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Search / Trial NCT06638138

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

Launched by STRYKER TRAUMA AND EXTREMITIES · Oct 9, 2024

Trial Information

Current as of July 09, 2025

Enrolling by invitation

Keywords

Atfl Reconstructive Procedure Flexband Modified Bröstrom Reconstruction

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Subjects between and including the age of 18-75 at the time of surgery.
  • 2. Subjects who were diagnosed with lateral ankle instability by physician clinical assessment.
  • 3. Subjects who will undergo a modified Bröstrom procedure for an ATFL repair with or without FLEXBAND augmentation device (does not require an isolated repair).
  • 4. Subjects that are able to understand, complete and sign the Consent Form.
  • Exclusion Criteria:
  • 1. Significant secondary procedures done at the time of repair, including significant osteochondral lesions and/or significant microfracture of the talus or tibia that warrant modifying the typical lateral ligament repair post-op rehab protocol (minor microfractures and OCD lesions that do not warrant major bone debridement, synovectomies, and bone spur/osteophyte removals are allowed).
  • 2. Any concomitant orthopedic procedure that will extend the post-op rehabilitation (e.g., casting/immobilization) beyond the routinely prescribed rehab protocol following an ATFL reconstructive procedure.
  • 3. Subjects undergoing a Calcaneal osteotomy.
  • 4. Subjects requiring major additional tendon surgery (i.e., peroneal tendon repair or tenodesis).
  • 5. Neuropathy.
  • 6. Subjects with diabetes, who, in the opinion of the investigator, are not sufficiently controlled.
  • 7. BMI greater than 40 kg/m2.
  • 8. Subjects with active Worker's Compensation Cases
  • 9. Any subject with a history of infection of the ankle predating the ankle repair.
  • 10. Subjects with a systemic ligament laxity disorder (i.e., Ehlers-Danlos Syndrome).
  • 11. Any orthopedic issue outside of the ankle that the Investigator feels may impede functional endpoint outcome measures.
  • 12. Subjects who have a medical history that would likely make the subject an unreliable research participant.
  • 13. Subjects that are nursing or pregnant at the time of surgery.
  • 14. Subjects with physician assessed untreated alcohol or substance abuse at the time of screening.
  • 15. Subjects who are currently enrolled or participated in another investigational device, drug, or biological trial within 60 days of screening.

About Stryker Trauma And Extremities

Stryker Trauma and Extremities is a leading medical technology company dedicated to advancing innovative solutions for the treatment of trauma and orthopedic conditions. With a strong focus on research and development, Stryker is committed to improving patient outcomes through cutting-edge products and comprehensive clinical trials. The company leverages its expertise in trauma and extremity surgery to deliver safe, effective, and minimally invasive solutions that enhance surgical efficiency and promote rapid recovery. By collaborating with healthcare professionals and leveraging data-driven insights, Stryker Trauma and Extremities aims to set new standards in the field of musculoskeletal care.

Locations

Charleston, South Carolina, United States

Gainesville, Florida, United States

Gainesville, Florida, United States

Charlotte, North Carolina, United States

Worthington, Ohio, United States

Phoenix, Arizona, United States

Jacksonville, Florida, United States

Houston, Texas, United States

Falls Church, Virginia, United States

Patients applied

0 patients applied

Trial Officials

Rebecca Gibson

Study Director

Stryker Trauma & Extremities

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported