Clinical Evaluation of a Resorbable PLLA Implant for Regeneration of the Anterior Cruciate Ligament (ACL)
Condition: Complete Tear, Knee, Anterior Cruciate Ligament
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety of a resorbable polymer implant (Soft
      Tissue Regeneration's L-C Ligament) for replacement and regeneration of the anterior cruciate
      ligament (ACL). Approximately 15 patients at 2-3 different hospitals in Europe will
      participate in this study. The hypothesis of this study is that the L-C Ligament will
      successfully regenerate the ACL with clinical outcomes similar to or better than surgical
      intervention with auto graft tissue.
    

Detailed description: 
      Reconstruction of the ACL is currently recommended as the standard of care following an ACL
      tear or rupture. The ACL has poor healing potential and repair of the damaged tissue is
      rarely successful. The gold standard for reconstruction of the ACL is autograft tissue, with
      the patellar and hamstring tendons the most common. The limitations of autograft are donor
      site morbidity and pain, and potential damage of the remaining tissue at the harvest site.
      Other problems include a limited amount of tendon available for harvesting, unpredictable
      resorption characteristics, and increased recovery time. Allografts are tissues such as
      patellar, hamstring, and Achilles tendons obtained from cadavers. The advantages of surgery
      with allograft are less pain and scarring, decreased surgical time, and faster
      rehabilitation. However, allografts can transmit disease, may elicit an unfavorable
      immunogenic response, and incorporate slower than autograft. Also, allografts cannot be
      sterilized without damaging the tissue, leading to a choice between a risk of bacterial
      infection and decreased tensile strength and healing potential.

      The proposed study is a prospective, consecutive, non-randomized, multicentre clinical trial
      conducted at up to five European sites, wherein 15 study subjects will undergo primary ACL
      reconstruction with the L-C Ligament. After screening procedures are completed, eligible
      study subjects who provide written informed consent will be enrolled in the study. Subjects
      will undergo preoperative clinical, MRI, and radiographic evaluations and undergo primary ACL
      reconstruction. Follow-up clinical evaluations will be performed post-op (range 1-8 weeks), 3
      months (± 3 weeks), 6 months (± 3 weeks), 12 months (± 1 month), and 24 months (± 2 months)
      after surgery. Assessment of safety (i.e., assessment of adverse events and complications),
      pain, and clinical function as well as imaging will occur.

      In accordance with a separate radiographic protocol, analysis and scoring of MRI images
      (pre-op, 1 and 2 years), radiographs (pre- and post- op), and a CT scan post-op and at 1-year
      will be undertaken by an independent radiologist who will be masked to the identities of the
      subjects and clinical investigators. Outcome measures for imaging include position of the
      bone tunnels and interference screws, indirect evidence of ligament tissue remodeling, and
      evidence of tunnel-widening. Evidence of OA will also be monitored. The Principal
      Investigator and Co-Investigators will ensure that complications observed on radiographs,
      MRI, and CT images are reported to their ethics committee and the sponsor.

      The primary objective of this study is to evaluate the safety of the L-C Ligament in primary
      ACL reconstruction. Safety will be evaluated by the occurrence, frequency, and severity of
      intra- and post- operative complications; the primary end point is one year and follow-up wil
      be performed for a minimum of two years. Clinical function will be assessed with the
      IKDC-2000 Scale and functionality of the device at two years follow-up.

      The secondary objectives of this study are to determine efficacy by objectively and
      subjectively measuring pain, function, and the results of image analyses of the L-C Ligament
      in primary ACL reconstruction. Objective measures include the Lachman test, the anterior
      drawer test, the KT-1000 Arthrometer, the pivot-shift test, and the single-leg hop test. Pre-
      and post- operative objective and subjective measures include the Tegner and Lysholm scales.
      Pre- and post- op radiographs, MRI images pre-op, and at 1 and 2 years, and post-op and
      1-year CT scans will be analyzed for position of the bone tunnels and screws, indirect
      evidence of ligament tissue remodeling, and evidence of widening of the bone tunnels.
    

Intervention name(s): L-C Ligament
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): L-C Ligament. PLLA Scaffold. 3-D Bradied PLLA Devcie.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ACL; Anterior Cruciate Ligament; Ligament; Resorbable polymer; Knee ligament