Clinical Evaluation of a Resorbable PLLA Implant for Regeneration of the Anterior Cruciate Ligament (ACL)
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.
Complete Tear, Knee, Anterior Cruciate Ligament
Device: L-C Ligament
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective and Consecutive Clinical Evaluation of Soft Tissue Regeneration's L-C Ligament® in Primary ACL Reconstruction|
- The anterior cruciate ligament (ACL) is clinically functional at one year follow-up [ Time Frame: One year ] [ Designated as safety issue: Yes ]The primary outcome measure is that the ACL is functional one year postoperatively, and that no revision surgery was performed because of failure of the study device or loss of fixation directly attributable to the study device.
- International Knee Documentation Committee (IKDC) score [ Time Frame: Pre-op, 6, 12, and 24 months ] [ Designated as safety issue: No ]
- Tegner Activity score [ Time Frame: Pre-op, 6, 12, & 24 months ] [ Designated as safety issue: No ]
- Lachman test [ Time Frame: Pre-op, 6, 12, and 24 months ] [ Designated as safety issue: No ]
- KT-1000 Arthrometer score [ Time Frame: Pre-op, 6, 12, 24 months ] [ Designated as safety issue: No ]
- Lysholm Knee Score [ Time Frame: pre-op, 6, 12, 24 months ] [ Designated as safety issue: No ]
- Lachman Test score [ Time Frame: pre-op, 6, 12, 24 months ] [ Designated as safety issue: No ]
- Pivot Shift [ Time Frame: pre-op, 6, 12, 24 months ] [ Designated as safety issue: No ]
- Single-Leg Hop test [ Time Frame: pre-op, 6, 12, 24 months ] [ Designated as safety issue: No ]
- Anterior Drawer Test [ Time Frame: pre-op, 6, 12, 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: The L-C Ligament
Soft Tissue Regeneration's L-C Ligament is an interventional device intended for ACL reconstruction surgery within 13 weeks of acute rupture of the ACL and no previous 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
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 Name: L-C Ligament. PLLA Scaffold. 3-D Bradied PLLA Devcie.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01634711
|Groningen, Netherlands, 30033|
|Isala Klinieken - locatie Weezenlanden|