Study Stopped
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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.
1 other identifier
interventional
40
1 country
3
Brief Summary
The investigators will evaluate the benefit of a new bioresorbable screw for repair of anterior cruciate ligament over 3 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2018
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2018
CompletedFirst Posted
Study publicly available on registry
May 18, 2018
CompletedStudy Start
First participant enrolled
September 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2019
CompletedAugust 5, 2020
August 1, 2020
7 months
May 7, 2018
August 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
In situ degradation of screw
Assessed on T1 and proton density fat saturation MRI
Year 3
Secondary Outcomes (65)
Knee stiffness
Day -1
Knee stiffness
Day 0
Knee stiffness
Week 6
Knee stiffness
Month 3
Knee stiffness
Month 8
- +60 more secondary outcomes
Study Arms (1)
Patients with anterior cruciate ligament rupture
EXPERIMENTALInterventions
Placement of an SMS bioresorbable interference screw (DEDIENNE Santé)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Hospitalier Universitaire de Nīmeslead
- Dedienne Sante S.A.S.collaborator
Study Sites (3)
Polyclinique Urbain V
Avignon, 84000, France
Centre Régina
Nice, 06000, France
CHU Nimes
Nîmes, 30029, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philippe Marchand, MD
CHU Nimes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2018
First Posted
May 18, 2018
Study Start
September 17, 2018
Primary Completion
April 24, 2019
Study Completion
April 24, 2019
Last Updated
August 5, 2020
Record last verified: 2020-08