Clinical trial NCT06829667: Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle Instability
Official title: An Open Label, Single Cohort, Multi-center, Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle Instability
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Lateral Ankle Instability
Keywords: ATFL reconstructive procedure
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2025-02-17
Enrollment: 75
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 75 subjects underwent an ATFL repair with Arthrex InternalBrace

Brief summary: This study is intended to be a retrospective chart review of patients with chronic ankle instability who have undergone a lateral ligament reconstructive procedure for ATFL repair (isolated or non-isolated) with suture tape augmentation. Patients that have been treated at any of the participating institutions that have undergone an ATFL reconstruction with Arthrex InternalBrace augmentation who have postoperative hospital or ASC records of safety and effectiveness as measured by adverse events, potential complications, and potential functional outcomes past the 10-week time point will be included.


Eligibility criteria: Inclusion Criteria:

* Patients between and including the age of 14-75 at the time of surgery
* Patients who were diagnosed with lateral ankle instability by physician clinical assessment
* Patients who underwent an ATFL repair with Arthrex InternalBrace augmentation device (does not require an isolated repair)

Exclusion Criteria:

* 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 bone debridements, synovectomies, and bone spur removals are allowed)
* 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.
* Patients undergoing a Calcaneal osteotomy
* Patients with less than 6 weeks follow-up
* Patients with incomplete medical records
* Patients with Worker's Compensation Cases
* Any patient with a history of infection of the ankle predating the ankle repair
* Any orthopedic issue outside of the ankle that the Investigator feels may impede functional endpoint outcome measures.
* Patients who have a medical history that would likely make the patient an unreliable research participant

Primary outcomes:
measure: Evaluate Effectiveness
timeFrame: 12 weeks to last recorded follow-up
measure: Evaluate Safety
timeFrame: 2 weeks to last recorded follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: MORE Foundation
state: Arizona
city: Kansas City
country: United States
facility: KUMC
state: Kansas
city: Ocean City
country: United States
facility: Seaview Orthopaedics
state: New Jersey
city: Chattanooga
country: United States
facility: ERLANGER
state: Tennessee
Study officials:
affiliation: Stryker Trauma & Extremities
name: Rebecca Gibson
role: STUDY_DIRECTOR
References: