An observational study in Lateral Ankle Instability, sponsored by Stryker Trauma and Extremities. Completed at 4 sites in United States. Open to participants aged 14 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Stryker Trauma and Extremities · Observational
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.
Stryker Trauma and Extremities is the lead sponsor of 43 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Approximately 75 subjects underwent an ATFL repair with Arthrex InternalBrace
Exclusion Criteria:
Arthrex InternalBrace is composed of a polyethylene/polyester suture tape and knotless bone anchors to provide ligament repair bridging and reinforce ligament strength. There have been conflicting results surrounding the clinical efficacy of its use in lateral ligament reconstruction.
Evaluate Effectiveness
The overall objective of this study is to evaluate the effectiveness and safety of suture tape when used as an augmentation device during surgical reconstruction of ATFL in patients suffering lateral ankle instability. The assessment of effectiveness will be measured by the rate of complications as defined by those patients that necessitated a return to the OR, including implant failure, symptomatic implant requiring removal, peri-implant fracture, deep wound infection and foreign body reaction.
Time frame: 12 weeks to last recorded follow-up
Evaluate Safety
The overall objective of this study is to evaluate the effectiveness and safety of suture tape when used as an augmentation device during surgical reconstruction of ATFL in patients suffering lateral ankle instability. Safety of study subjects will be established by recording treatment, incidence and frequency of adverse events. Also, adverse events will be classified as procedure related and/or product related.
Time frame: 2 weeks to last recorded follow-up
Plan to share: No — Unknown at this time
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Stryker Trauma and Extremities