIntosh test	Month 3
Secondary	Lateral pivot shift of knee	MacIntosh test	Month 8
Secondary	Lateral pivot shift of knee	MacIntosh test	Year 1
Secondary	Lateral pivot shift of knee	MacIntosh test	Year 2
Secondary	Lateral pivot shift of knee	MacIntosh test	Year 3
Secondary	Impact of knee pain on daily life	Lysholm Knee Scoring Scale	Day -1
Secondary	Impact of knee pain on daily life	Lysholm Knee Scoring Scale	Day 0
Secondary	Impact of knee pain on daily life	Lysholm Knee Scoring Scale	Week 6
Secondary	Impact of knee pain on daily life	Lysholm Knee Scoring Scale	Month 3
Secondary	Impact of knee pain on daily life	Lysholm Knee Scoring Scale	Month 8
Secondary	Impact of knee pain on daily life	Lysholm Knee Scoring Scale	year 1
Secondary	Impact of knee pain on daily life	Lysholm Knee Scoring Scale	Year 2
Secondary	Impact of knee pain on daily life	Lysholm Knee Scoring Scale	Year 3
Secondary	Patient-reported knee problems	International Knee Documentation Committee Questionnaire	Day -1
Secondary	Patient-reported knee problems	International Knee Documentation Committee Questionnaire	Day 0
Secondary	Patient-reported knee problems	International Knee Documentation Committee Questionnaire	Week 6
Secondary	Patient-reported knee problems	International Knee Documentation Committee Questionnaire	Month 3
Secondary	Patient-reported knee problems	International Knee Documentation Committee Questionnaire	Month 8
Secondary	Patient-reported knee problems	International Knee Documentation Committee Questionnaire	Year 1
Secondary	Patient-reported knee problems	International Knee Documentation Committee Questionnaire	Year 2
Secondary	Patient-reported knee problems	International Knee Documentation Committee Questionnaire	Year 3
Secondary	Knee laxity	KT-1000 measurement	Day -1
Secondary	Knee laxity	KT-1000 measurement	Day 0
Secondary	Knee laxity	KT-1000 measurement	Week 6
Secondary	Knee laxity	KT-1000 measurement	Month 3
Secondary	Knee laxity	KT-1000 measurement	Month 8
Secondary	Knee laxity	KT-1000 measurement	Year 1
Secondary	Knee laxity	KT-1000 measurement	Year 2
Secondary	Knee laxity	KT-1000 measurement	Year 3
Secondary	Passive accessory movement of knee	Lachman test	Day -1
Secondary	Passive accessory movement of knee	Lachman test	Day 0
Secondary	Passive accessory movement of knee	Lachman test	Week 6
Secondary	Passive accessory movement of knee	Lachman test	Month 3
Secondary	Passive accessory movement of knee	Lachman test	Month 8
Secondary	Passive accessory movement of knee	Lachman test	Year 1
Secondary	Passive accessory movement of knee	Lachman test	Year 2
Secondary	Passive accessory movement of knee	Lachman test	Year 3
Secondary	Anterior cruciate ligament and posterior capsule integrity	Pivot-shift test	Day -1
Secondary	Anterior cruciate ligament and posterior capsule integrity	Pivot-shift test	Day 0
Secondary	Anterior cruciate ligament and posterior capsule integrity	Pivot-shift test	Week 6
Secondary	Anterior cruciate ligament and posterior capsule integrity	Pivot-shift test	Month 3
Secondary	Anterior cruciate ligament and posterior capsule integrity	Pivot-shift test	Month 8
Secondary	Anterior cruciate ligament and posterior capsule integrity	Pivot-shift test	Year 1
Secondary	Anterior cruciate ligament and posterior capsule integrity	Pivot-shift test	Year 2
Secondary	Anterior cruciate ligament and posterior capsule integrity	Pivot-shift test	Year 3
Secondary	Post-operative complications	Undesirable events	Year 3