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The goal of this study is to demonstrate the safety and performance of the Incompass™ Total Ankle System after surgery over the standard follow-up period. The study will measure improvements in patient-reported information related to quality of life and pain following surgery. In order to do this, medical imaging (i.e. X-Rays, CT scans) which have been taken as part of routine care, will be reviewed. Any additional X-Rays conducted during the period of the research will also be reviewed.
The Incompass™ Total Ankle System has been cleared by the Food and Drug Administration (FDA). The products are already in use routinely in ankle replacement surgeries. No part of this study is experimental.
It is anticipated that a total of 200 subjects will be enrolled at up to ten sites over a three year enrollment period. The study has been designed to follow the surgeon's standard of care for subjects treated with a total ankle replacement including imaging (x-rays and or CT scans).
The primary endpoint of this study is the 24-month total Ankle Osteoarthritis Scale (AOS) score improvement after index surgery (or Initial Assessment). Secondary endpoints include safety (adverse events, reoperation, and survivorship) as well as performance measures (radiographic assessments, PROMIS Global Health questionnaire, Foot and Ankle Ability Measure [FAAM] and Total Ankle Replacement [TAR] Satisfaction questionnaires).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Incompass™ Total Ankle System | Primary Total Ankle Replacement using the Incompass™ Total Ankle System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Ankle Replacement | Device | Incompass™ Total Ankle System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ankle Osteoarthritis Scale (AOS) | The AOS questionnaire consists of two 9-item subscales: one for pain and one for disability. Each subscale uses a visual analogue scale where patients mark a point on a 100mm horizontal line anchored by "No pain" and "Worst pain imaginable" for pain, or "No difficulty" and "So difficult unable" for disability | Baseline, 6 month, 1 Year, 2 Year, 5 Year, 7 Year, 10 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Foot and Ankle Ability Measure (FAAM) | The FAAM has 29 questions and two components that are scored independently: an Activities of Daily Living (ADL) subscale and a Sports subscale. Each subscale is scored from 0 to 100 points, with higher scores representing better function. | Baseline, 6 month, 1 Year, 2 Year, 5 Year, 7 Year, 10 Year |
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Inclusion Criteria:
Exclusion Criteria:
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No specific methods (such as randomization, blinding or stratification) for assigning participants are used in this protocol. Consecutive participants at each site meeting all of the eligibility criteria will be considered for enrollment in this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caryn Thompson | Contact | 704-891-6540 | caryn.thompson@stryker.com | |
| Rebecca Gibson | Contact | rebecca.gibson@stryker.com |
| Name | Affiliation | Role |
|---|---|---|
| Rebecca Gibson | Stryker Trauma & Extremities | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Illinois Bone and Joint Institute | Recruiting | Morton Grove | Illinois | 60053 | United States |
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| PROMIS Scale v1.2- Global Physical Health Score |
The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score." The average "TScore" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient. |
| Baseline, 6 Month, 1 Year, 2 year, 5 Year, 7 year, 10 Year |
| PROMIS Scale v1.2- Global Mental Health Score | The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score." The average "TScore" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient. | Baseline, 6 Month, 1 Year, 2 year, 5 Year, 7 year, 10 Year |
| TAR Satisfaction | Patient satisfaction with the Incompass™ Total Ankle System post-operatively is assessed utilizing a four-point scale: excellent, good, fair and poor. | 6 month, 1 Year, 2 Year, 5 Year, 7 Year, 10 Year |
| Radiographic Findings | Radiographic assessment for component loosening and/or subsidence, any osteolysis and/or cyst formation early and through the lifetime of the implant. | Baseline, 6 months, 1 year, 2 year, 5 year, 7 year, 10 year. |
| Safety - Adverse Event | The incidence of device-related Adverse Events by 10 years, as collected and reported by the Investigator | Baseline to 10 years postoperative |
| Safety - Survivorship | The survivorship rate by 10 years, as defined with a Kaplan-Meier survivorship analysis. | Baseline to 10 years. |
| Baptist Health Louisville | Recruiting | Louisville | Kentucky | 40207 | United States |
|
| Slocum Research & Education Foundation | Recruiting | Eugene | Oregon | 97401 | United States |
|
| MUSC | Recruiting | Charleston | South Carolina | 29425 | United States |
|
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D058737 | Arthroplasty, Replacement, Ankle |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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