L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction

Acute Ruptures of the Anterior Cruciate Ligament Clinical Trial

Official title:

L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction: A Prospective, Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02183727
• Other study ID #: LC1060
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: September 2015
• Est. completion date: July 2020

Study information

• Verified date: November 2021
• Source: Soft Tissue Regeneration, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: July 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Ruptures of the Anterior Cruciate Ligament
• Rupture

Intervention

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.

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.

Locations

Country	Name	City	State
Netherlands	Isala Klinieken	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
Soft Tissue Regeneration, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical Knee Function as measured by the Lysholm scale	Physical Knee Function scores at all follow-up timepoints through Month 24	over 24 months
Other	Return to Pre-Injury Physical Activity Levels as measured by the Tegner scale	Physical activity level scores at all follow-up timepoints through Month 24	over 24 months
Other	Knee Outcomes (Pain, symptoms, ability ot perform daily activities, sports, and quality of life) as measured by the KOOS	KOOS scores at all follow-up timepoints through Month 24	over 24 months
Primary	Graft Failure	Revision surgery rate at one year	12 Months
Primary	Physical Knee Function measured by the IKDC	Physical Knee Function at 12 Months post procedure	12 Months
Secondary	Pain Score	Pain levels day 1 post-procedure	Day 1
Secondary	Adverse event rates	Rate of AEs throughout the first year of follow-up	12 months