Clinical trial NCT06638138: Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle Instability
Official title: A Multi-center, Prospective, Blinded, Randomized Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle Instability
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Lateral Ankle Instability
Keywords: ATFL reconstructive procedure
Flexband
modified Bröstrom reconstruction
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Primary Efficacy Endpoint
timeFrame: From 2 weeks post-surgery to 26 weeks post-surgery.
measure: Primary Safety Endpoint
timeFrame: Time of surgery to 2 years post-surgery
Secondary outcomes:
measure: Physician Assessment of Healing
timeFrame: From 2 weeks post-surgery to 26 weeks post-surgery
measure: Anterior Drawer Assessment
timeFrame: From 2 weeks post-surgery to 26 weeks post-surgery
measure: Talar Tilt Assessment
timeFrame: From 2 weeks post-surgery to 26 weeks post-surgery
measure: Pain Medication Usage
timeFrame: From 2 weeks post-surgery to 26 weeks post-surgery
measure: FAAM
timeFrame: From 2 weeks post-surgery to 26 weeks post-surgery
measure: FFI
timeFrame: From 2 weeks post-surgery to 26 weeks post-surgery
measure: CAIT
timeFrame: From 2 weeks post-surgery to 26 weeks post-surgery
measure: VAS Pain
timeFrame: From 2 weeks post-surgery to 26 weeks post-surgery
measure: EQ-5D-5L
timeFrame: From 2 weeks post-surgery to 26 weeks post-surgery
measure: Patient Satisfaction Scores
timeFrame: From 2 weeks post-surgery to 26 weeks post-surgery
measure: FOTO
timeFrame: From 2 weeks post-surgery to 26 weeks post-surgery
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: MORE Foundation
state: Arizona
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Southeast Orthopedic Specialists
state: Florida
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute
state: North Carolina
city: Worthington
country: United States
facility: Orthopedic Foot and Ankle Center
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: UT Health Houson
state: Texas
city: Falls Church
country: United States
facility: The Center for Advanced Orthopedics
state: Virginia
Study officials:
affiliation: Stryker Trauma & Extremities
name: Rebecca Gibson
role: STUDY_DIRECTOR
References: