L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction

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

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.

Study Overview

• Status: Terminated
• Conditions: Acute Ruptures of the Anterior Cruciate Ligament
• Intervention / Treatment: Device: L-C Ligament; Procedure: Hamstring Autograft

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Zwolle, Netherlands
    • Isala Klinieken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: L-C Ligament; 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; 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.
Active Comparator: Hamstring Autograft; Hamstring autograft is the active comparator for this study. Autograft tissue is the gold-standard treatment for primary ACL reconstruction.	Procedure: Hamstring Autograft; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Knee Function as measured by the Lysholm scale	Physical Knee Function scores at all follow-up timepoints through Month 24	over 24 months
Return to Pre-Injury Physical Activity Levels as measured by the Tegner scale	Physical activity level scores at all follow-up timepoints through Month 24	over 24 months
Knee Outcomes (Pain, symptoms, ability ot perform daily activities, sports, and quality of life) as measured by the KOOS	KOOS scores at all follow-up timepoints through Month 24	over 24 months

Collaborators and Investigators

• Sponsor: Soft Tissue Regeneration, Inc.
• Investigators: Principal Investigator: Kees van Egmond, MD, Isala Klinieken, Zwolle, The Netherlands

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: June 26, 2014
• First Submitted That Met QC Criteria: July 2, 2014
• First Posted (Estimate): July 8, 2014

Study Record Updates

• Last Update Posted (Actual): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 12, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: ACL; anterior cruciate ligament; knee injury
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: LC1060