NCT06638138View on ClinicalTrials.gov

Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle Instability

NAEnrolling by invitationINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

August 22, 2023

Primary Completion Date

June 23, 2027

Study Completion Date

June 23, 2027

Conditions
Lateral Ankle Instability
Interventions
DEVICE

Flexband

Artelon FLEXBAND is a commercially available, polycaprolactone polyurethane urea (PCL/PUUR) multipolymer synthetic knitted mesh that is used for soft tissue reinforcement procedures. The device is biocompatible and degradable and has been used as an augmentation device in over 50,000 Orthopedic tendon and ligament reconstructive procedures. The FLEXBAND kits contain the device and all of the instrumentation needed to insert the device.

Trial Locations (8)

22042

The Center for Advanced Orthopedics, Falls Church

28207

OrthoCarolina Research Institute, Charlotte

29425

Medical University of South Carolina, Charleston

32204

Southeast Orthopedic Specialists, Jacksonville

32607

University of Florida, Gainesville

43085

Orthopedic Foot and Ankle Center, Worthington

77030

UT Health Houson, Houston

85023

MORE Foundation, Phoenix

All Listed Sponsors
lead

Stryker Trauma and Extremities

INDUSTRY

NCT06638138 - Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle Instability | Biotech Hunter | Biotech Hunter