NCT02183727TerminatedPhase 2
L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction: A Prospective, Randomized Controlled Trial
Soft Tissue Regeneration, Inc.1 site in 1 country60 target enrollmentStarted: September 1, 2015Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Physical Knee Function measured by the IKDC
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
L-C Ligament
Experimental
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.
Intervention: L-C Ligament (Device)
Hamstring Autograft
Active Comparator
Hamstring autograft is the active comparator for this study. Autograft tissue is the gold-standard treatment for primary ACL reconstruction.
Intervention: Hamstring Autograft (Procedure)
Outcomes
Primary Outcomes
Physical Knee Function measured by the IKDC
Time Frame: 12 Months
Physical Knee Function at 12 Months post procedure
Graft Failure
Time Frame: 12 Months
Revision surgery rate at one year
Secondary Outcomes
- Pain Score(Day 1)
- Adverse event rates(12 months)
Investigators
Study Sites (1)
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