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

NCT03441295 | Active Not Recruiting

• 2 other identifiers: B300201835253T001017N
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 3

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 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

Keywords

ACL

Outcome Measures

Primary Outcomes (1)

• International Knee Documentation Committee (IKDC) Score

  The International Knee Documentation Committee (IKDC) is a commonly used instrument to determine the outcome following various knee procedures, including ACL reconstructions. In essence, it is a subjective well-known tool that provides patients with an overall function score (range between 0 to 100). The score is interpreted as a measure of function with higher scores representing higher levels of function. The questionnaire addresses 3 categories: symptoms (i.e. pain, swelling, stiffness etc.), activity (rising from chair, going up and down stairs, jumping, squatting etc.) and knee function. The knee function studies focus primarily on one question: "How is the knee function post-operative compared to the situation before the injury?". In conclusion, the IKDC score is a reliable, well established and both patient and clinician friendly tool (i.e. it is easy and it requires little time to complete).

  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.

Secondary Outcomes (9)

• Failure (re-rupture/instability complaints)

  Day 1, week 2, week 6, week 13, week 26, week 52, week 104.

• Tegner score

  Baseline (pre-rupture), week 13, week 26, week 52, week 104.

• Lysholm score

  Baseline (pre-rupture), week 13 post-operative, week 26 post-operative, week 52 post-operative, week 104 post-operative

• EQ-5D-5L

  Baseline (pre-operative), day 1, week 2, week 6, week 13, week 26, week 52, week 104.

• Return to work/sport

  Day 1, week 2, week 6, week 13, week 26, week 52, week 104.

Study Arms (4)

Study 1 Ligamys

EXPERIMENTAL

Repair Surgery.

Procedure: Dynamic Intraligamentary Stabilization

Study 1 Internal Bracing

EXPERIMENTAL

Repair Surgery.

Procedure: Internal Brace Ligament Augmentation

Study 2 Internal Bracing

EXPERIMENTAL

Repair Surgery.

Procedure: Internal Brace Ligament Augmentation

Study 2 Reconstruction

ACTIVE COMPARATOR

Reconstructive Surgery.

Procedure: ACL Reconstruction

Interventions

Dynamic Intraligamentary Stabilization PROCEDURE

DIS, Ligamys

Study 1 Ligamys

Internal Brace Ligament Augmentation PROCEDURE

IBLA

Study 1 Internal Bracing; Study 2 Internal Bracing

ACL Reconstruction PROCEDURE

Conventional

Study 2 Reconstruction

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Universitair Ziekenhuis Brussel: collaborator
• Onze Lieve Vrouw Hospital: collaborator

Study Sites (3)

University Hospital, Antwerp

Edegem, Antwerp, 2650, Belgium

Location

University Hospital, Brussels

Jette, Brussels Capital, 1090, Belgium

Location

OLV Hospital

Aalst, Oost-Vlaanderen, 9300, Belgium

Location

Related Publications (1)

• Heusdens CHW, Zazulia K, Roelant E, Dossche L, van Tiggelen D, Roeykens J, Smits E, Vanlauwe J, Van Dyck P. Study protocol: a single-blind, multi-center, randomized controlled trial comparing dynamic intraligamentary stabilization, internal brace ligament augmentation and reconstruction in individuals with an acute anterior cruciate ligament rupture: LIBRƎ study. BMC Musculoskelet Disord. 2019 Nov 18;20(1):547. doi: 10.1186/s12891-019-2926-0.

  PMID: 31739784 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Christiaan Heusdens

  UH, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Also the treating physiotherapist is blinded to the treatment the participant received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Study 1 comparing Ligamys (DIS) and Internal Bracing (N=48). Study 2 comparing Internal Bracing and ACL Reconstruction (N=48).

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: February 22, 2018
• Study Start: February 15, 2018
• Primary Completion: January 15, 2024
• Study Completion: August 30, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

BE (3)