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L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction

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ClinicalTrials.gov Identifier: NCT02183727
Recruitment Status : Terminated (new product design)
First Posted : July 8, 2014
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Soft Tissue Regeneration, Inc.

Tracking Information
First Submitted Date  ICMJE June 26, 2014
First Posted Date  ICMJE July 8, 2014
Last Update Posted Date April 26, 2017
Study Start Date  ICMJE September 2015
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2014)
  • Graft Failure [ Time Frame: 12 Months ]
    Revision surgery rate at one year
  • Physical Knee Function measured by the IKDC [ Time Frame: 12 Months ]
    Physical Knee Function at 12 Months post procedure
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2014)
  • Pain Score [ Time Frame: Day 1 ]
    Pain levels day 1 post-procedure
  • Adverse event rates [ Time Frame: 12 months ]
    Rate of AEs throughout the first year of follow-up
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 2, 2014)
  • Physical Knee Function as measured by the Lysholm scale [ Time Frame: over 24 months ]
    Physical Knee Function scores at all follow-up timepoints through Month 24
  • Return to Pre-Injury Physical Activity Levels as measured by the Tegner scale [ Time Frame: over 24 months ]
    Physical activity level scores at all follow-up timepoints through Month 24
  • Knee Outcomes (Pain, symptoms, ability ot perform daily activities, sports, and quality of life) as measured by the KOOS [ Time Frame: over 24 months ]
    KOOS scores at all follow-up timepoints through Month 24
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction
Official Title  ICMJE L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction: A Prospective, Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Ruptures of the Anterior Cruciate Ligament
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: L-C Ligament
  • Active Comparator: Hamstring Autograft
    Hamstring autograft is the active comparator for this study. Autograft tissue is the gold-standard treatment for primary ACL reconstruction.
    Intervention: Procedure: Hamstring Autograft
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: July 2, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02183727
Other Study ID Numbers  ICMJE LC1060
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Soft Tissue Regeneration, Inc.
Study Sponsor  ICMJE Soft Tissue Regeneration, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kees van Egmond, MD Isala Klinieken, Zwolle, The Netherlands
PRS Account Soft Tissue Regeneration, Inc.
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP