Ankle Osteoarthritis
Conditions
Brief summary
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.
Interventions
DEVICESalto-Talaris Total Ankle Replacement
Salto-Talaris Total ankle replacement surgery
DEVICESTAR Total Ankle Replacement
STAR Total Ankle Replacement
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients (age \> 18 years) who will benefit from a total ankle replacement, as determined by Drs. Nunley, DeOrio, or Easley, with the aid of the physical exam and routine radiography treated at Duke University Medical Center and who have no medical conditions that would represent contraindications to surgery or anesthesia will be asked to participate in this study.
Exclusion criteria
* The only excluded patients will be those who do not choose to participate in this study, have a weight greater than 250lbs, or do not meet the minimum age of 18 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Following a Total Ankle Replacement as Measured by the Visual Analog Scale (VAS) for Pain | Baseline, 6 months, 1 year, 2 years, 3 years | 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 |
| Functional Health Following a Total Ankle Replacement Using the 36-Item Short Form Health Survey (SF-36). | Baseline, 6 months, 1 year, 2 years, 3 years | 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 |
| Physical Limitations Following a Total Ankle Replacement as Measured by the Short Musculoskeletal Function Assessment (SMFA) Questionnaire. | Baseline, 6 months, 1 year, 2 years, 3 years | 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. |
| Pain and Function Following a Total Ankle Replacement as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Rating System | Baseline, 6 months, 1 year, 2 years, 3 years | 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. |
| 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. | Baseline, 6 months, 1 year, 2 years, 3 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Three Dimensional Kinematic and Kinetic Assessment During Level Walking Across Time Following Total Ankle Replacement. | Baseline, 6 months, 1 year, 2 years, 3 years | 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. |
Countries
United States
Participant flow
Pre-assignment details
Two subjects were not randomized.
Participants by arm
| Arm | Count |
|---|---|
| Salto-Talaris Total Ankle Replacement Salto-Talaris Total Ankle Replacement surgery | 37 |
| STAR Total Ankle Replacement STAR Total Ankle Replacement: STAR Total Ankle Replacement | 37 |
| Total | 74 |
Baseline characteristics
| Characteristic | Salto-Talaris Total Ankle Replacement | STAR Total Ankle Replacement | Total |
|---|---|---|---|
| Age, Continuous | 65.83 years STANDARD_DEVIATION 11.2 | 65.64 years STANDARD_DEVIATION 8.17 | 65.73 years STANDARD_DEVIATION 9.68 |
| Diabetes No | 34 Participants | 29 Participants | 63 Participants |
| Diabetes Yes | 3 Participants | 6 Participants | 9 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 33 Participants | 34 Participants | 67 Participants |
| Region of Enrollment United States | 37 Participants | 37 Participants | 74 Participants |
| Sex: Female, Male Female | 22 Participants | 32 Participants | 54 Participants |
| Sex: Female, Male Male | 15 Participants | 5 Participants | 20 Participants |
| Smoking status Current | 2 Participants | 0 Participants | 2 Participants |
| Smoking status Former | 18 Participants | 15 Participants | 33 Participants |
| Smoking status Never | 17 Participants | 20 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 1 / 50 |
| other Total, other adverse events | 0 / 48 | 0 / 50 |
| serious Total, serious adverse events | 0 / 48 | 1 / 50 |
Outcome results
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
Time frame: Baseline, 6 months, 1 year, 2 years, 3 years
Population: Data not collected at 3 years.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Salto-Talaris Total Ankle Replacement | Functional Health Following a Total Ankle Replacement Using the 36-Item Short Form Health Survey (SF-36). | 1 year | 71.4 score on a scale | Standard Deviation 18.7 |
| Salto-Talaris Total Ankle Replacement | Functional Health Following a Total Ankle Replacement Using the 36-Item Short Form Health Survey (SF-36). | Baseline | 69.1 score on a scale | Standard Deviation 19.3 |
| Salto-Talaris Total Ankle Replacement | Functional Health Following a Total Ankle Replacement Using the 36-Item Short Form Health Survey (SF-36). | 2 years | 77.1 score on a scale | Standard Deviation 17.3 |
| Salto-Talaris Total Ankle Replacement | Functional Health Following a Total Ankle Replacement Using the 36-Item Short Form Health Survey (SF-36). | 6 months | 47.7 score on a scale | Standard Deviation 17.4 |
| STAR | Functional Health Following a Total Ankle Replacement Using the 36-Item Short Form Health Survey (SF-36). | 2 years | 69.5 score on a scale | Standard Deviation 21.6 |
| STAR | Functional Health Following a Total Ankle Replacement Using the 36-Item Short Form Health Survey (SF-36). | 1 year | 70.7 score on a scale | Standard Deviation 21.2 |
| STAR | Functional Health Following a Total Ankle Replacement Using the 36-Item Short Form Health Survey (SF-36). | 6 months | 51.4 score on a scale | Standard Deviation 19.1 |
| STAR | Functional Health Following a Total Ankle Replacement Using the 36-Item Short Form Health Survey (SF-36). | Baseline | 67.4 score on a scale | Standard Deviation 22.1 |
p-value: 0.31ANOVA
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.
Time frame: Baseline, 6 months, 1 year, 2 years, 3 years
Population: Data not collected at 3 years.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Salto-Talaris Total Ankle Replacement | Pain and Function Following a Total Ankle Replacement as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Rating System | Baseline | 44.6 score on a scale | Standard Deviation 14.9 |
| Salto-Talaris Total Ankle Replacement | Pain and Function Following a Total Ankle Replacement as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Rating System | 6 months | 80.2 score on a scale | Standard Deviation 13.5 |
| Salto-Talaris Total Ankle Replacement | Pain and Function Following a Total Ankle Replacement as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Rating System | 1 year | 84.5 score on a scale | Standard Deviation 9.9 |
| Salto-Talaris Total Ankle Replacement | Pain and Function Following a Total Ankle Replacement as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Rating System | 2 years | 84.5 score on a scale | Standard Deviation 9.3 |
| STAR | Pain and Function Following a Total Ankle Replacement as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Rating System | 2 years | 64.7 score on a scale | Standard Deviation 23.7 |
| STAR | Pain and Function Following a Total Ankle Replacement as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Rating System | Baseline | 46.4 score on a scale | Standard Deviation 17.9 |
| STAR | Pain and Function Following a Total Ankle Replacement as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Rating System | 1 year | 78.0 score on a scale | Standard Deviation 12.9 |
| STAR | Pain and Function Following a Total Ankle Replacement as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Rating System | 6 months | 76.1 score on a scale | Standard Deviation 17.3 |
p-value: 0.04ANOVA
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
Time frame: Baseline, 6 months, 1 year, 2 years, 3 years
Population: Data not collected at 3 years.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Salto-Talaris Total Ankle Replacement | Pain Following a Total Ankle Replacement as Measured by the Visual Analog Scale (VAS) for Pain | Baseline | 67.0 mm | Standard Deviation 25.9 |
| Salto-Talaris Total Ankle Replacement | Pain Following a Total Ankle Replacement as Measured by the Visual Analog Scale (VAS) for Pain | 2 years | 12.4 mm | Standard Deviation 19.4 |
| Salto-Talaris Total Ankle Replacement | Pain Following a Total Ankle Replacement as Measured by the Visual Analog Scale (VAS) for Pain | 6 months | 16.7 mm | Standard Deviation 22.9 |
| Salto-Talaris Total Ankle Replacement | Pain Following a Total Ankle Replacement as Measured by the Visual Analog Scale (VAS) for Pain | 1 year | 12.0 mm | Standard Deviation 19.1 |
| STAR | Pain Following a Total Ankle Replacement as Measured by the Visual Analog Scale (VAS) for Pain | 2 years | 23.5 mm | Standard Deviation 28.7 |
| STAR | Pain Following a Total Ankle Replacement as Measured by the Visual Analog Scale (VAS) for Pain | Baseline | 71.3 mm | Standard Deviation 21.4 |
| STAR | Pain Following a Total Ankle Replacement as Measured by the Visual Analog Scale (VAS) for Pain | 1 year | 16.9 mm | Standard Deviation 20.8 |
| STAR | Pain Following a Total Ankle Replacement as Measured by the Visual Analog Scale (VAS) for Pain | 6 months | 18.6 mm | Standard Deviation 20 |
p-value: 0.29ANOVA
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.
Time frame: Baseline, 6 months, 1 year, 2 years, 3 years
Population: Data not collected at 3 years.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Salto-Talaris Total Ankle Replacement | Physical Limitations Following a Total Ankle Replacement as Measured by the Short Musculoskeletal Function Assessment (SMFA) Questionnaire. | 1 year | 51.5 score on a scale | Standard Deviation 12.6 |
| Salto-Talaris Total Ankle Replacement | Physical Limitations Following a Total Ankle Replacement as Measured by the Short Musculoskeletal Function Assessment (SMFA) Questionnaire. | 6 months | 54.9 score on a scale | Standard Deviation 14.7 |
| Salto-Talaris Total Ankle Replacement | Physical Limitations Following a Total Ankle Replacement as Measured by the Short Musculoskeletal Function Assessment (SMFA) Questionnaire. | 2 years | 48.5 score on a scale | Standard Deviation 12.9 |
| Salto-Talaris Total Ankle Replacement | Physical Limitations Following a Total Ankle Replacement as Measured by the Short Musculoskeletal Function Assessment (SMFA) Questionnaire. | Baseline | 83.0 score on a scale | Standard Deviation 19.2 |
| STAR | Physical Limitations Following a Total Ankle Replacement as Measured by the Short Musculoskeletal Function Assessment (SMFA) Questionnaire. | 2 years | 56.1 score on a scale | Standard Deviation 18.9 |
| STAR | Physical Limitations Following a Total Ankle Replacement as Measured by the Short Musculoskeletal Function Assessment (SMFA) Questionnaire. | 6 months | 60.4 score on a scale | Standard Deviation 18.7 |
| STAR | Physical Limitations Following a Total Ankle Replacement as Measured by the Short Musculoskeletal Function Assessment (SMFA) Questionnaire. | 1 year | 57.1 score on a scale | Standard Deviation 15.6 |
| STAR | Physical Limitations Following a Total Ankle Replacement as Measured by the Short Musculoskeletal Function Assessment (SMFA) Questionnaire. | Baseline | 80.3 score on a scale | Standard Deviation 19.5 |
p-value: 0.07ANOVA
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.
Time frame: Baseline, 6 months, 1 year, 2 years, 3 years
Population: Data not collected at 3 years.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Salto-Talaris Total Ankle Replacement | 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. | 1 year | 20.1 score on a scale | Standard Deviation 21.5 |
| Salto-Talaris Total Ankle Replacement | 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. | Baseline | 55.1 score on a scale | Standard Deviation 18.9 |
| Salto-Talaris Total Ankle Replacement | 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. | 6 months | 8.0 score on a scale | Standard Deviation 11.3 |
| Salto-Talaris Total Ankle Replacement | 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. | 2 years | 16.0 score on a scale | Standard Deviation 15.1 |
| STAR | 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. | 2 years | 18.0 score on a scale | Standard Deviation 18.7 |
| STAR | 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. | 1 year | 26.2 score on a scale | Standard Deviation 13.7 |
| STAR | 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. | 6 months | 51.5 score on a scale | Standard Deviation 17.7 |
| STAR | 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. | Baseline | 51.6 score on a scale | Standard Deviation 13.3 |
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.
Time frame: Baseline, 6 months, 1 year, 2 years, 3 years
Population: Data not collected.