Clinical trial NCT03529552: 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.
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: Dedienne Sante S.A.S.
First posted: 2018-05-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: In situ degradation of screw
timeFrame: Year 3
Secondary outcomes:
measure: Knee stiffness
timeFrame: Day -1
measure: Knee stiffness
timeFrame: Day 0
measure: Knee stiffness
timeFrame: Week 6
measure: Knee stiffness
timeFrame: Month 3
measure: Knee stiffness
timeFrame: Month 8
measure: Knee stiffness
timeFrame: Year 1
measure: Knee stiffness
timeFrame: Year 2
measure: Knee stiffness
timeFrame: Year 3
measure: Knee mobility
timeFrame: Day -1
measure: Knee mobility
timeFrame: Day 0
measure: Knee mobility
timeFrame: Week 6
measure: Knee mobility
timeFrame: Month 3
measure: Knee mobility
timeFrame: Month 8
measure: Knee mobility
timeFrame: Year 1
measure: Knee mobility
timeFrame: Year 2
measure: Knee mobility
timeFrame: Year 3
measure: Lateral pivot shift of knee
timeFrame: Day -1
measure: Lateral pivot shift of knee
timeFrame: Day 0
measure: Lateral pivot shift of knee
timeFrame: Week 6
measure: Lateral pivot shift of knee
timeFrame: Month 3
measure: Lateral pivot shift of knee
timeFrame: Month 8
measure: Lateral pivot shift of knee
timeFrame: Year 1
measure: Lateral pivot shift of knee
timeFrame: Year 2
measure: Lateral pivot shift of knee
timeFrame: Year 3
measure: Impact of knee pain on daily life
timeFrame: Day -1
measure: Impact of knee pain on daily life
timeFrame: Day 0
measure: Impact of knee pain on daily life
timeFrame: Week 6
measure: Impact of knee pain on daily life
timeFrame: Month 3
measure: Impact of knee pain on daily life
timeFrame: Month 8
measure: Impact of knee pain on daily life
timeFrame: year 1
measure: Impact of knee pain on daily life
timeFrame: Year 2
measure: Impact of knee pain on daily life
timeFrame: Year 3
measure: Patient-reported knee problems
timeFrame: Day -1
measure: Patient-reported knee problems
timeFrame: Day 0
measure: Patient-reported knee problems
timeFrame: Week 6
measure: Patient-reported knee problems
timeFrame: Month 3
measure: Patient-reported knee problems
timeFrame: Month 8
measure: Patient-reported knee problems
timeFrame: Year 1
measure: Patient-reported knee problems
timeFrame: Year 2
measure: Patient-reported knee problems
timeFrame: Year 3
measure: Knee laxity
timeFrame: Day -1
measure: Knee laxity
timeFrame: Day 0
measure: Knee laxity
timeFrame: Week 6
measure: Knee laxity
timeFrame: Month 3
measure: Knee laxity
timeFrame: Month 8
measure: Knee laxity
timeFrame: Year 1
measure: Knee laxity
timeFrame: Year 2
measure: Knee laxity
timeFrame: Year 3
measure: Passive accessory movement of knee
timeFrame: Day -1
measure: Passive accessory movement of knee
timeFrame: Day 0
measure: Passive accessory movement of knee
timeFrame: Week 6
measure: Passive accessory movement of knee
timeFrame: Month 3
measure: Passive accessory movement of knee
timeFrame: Month 8
measure: Passive accessory movement of knee
timeFrame: Year 1
measure: Passive accessory movement of knee
timeFrame: Year 2
measure: Passive accessory movement of knee
timeFrame: Year 3
measure: Anterior cruciate ligament and posterior capsule integrity
timeFrame: Day -1
measure: Anterior cruciate ligament and posterior capsule integrity
timeFrame: Day 0
measure: Anterior cruciate ligament and posterior capsule integrity
timeFrame: Week 6
measure: Anterior cruciate ligament and posterior capsule integrity
timeFrame: Month 3
measure: Anterior cruciate ligament and posterior capsule integrity
timeFrame: Month 8
measure: Anterior cruciate ligament and posterior capsule integrity
timeFrame: Year 1
measure: Anterior cruciate ligament and posterior capsule integrity
timeFrame: Year 2
measure: Anterior cruciate ligament and posterior capsule integrity
timeFrame: Year 3
measure: Post-operative complications
timeFrame: Year 3
Other outcomes:
Locations:
city: Avignon
country: France
facility: Polyclinique Urbain V
city: Nice
country: France
facility: Centre Régina
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
affiliation: CHU Nimes
name: Philippe Marchand, MD
role: PRINCIPAL_INVESTIGATOR
References: