A Prospective and Consecutive Clinical Evaluation of Soft Tissue Regeneration's L-C Ligament® in Primary ACL Reconstruction

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.