L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction

NCT02183727 | Terminated Phase 2 DMC

• 1 other identifier: LC1060
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Ruptures of the Anterior Cruciate Ligament

Keywords

ACL; knee injury; anterior cruciate ligament

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Pain Score

  Day 1

• Adverse event rates

  12 months

Other Outcomes (3)

• Physical Knee Function as measured by the Lysholm scale

  over 24 months

• Return to Pre-Injury Physical Activity Levels as measured by the Tegner scale

  over 24 months

• Knee Outcomes (Pain, symptoms, ability ot perform daily activities, sports, and quality of life) as measured by the KOOS

  over 24 months

Study Arms (2)

L-C Ligament

EXPERIMENTAL

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

Hamstring Autograft

ACTIVE COMPARATOR

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

Procedure: Hamstring Autograft

Interventions

L-C Ligament DEVICE

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.

L-C Ligament

Hamstring Autograft PROCEDURE

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.

Hamstring Autograft

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with acute ruptures of the ACL who are willing to undergo treatment within 18 weeks of injury

You may not qualify if:

• 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)

Sponsors & Collaborators

• Soft Tissue Regeneration, Inc.: lead

Study Sites (1)

Isala Klinieken

Zwolle, Netherlands

Location

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Kees van Egmond, MD

  Isala Klinieken, Zwolle, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2014
• First Posted: July 8, 2014
• Study Start: September 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: November 22, 2021

Record last verified: 2021-11

Locations

NL (1)