L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction

Study Overview
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Brief Summary
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The purpose of this study is to compare safety and efficacy outcomes of the L-C Ligament versus Hamstring Autograft for treatment of acute rupture of the ACL.

Official Title
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L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction: A Prospective, Randomized Controlled Trial

Conditions
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Acute Ruptures of the Anterior Cruciate Ligament

Intervention / Treatment
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* Device: L-C Ligament
* Procedure: Hamstring Autograft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with acute ruptures of the ACL who are willing to undergo treatment within 18 weeks of injury Exclusion Criteria: Prior ACL reconstruction or other surgical procedure on the affected (target) knee Chronic ACL injury; interventional surgery scheduled 127 days or more after ACL injury Professional athletes currently engaged in active sport Prior distal femoral and/or proximal tibial fracture(s) of the target leg Previous or current ACL injury on contra-lateral leg Multi-ligament reconstruction Malalignment or varus thrust Patient > 193 cm tall (6' 4) The patient does not follow pre-operative rehabilitation that may have been prescribed post-injury (prior to Index Procedure) Confirmed connective tissue disorder Signs of moderate to severe degenerative joint disease Severe pain, swelling, or redness within 24 hours prior to surgery Complete or partial Posterior Cruciate Ligament (PCL) tear If concomitant meniscal injury is present, any of the following: 1/3rd meniscal resection; complex double-bucket tear; partially repaired meniscal tears Any type of lateral and/or medial meniscal tear which is not repairable (<2mm from rim) Additional concomitant injuries to the knee or lower extremities requiring treatment, per surgeon's discretion, that are not allowable under the Inclusion criteria The patient is unwilling to not participate in sporting activities for at least 9 months post-procedure The patient is mentally compromised The patient has a neuromuscular disorder that would engender unacceptable risk of knee instability, prosthesis fixation failure, or complications in postoperative care The patient has an active or latent infection in or about the affected knee joint or an infection site distant from the knee that may spread to the knee hematogenously Pregnant based on a positive beta hCG serum or an in vitro diagnostic test result or breast-feeding The patient is obese with a BMI > 35 The patient has a known allergy to PLLA The patient has a medical condition or comorbidity that would interfere with study participation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-C Ligament<br>Soft Tissue Regeneration's L-C Ligament is an investigation, interventional device intended for ACL reconstruction surgery within 18 weeks of acute rupture of the ACL and no previous surgical treatment. The L-C Ligament temporarily replaces the human anterior cruciate ligament (ACL) and provides a bioresorbable scaffold within and around which the native ACL will regenerate over time. | Device: L-C Ligament<br>* The L-C Ligament is a bioresorbable, three-dimensional (3-D) braided scaffold made from poly L-lactic acid (PLLA) fiber. One device is used to replace the ACL. The L-C Ligament is an interventional device. The L-C Ligament is comprised of three regions: (1) The femoral tunnel attachment site, (2) The ligament region (intra-articular zone), and (3) The tibial tunnel attachment site. For several months after surgery, the L-C Ligament replaces the function of the ACL. During this time, ligament tissue regenerates within and around the L-C Ligament, which is slowly absorbed and replaced by the ACL.<br>|
| Active Comparator: Hamstring Autograft<br>Hamstring autograft is the active comparator for this study. Autograft tissue is the gold-standard treatment for primary ACL reconstruction. | Procedure: Hamstring Autograft<br>* The gold-standard treatment for ACL reconstruction is autograft tissue. Autograft is a piece of tendon harvested from another part of the patient's body, such as the hamstring or kneecap. In this study, the hamstring tendon from the back of the thigh of the injured (target) leg will be harvested and surgically transferred to replace the torn ACL. The attachment of the autologous tendon in the femoral and tibial bone tunnels will utilize techniques that are similar to those for the L-C Ligament. Over time the replacement tendon resorbs and a new ACL is regenerated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft Failure | Revision surgery rate at one year | 12 Months | 
| Physical Knee Function measured by the IKDC | Physical Knee Function at 12 Months post procedure | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | Pain levels day 1 post-procedure | Day 1 | 
| Adverse event rates | Rate of AEs throughout the first year of follow-up | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL, knee injury, anterior cruciate ligament