Status:
COMPLETED
Performance and Safety of the Composite Interference Screw Used in Anterior Cruciate Ligament Reconstructions
Lead Sponsor:
Biomatlante
Collaborating Sponsors:
Atlanstat
Conditions:
Knee Ligament Injury
Eligibility:
All Genders
18-60 years
Brief Summary
The evaluation of the clinical data has demonstrated the conformity of the Composite Interference Screw (CIS), with the relevant essential requirements for its use in orthopaedic applications. The Com...
Eligibility Criteria
Inclusion
- Acute or chronic ACL deficiency with complete or partial lesion of the anteromedial bundle requiring primary reconstruction of the Anterior Cruciate Ligament with hamstring tendons
- Males or females aged froù 18 to 60 years
- No history of surgery on the affected knee
- Patients not under guardianship or judicial protection
- Signature of non opposition form (consent of the patient
Exclusion
- History of ligament, meniscal surgery or fracture of the affected knee
- Pregnancy of breastfeeding women
Key Trial Info
Start Date :
August 23 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 15 2021
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04076956
Start Date
August 23 2019
End Date
June 15 2021
Last Update
February 4 2025
Active Locations (1)
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1
Clinique JUGE
Marseille, PACA, France, 13008