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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLEXBAND | Active Comparator | This group will undergo a lateral ankle ligament repair using the modified Broström technique with Artelon FLEXBAND augmentation of the ATFL. |
|
| Control | No Intervention | This group will undergo a lateral ankle ligament repair using the modified Broström technique. This technique utilizes anchors to repair the ATFL, in some cases the CFL, lateral ankle capsule and extensor retinaculum. This will be done without Artelon FLEXBAND augmentation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flexband | Device | Artelon FLEXBAND is a commercially available, polycaprolactone polyurethane urea (PCL/PUUR) multipolymer synthetic knitted mesh that is used for soft tissue reinforcement procedures. The device is biocompatible and degradable and has been used as an augmentation device in over 50,000 Orthopedic tendon and ligament reconstructive procedures. The FLEXBAND kits contain the device and all of the instrumentation needed to insert the device. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy Endpoint | The primary outcome measure will be subject reported assessment of time to pre-injury activity level. | From 2 weeks post-surgery to 26 weeks post-surgery. |
| Primary Safety Endpoint | 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:
| Time of surgery to 2 years post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Assessment of Healing | Subjects will complete post-surgery study follow-up visits during which time the physician assessment of healing will be completed. | From 2 weeks post-surgery to 26 weeks post-surgery |
| Anterior Drawer Assessment |
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Inclusion Criteria:
Exclusion Criteria:
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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 | ||
| University of Florida |
Unknown at this time.
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Subjects will complete post-surgery study follow-up visits during which time the anterior drawer assessment will be completed.
| From 2 weeks post-surgery to 26 weeks post-surgery |
| Talar Tilt Assessment | Subjects will complete post-surgery study follow-up visits during which time the talar tilt assessment will be completed. | From 2 weeks post-surgery to 26 weeks post-surgery |
| Pain Medication Usage | Subjects will complete post-surgery study follow-up visits during which time the physician will document pain medication usage. | From 2 weeks post-surgery to 26 weeks post-surgery |
| FAAM | 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. | From 2 weeks post-surgery to 26 weeks post-surgery |
| FFI | 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. | From 2 weeks post-surgery to 26 weeks post-surgery |
| CAIT | 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. | From 2 weeks post-surgery to 26 weeks post-surgery |
| VAS Pain | 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) | From 2 weeks post-surgery to 26 weeks post-surgery |
| EQ-5D-5L | 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. | From 2 weeks post-surgery to 26 weeks post-surgery |
| Patient Satisfaction Scores | A subjective questionnaire measuring patient satisfaction will be collected follow-up visits. | From 2 weeks post-surgery to 26 weeks post-surgery |
| FOTO | 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). | From 2 weeks post-surgery to 26 weeks post-surgery |
| Gainesville |
| Florida |
| 32607 |
| United States |
| Southeast Orthopedic Specialists | Jacksonville | Florida | 32204 | United States |
| OrthoCarolina Research Institute | Charlotte | North Carolina | 28207 | United States |
| Orthopedic Foot and Ankle Center | Worthington | Ohio | 43085 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| UT Health Houson | Houston | Texas | 77030 | United States |
| The Center for Advanced Orthopedics | Falls Church | Virginia | 22042 | United States |