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This is a randomized study to prospectively compare and evaluate the functional outcome and patient satisfaction of total ankle replacements for tibio-talar osteoarthritis using either the STAR or Salto-Talaris prothesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salto Talaris Total Ankle Replacement | Other |
| |
| STAR Total Ankle Replacement | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salto-Talaris Total Ankle Replacement | Device | Salto-Talaris Total ankle replacement surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Following a Total Ankle Replacement as Measured by the Visual Analog Scale (VAS) for Pain | To assess changes in pain across time following total ankle replacement. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a mark on a 100mm line that represents a continuum between "no pain" and "worst pain." A score of 0 represents less pain intensity while a score of 100 represents high pain intensity | Baseline, 6 months, 1 year, 2 years, 3 years |
| Functional Health Following a Total Ankle Replacement Using the 36-Item Short Form Health Survey (SF-36). | The SF-36 comprises 36 questions which cover eight domains of health: Limitations in physical activities because of health problems, Limitations in social activities because of physical or emotional problems, Limitations in usual role activities because of physical health problems, Bodily pain, General mental health (psychological distress and well-being), Limitations in usual role activities because of emotional problems, Vitality (energy and fatigue), and General health perceptions. Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high Quality of Life (QOL). Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability | Baseline, 6 months, 1 year, 2 years, 3 years |
| Physical Limitations Following a Total Ankle Replacement as Measured by the Short Musculoskeletal Function Assessment (SMFA) Questionnaire. | The SMFA consists of two sections: 34 questions covering the assessment of the patient's function and 12 questions covering how bothered patients are by their symptoms. Items are scored in six categories: daily activities, emotional status, arm and hand function, mobility category, and bother index. On a scale of 1 to 5, patients rate their ability on each item and higher total scores represent greater degree of dysfunction or bother. SMFA higher total score represent greater degree of dysfunction or bother. The lowest score is 0 representing the best possible function and the highest score is 100 representing an overall higher degree of dysfunction or bother. |
| Measure | Description | Time Frame |
|---|---|---|
| Three Dimensional Kinematic and Kinetic Assessment During Level Walking Across Time Following Total Ankle Replacement. | In order to understand the effect of the ankle replacement on lower extremity kinematics and kinetics, each subject will be asked to complete a series of functional tasks and level walking trials at each of the study timepoints. | Baseline, 6 months, 1 year, 2 years, 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James A Nunley, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Medical Plaza Page Road | Durham | North Carolina | 27703 | United States |
Two subjects were not randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Salto-Talaris Total Ankle Replacement | Salto-Talaris Total Ankle Replacement surgery |
| FG001 | STAR Total Ankle Replacement | STAR Total Ankle Replacement: STAR Total Ankle Replacement |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants with data collected at all timepoints.
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| ID | Title | Description |
|---|---|---|
| BG000 | Salto-Talaris Total Ankle Replacement | Salto-Talaris Total Ankle Replacement surgery |
| BG001 | STAR Total Ankle Replacement | STAR Total Ankle Replacement: STAR Total Ankle Replacement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Following a Total Ankle Replacement as Measured by the Visual Analog Scale (VAS) for Pain | To assess changes in pain across time following total ankle replacement. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a mark on a 100mm line that represents a continuum between "no pain" and "worst pain." A score of 0 represents less pain intensity while a score of 100 represents high pain intensity | Data not collected at 3 years. | Posted | Mean | Standard Deviation | mm | Baseline, 6 months, 1 year, 2 years, 3 years |
|
Up to 7 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Salto-Talaris Total Ankle Replacement | Salto-Talaris Total Ankle Replacement surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment | Unrelated to study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Nunley II, M.D. | Duke University | 919-684-4033 | james.nunley@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 15, 2016 | Feb 19, 2021 | Prot_SAP_000.pdf |
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| STAR Total Ankle Replacement | Device | STAR Total Ankle Replacement |
|
| Baseline, 6 months, 1 year, 2 years, 3 years |
| Pain and Function Following a Total Ankle Replacement as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Rating System | The AOFAS Ankle-Hindfoot Rating System is a standardized evaluation of the clinical status of the ankle-hindfoot. Patients report their pain and physicians assess alignment; the patient and physician work together to complete the functional portion. Scores range from 0 to 100, with healthy ankles receiving 100 points. | Baseline, 6 months, 1 year, 2 years, 3 years |
| To Measure a Change in One's Daily Activity Following a Total Ankle Replacement Using the Foot and Ankle Disability Index (FADI) at Multiple Time Points. | The FADI has 26 items, each of which is scored from 0 (unable to do) to 4 (no difficulty at all). The four pain items of the FADI are scored 0 (none) to 4 (unbearable). The total score ranges 0 to 104 with higher scores indicating a better outcome. | Baseline, 6 months, 1 year, 2 years, 3 years |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Smoking status | Data not collected on 2 participants in the STAR Total Ankle Replacement group. | Count of Participants | Participants |
|
| Diabetes | Data not collected on 2 participants in the STAR Total Ankle Replacement group. | Count of Participants | Participants |
|
STAR Total Ankle Replacement |
|
|
|
| Primary | Functional Health Following a Total Ankle Replacement Using the 36-Item Short Form Health Survey (SF-36). | The SF-36 comprises 36 questions which cover eight domains of health: Limitations in physical activities because of health problems, Limitations in social activities because of physical or emotional problems, Limitations in usual role activities because of physical health problems, Bodily pain, General mental health (psychological distress and well-being), Limitations in usual role activities because of emotional problems, Vitality (energy and fatigue), and General health perceptions. Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high Quality of Life (QOL). Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability | Data not collected at 3 years. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months, 1 year, 2 years, 3 years |
|
|
|
|
| Primary | Physical Limitations Following a Total Ankle Replacement as Measured by the Short Musculoskeletal Function Assessment (SMFA) Questionnaire. | The SMFA consists of two sections: 34 questions covering the assessment of the patient's function and 12 questions covering how bothered patients are by their symptoms. Items are scored in six categories: daily activities, emotional status, arm and hand function, mobility category, and bother index. On a scale of 1 to 5, patients rate their ability on each item and higher total scores represent greater degree of dysfunction or bother. SMFA higher total score represent greater degree of dysfunction or bother. The lowest score is 0 representing the best possible function and the highest score is 100 representing an overall higher degree of dysfunction or bother. | Data not collected at 3 years. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months, 1 year, 2 years, 3 years |
|
|
|
|
| Primary | Pain and Function Following a Total Ankle Replacement as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Rating System | The AOFAS Ankle-Hindfoot Rating System is a standardized evaluation of the clinical status of the ankle-hindfoot. Patients report their pain and physicians assess alignment; the patient and physician work together to complete the functional portion. Scores range from 0 to 100, with healthy ankles receiving 100 points. | Data not collected at 3 years. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months, 1 year, 2 years, 3 years |
|
|
|
|
| Primary | To Measure a Change in One's Daily Activity Following a Total Ankle Replacement Using the Foot and Ankle Disability Index (FADI) at Multiple Time Points. | The FADI has 26 items, each of which is scored from 0 (unable to do) to 4 (no difficulty at all). The four pain items of the FADI are scored 0 (none) to 4 (unbearable). The total score ranges 0 to 104 with higher scores indicating a better outcome. | Data not collected at 3 years. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months, 1 year, 2 years, 3 years |
|
|
|
| Secondary | Three Dimensional Kinematic and Kinetic Assessment During Level Walking Across Time Following Total Ankle Replacement. | In order to understand the effect of the ankle replacement on lower extremity kinematics and kinetics, each subject will be asked to complete a series of functional tasks and level walking trials at each of the study timepoints. | Data not collected. | Posted | Baseline, 6 months, 1 year, 2 years, 3 years |
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | STAR Total Ankle Replacement | STAR Total Ankle Replacement: STAR Total Ankle Replacement | 1 | 50 | 1 | 50 | 0 | 50 |
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| Never |
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| 6 months |
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| 1 year |
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| 2 years |
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| 3 years |
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| 6 months |
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| 1 year |
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| 6 months |
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| 1 year |
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| 2 years |
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| 3 years |
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| 6 months |
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| 1 year |
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| 2 years |
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| 3 years |
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