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L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction

Primary Purpose

Acute Ruptures of the Anterior Cruciate Ligament

Status
Terminated
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
L-C Ligament
Hamstring Autograft
Sponsored by
Soft Tissue Regeneration, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ruptures of the Anterior Cruciate Ligament focused on measuring ACL, knee injury, anterior cruciate ligament

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Isala Klinieken

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

L-C Ligament

Hamstring Autograft

Arm 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.

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

Outcomes

Primary Outcome Measures

Graft Failure
Revision surgery rate at one year
Physical Knee Function measured by the IKDC
Physical Knee Function at 12 Months post procedure

Secondary Outcome Measures

Pain Score
Pain levels day 1 post-procedure
Adverse event rates
Rate of AEs throughout the first year of follow-up

Full Information

First Posted
June 26, 2014
Last Updated
November 12, 2021
Sponsor
Soft Tissue Regeneration, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02183727
Brief Title
L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction
Official Title
L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction: A Prospective, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
Data from LC1033 study of same product indicated lower than expected clinical outcomes; company, STR did not have funds to continue study.
Study Start Date
September 2015 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soft Tissue Regeneration, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ruptures of the Anterior Cruciate Ligament
Keywords
ACL, knee injury, anterior cruciate ligament

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
L-C Ligament
Arm Type
Experimental
Arm 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.
Arm Title
Hamstring Autograft
Arm Type
Active Comparator
Arm Description
Hamstring autograft is the active comparator for this study. Autograft tissue is the gold-standard treatment for primary ACL reconstruction.
Intervention Type
Device
Intervention Name(s)
L-C Ligament
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Hamstring Autograft
Intervention Description
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.
Primary Outcome Measure Information:
Title
Graft Failure
Description
Revision surgery rate at one year
Time Frame
12 Months
Title
Physical Knee Function measured by the IKDC
Description
Physical Knee Function at 12 Months post procedure
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Pain Score
Description
Pain levels day 1 post-procedure
Time Frame
Day 1
Title
Adverse event rates
Description
Rate of AEs throughout the first year of follow-up
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Physical Knee Function as measured by the Lysholm scale
Description
Physical Knee Function scores at all follow-up timepoints through Month 24
Time Frame
over 24 months
Title
Return to Pre-Injury Physical Activity Levels as measured by the Tegner scale
Description
Physical activity level scores at all follow-up timepoints through Month 24
Time Frame
over 24 months
Title
Knee Outcomes (Pain, symptoms, ability ot perform daily activities, sports, and quality of life) as measured by the KOOS
Description
KOOS scores at all follow-up timepoints through Month 24
Time Frame
over 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kees van Egmond, MD
Organizational Affiliation
Isala Klinieken, Zwolle, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Isala Klinieken
City
Zwolle
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction

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