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
|Condition or disease||Intervention/treatment||Phase|
|Acute Ruptures of the Anterior Cruciate Ligament||Device: L-C Ligament Procedure: Hamstring Autograft||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction: A Prospective, Randomized Controlled Trial|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||September 2020|
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.
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.
Active Comparator: Hamstring Autograft
Hamstring autograft is the active comparator for this study. Autograft tissue is the gold-standard treatment for primary ACL reconstruction.
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.
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02183727
|Principal Investigator:||Kees van Egmond, MD||Isala Klinieken, Zwolle, The Netherlands|