Clinical Evaluation of a Resorbable PLLA Implant for Regeneration of the Anterior Cruciate Ligament (ACL)

NCT01634711 | Completed Phase 1

• 1 other identifier: LC 1033, Version 3.0
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the safety of a resorbable polymer implant (Soft Tissue Regeneration's L-C Ligament) for replacement and regeneration of the anterior cruciate ligament (ACL). Approximately 15 patients at 2-3 different hospitals in Europe will participate in this study. The hypothesis of this study is that the L-C Ligament will successfully regenerate the ACL with clinical outcomes similar to or better than surgical intervention with auto graft tissue.

Conditions

Complete Tear, Knee, Anterior Cruciate Ligament

Keywords

ACL; Anterior Cruciate Ligament; Ligament; Resorbable polymer; Knee ligament

Outcome Measures

Primary Outcomes (1)

• The anterior cruciate ligament (ACL) is clinically functional at one year follow-up

  The primary outcome measure is that the ACL is functional one year postoperatively, and that no revision surgery was performed because of failure of the study device or loss of fixation directly attributable to the study device.

  One year

Secondary Outcomes (9)

• International Knee Documentation Committee (IKDC) score

  Pre-op, 6, 12, and 24 months

• Tegner Activity score

  Pre-op, 6, 12, & 24 months

• Lachman test

  Pre-op, 6, 12, and 24 months

• KT-1000 Arthrometer score

  Pre-op, 6, 12, 24 months

• Lysholm Knee Score

  pre-op, 6, 12, 24 months

Study Arms (1)

The L-C Ligament

EXPERIMENTAL

Soft Tissue Regeneration's L-C Ligament is an interventional device intended for ACL reconstruction surgery within 13 weeks of acute rupture of the ACL and no previous 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

Interventions

L-C Ligament DEVICE

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.

Also known as: L-C Ligament. PLLA Scaffold. 3-D Bradied PLLA Devcie.

The L-C Ligament

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• to 45 years of age.
• Males and females.
• If female, for the 24 months post-operative, actively practicing a contraception method, or surgically sterilised or postmenopausal.
• Acute unilateral ACL tear, or partial or complete tear of the ACL that occurred within 18 weeks of injury, and requires reconstruction of the ACL.
• Passive flexion ≥ 120° and passive extension on the target knee is the same as the contralateral knee.
• Patients with all types of lateral and/or medial meniscal tears which are repairable.
• Medial Collateral Ligament (MCL) grade 2 or less. Potential Subject is able to provide informed consent and must sign the EC-approved Informed Consent Form.
• Must be physically and mentally willing and able to comply with post-operative rehabilitation and routinely scheduled clinical, radiographic and rehabilitation follow up visits through 24 months.

You may not qualify if:

• Prior ACL reconstruction or other surgical procedure on the affected (target) knee.
• Chronic ACL injury; interventional surgery scheduled 18 weeks or more after ACL injury.
• Professional athletes currently engaged in active sport
• Prior fracture of the affected (target) leg
• Previous or current ACL injury on contra-lateral leg.
• Multi-ligament reconstruction.
• Malalignment with varus thrust
• Patient greater than 193 cm tall (6' 4").
• The patient does not follow pre-operative rehabilitation.
• Confirmed connective tissue disorder.
• Signs of moderate to severe degenerative joint disease (Osteoarthritis)
• Concomitant injuries to the knee or lower extremities requiring treatment, per surgeon's discretion.
• Severe pain, swelling, or redness within 24 hours prior to surgery.
• Complete or partial Post Cruciate Ligament (PCL) tear.
• Any of the following: 1/3rd meniscal resection; complex double-bucket tear; partially repaired meniscal tears.

Sponsors & Collaborators

• Soft Tissue Regeneration, Inc.: lead

Study Sites (2)

Martini ziekenhuis

Groningen, 30033, Netherlands

Location

Isala Klinieken - locatie Weezenlanden

Zwolle, Netherlands

Location

Related Links

• For additional info and business inquries, visit www.softtissueregeneration.com or contact Joe Reilly, CEO, at jwreilly@softtissueregeneration.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2012
• First Posted: July 6, 2012
• Study Start: June 1, 2013
• Primary Completion: March 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 19, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)