L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction

Soft Tissue Regeneration, Inc.

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Acute Ruptures of the Anterior Cruciate Ligament

Treatments: Procedure: Hamstring Autograft; Device: L-C Ligament

Study type: Interventional

Funder types: Industry

Identifiers

NCT02183727

LC1060

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

L-C Ligament

Experimental group

Description:

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.

Treatment:

Device: L-C Ligament

Hamstring Autograft

Active Comparator group

Description:

Hamstring autograft is the active comparator for this study. Autograft tissue is the gold-standard treatment for primary ACL reconstruction.

Treatment:

Procedure: Hamstring Autograft