L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction
This trial is active, not recruiting.
|Condition||acute ruptures of the anterior cruciate ligament|
|Treatments||l-c ligament, hamstring autograft|
|Phase||phase 2/phase 3|
|Sponsor||Soft Tissue Regeneration, Inc.|
|Start date||September 2015|
|End date||September 2016|
|Trial size||60 participants|
|Trial identifier||NCT02183727, LC1060|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
time frame: 12 Months
Physical Knee Function measured by the IKDC
time frame: 12 Months
time frame: Day 1
Adverse event rates
time frame: 12 months
Male or female participants from 18 years up to 45 years old.
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
|Official title||L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction: A Prospective, Randomized Controlled Trial|
|Principal investigator||Kees van Egmond, MD|
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