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

Not Applicable

• Conditions: Lateral Ankle Instability

• Registration Number: NCT06638138
• Lead Sponsor: Stryker Trauma and Extremities

Brief Summary

The goal of this clinical trial is to analzye return to pre-injury activity level on study participants with lateral ankle instability undergoing a modified Bröstrom reconstruction procedure for repair of the ATFL. Study participants undergoing ATFL reconstructive procedure using the ARTELON FLEXBAND System as an augmentation device will be compared to study participants undergoing a standard modified Bröstrom procedure alone. Clinician reported safety and functional outcomes measures will be collected at baseline; and at 2-, 6-, 12-, 18 and 26-weeks and 1- and 2-years post-surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-22
• Study First Submitted: 2024-09-05
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-09
• Last Update Submitted: 2024-10-09
• Study First Posted: 2024-10-11
• Last Update Posted: 2024-10-11
• Primary Completion: 2027-06-23
• Study Completion: 2027-06-23

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 92

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint	From 2 weeks post-surgery to 26 weeks post-surgery.	The primary outcome measure will be subject reported assessment of time to pre-injury activity level.
Primary Safety Endpoint	Time of surgery to 2 years post-surgery	The primary safety endpoints listed below will be recorded as adverse events and qualified as to whether they are procedure or product related.; • Adverse Events related to the procedure including: * Delayed wound healing (4wks post-surgery); * Wound infection (superficial or deep); * Neuritis (persistent 6wks post-surgery); * Peri-implant osteolysis; * Reoperations of the index ankle; * Revisions of the ligament repair Additionally, complications necessitating a return to OR due to implant failure, foreign body reaction, or deep wound infection will be captured and characterized.

Secondary Outcome Measures

Name	Time	Method
Physician Assessment of Healing	From 2 weeks post-surgery to 26 weeks post-surgery	Subjects will complete post-surgery study follow-up visits during which time the physician assessment of healing will be completed.
Anterior Drawer Assessment	From 2 weeks post-surgery to 26 weeks post-surgery	Subjects will complete post-surgery study follow-up visits during which time the anterior drawer assessment will be completed.
Talar Tilt Assessment	From 2 weeks post-surgery to 26 weeks post-surgery	Subjects will complete post-surgery study follow-up visits during which time the talar tilt assessment will be completed.
Pain Medication Usage	From 2 weeks post-surgery to 26 weeks post-surgery	Subjects will complete post-surgery study follow-up visits during which time the physician will document pain medication usage.
FAAM	From 2 weeks post-surgery to 26 weeks post-surgery	The Foot and Ankle Ability Measure (FAAM) score is a percentage that indicates a patient's level of foot and ankle function. The FAAM is a survey that uses a 5-point Likert scale to score each item. The scale ranges from 4 for "no difficulty" to 0 for "unable to do". Patients can also select "not applicable" if the item doesn't apply to them.
FFI	From 2 weeks post-surgery to 26 weeks post-surgery	The Foot Function Index (FFI) is a self-administered questionnaire that measures the impact of foot problems on a person's pain, disability, and activity restriction. The FFI uses a visual analog scale (VAS) to rate each item on a scale of 0 to 100, with higher scores indicating more pain, disability, or limitation.
CAIT	From 2 weeks post-surgery to 26 weeks post-surgery	The Cumberland Ankle Instability Tool (CAIT) score is a number that indicates the severity of ankle instability. The CAIT score ranges from 0 to 30, with 30 being the best possible score and 0 being the worst.
VAS Pain	From 2 weeks post-surgery to 26 weeks post-surgery	A VAS score is a measurement of pain intensity or other sensations and feelings using a visual analog scale. The VAS is scored by the following measures: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
EQ-5D-5L	From 2 weeks post-surgery to 26 weeks post-surgery	Consists of a 5-question measure where patients rate their health today on a 5-point scale on a 5-dimension scale and a visual analogue scale to measure overall health status.
Patient Satisfaction Scores	From 2 weeks post-surgery to 26 weeks post-surgery	A subjective questionnaire measuring patient satisfaction will be collected follow-up visits.
FOTO	From 2 weeks post-surgery to 26 weeks post-surgery	A subset of study sites will additionally collect FOTO data. The Focus on Therapeutic Outcomes (FOTO) is a numerical value that measures a patient's functional ability. Scores range from 0 (low function) to 100 (high function).

Trial Locations

Locations (8)

MORE Foundation; 🇺🇸 Phoenix, Arizona, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Southeast Orthopedic Specialists; 🇺🇸 Jacksonville, Florida, United States

OrthoCarolina Research Institute; 🇺🇸 Charlotte, North Carolina, United States

Orthopedic Foot and Ankle Center; 🇺🇸 Worthington, Ohio, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

UT Health Houson; 🇺🇸 Houston, Texas, United States

The Center for Advanced Orthopedics; 🇺🇸 Falls Church, Virginia, United States