L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction

Phase 2

Terminated

• Conditions: Acute Ruptures of the Anterior Cruciate Ligament

• Registration Number: NCT02183727
• Lead Sponsor: Soft Tissue Regeneration, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-26
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-08
• Study Start: 2015-09
• Primary Completion: 2020-06
• Study Completion: 2020-07
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-12
• Last Update Posted: 2021-11-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Physical Knee Function measured by the IKDC	12 Months	Physical Knee Function at 12 Months post procedure
Graft Failure	12 Months	Revision surgery rate at one year

Secondary Outcome Measures

Name	Time	Method
Adverse event rates	12 months	Rate of AEs throughout the first year of follow-up
Pain Score	Day 1	Pain levels day 1 post-procedure

Trial Locations

Locations (1)

Isala Klinieken; 🇳🇱 Zwolle, Netherlands