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LIBRE (Ligamys, Internal Bracing, REconstruction) Study: Comparing Three Surgery Techniques After an Acute ACL Rupture.

NCT03441295 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2024-05-16

No results posted yet for this study

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.

Conditions

  • Anterior Cruciate Ligament Rupture

Interventions

PROCEDURE

Dynamic Intraligamentary Stabilization

DIS, Ligamys

PROCEDURE

Internal Brace Ligament Augmentation

IBLA

PROCEDURE

ACL Reconstruction

Conventional

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    collaborator OTHER

  • Onze Lieve Vrouw Hospital

    collaborator OTHER

  • University Hospital, Antwerp

    lead OTHER

Principal Investigators

  • Christiaan Heusdens · UH, Antwerp

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-15
Primary Completion
2024-01-15
Completion
2025-08-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03441295 on ClinicalTrials.gov