Active — Not RecruitingNot Applicable

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

Belgium95 participantsStarted 2018-02-15

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * • 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 Criteria: * • 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 l…

What they're measuring

International Knee Documentation Committee (IKDC) Score

Timeframe: Baseline (pre-rupture), week 13, week 26, week 52, week 104. At 6 months follow-up the primary outcome will be measured, a change of 13 IKDC points between the treatments is considered clinically meaningful.

Trial details

NCT IDNCT03441295

SponsorUniversity Hospital, Antwerp

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-15