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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthrex InternalBrace | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 2 weeks to last recorded follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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Approximately 75 subjects underwent an ATFL repair with Arthrex InternalBrace
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Gibson | Stryker Trauma & Extremities | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MORE Foundation | Phoenix | Arizona | 85023 | United States | ||
| KUMC |
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| Kansas City |
| Kansas |
| 66103 |
| United States |
| Seaview Orthopaedics | Ocean City | New Jersey | 07712 | United States |
| ERLANGER | Chattanooga | Tennessee | 37403 | United States |