Status:
ACTIVE_NOT_RECRUITING
LIBRE (Ligamys, Internal Bracing, REconstruction) Study: Comparing Three Surgery Techniques After an Acute ACL Rupture.
Lead Sponsor:
University Hospital, Antwerp
Collaborating Sponsors:
Universitair Ziekenhuis Brussel
Onze Lieve Vrouw Hospital
Conditions:
Anterior Cruciate Ligament Rupture
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief 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 rela...
Detailed Description
Rationale The conventional operative treatment of an anterior cruciate ligament (ACL) rupture is an ACL reconstruction, whereby the residual ruptured ACL is removed and replaced by an autograft hamstr...
Eligibility Criteria
Inclusion
- • Primary acute proximal ACL rupture (MRI and per-operative confirmation): 3-digit ACL rupture classification, type A (supplement 1)
- Between 18-50 years, male or female
- Randomization and surgery within 4 weeks after the ACL rupture (Study 1)
- Randomization and surgery between 5-12 weeks after the ACL rupture (Study 2)
- The ACL remnant is suitable for repair in the three treatment groups: the distal ACL remnant must be in contact with the proximal remnant/femoral condyle for at least 75% (per-operative confirmation)
- The patient is mentally and verbally capable of participating in the study.
- Written informed consent (according to the International Conference on Harmonisation (ICH)-GCP Guidelines).
Exclusion
- • Known posterior cruciate ligament (PCL) and/or posterolateral ligamentous complex (PLC), lateral collateral ligament (LCL) or medial collateral ligament (MCL) grade 3 injury.
- Known osseous fractures that could impair revalidation and/or ACL repair
- Patients with neurological disorders or systemic diseases
- Patients with trauma/fractures in the lower limb in the past 6 months that could influence rehabilitation
- Non-sportive patients with a Tegner score of \<3: these patients could probably counteract instability complaints with intensive physiotherapy.
- Any inflammatory disease, Rheumatoid Arthritis (RA), Spondyloarthropathy (SpA), active malignancy
- Patient not suited for intervention due to lack of mobility, meaning not achieving 90° of flexion before surgery.
Key Trial Info
Start Date :
February 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2025
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT03441295
Start Date
February 15 2018
End Date
August 30 2025
Last Update
May 16 2024
Active Locations (3)
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1
University Hospital, Antwerp
Edegem, Antwerp, Belgium, 2650
2
University Hospital, Brussels
Jette, Brussels Capital, Belgium, 1090
3
OLV Hospital
Aalst, Oost-Vlaanderen, Belgium, 9300