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LIBRE (Ligamys, Internal Bracing, REconstruction) Study: Comparing Three Surgery Techniques After an Acute ACL Rupture.
Sponsor: University Hospital, Antwerp
Summary
Single-blind, multi-centre, prospective, randomized controlled trial comparing Ligamys Anterior Cruciate Ligament (ACL) repair, Internal Bracing ACL repair and conventional ACL reconstruction for relative clinical efficacy and economic benefit. Patients with a primary proximal acute ACL rupture will be included in either study 1 (0-4 weeks post rupture) or study 2 (5-12 weeks post rupture) of the LIBRE study.
Official title: Single-blind, Multi-centre, Randomized Controlled Trial Comparing Ligamys Anterior Cruciate Ligament (ACL) Repair, Internal Bracing ACL Repair and Conventional ACL Reconstruction for Relative Clinical Efficacy and Economic Benefit.
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
95
Start Date
2018-02-15
Completion Date
2025-08-30
Last Updated
2024-05-16
Healthy Volunteers
No
Conditions
Interventions
Dynamic Intraligamentary Stabilization
DIS, Ligamys
Internal Brace Ligament Augmentation
IBLA
ACL Reconstruction
Conventional
Locations (3)
University Hospital, Antwerp
Edegem, Antwerp, Belgium
University Hospital, Brussels
Jette, Brussels Capital, Belgium
OLV Hospital
Aalst, Oost-Vlaanderen, Belgium