N/A
N=98
Prospective Randomized Evaluation of a Two and Three Piece Total Ankle Replacement
Ankle Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01504438 ↗Enrolled (actual)
98
Serious AEs
1.0%
Results posted
May 2021
Primary outcome: Primary: Pain Following a Total Ankle Replacement as Measured by the Visual Analog Scale (VAS) for Pain — 67.0; 71.3; 16.7; 18.6 mm — p=0.29
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Salto-Talaris Total Ankle Replacement (Device); STAR Total Ankle Replacement (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Following a Total Ankle Replacement as Measured by the Visual Analog Scale (VAS) for Pain |
67.0; 71.3; 16.7; 18.6; 12.0; 16.9 | 0.29 |
| PRIMARY Functional Health Following a Total Ankle Replacement Using the 36-Item Short Form Health Survey (SF-36). |
69.1; 67.4; 47.7; 51.4; 71.4; 70.7 | 0.31 |
| PRIMARY Physical Limitations Following a Total Ankle Replacement as Measured by the Short Musculoskeletal Function Assessment (SMFA) Questionnaire. |
83.0; 80.3; 54.9; 60.4; 51.5; 57.1 | 0.07 |
| PRIMARY Pain and Function Following a Total Ankle Replacement as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Rating System |
44.6; 46.4; 80.2; 76.1; 84.5; 78.0 | 0.04 sig |
| 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. |
55.1; 51.6; 8.0; 51.5; 20.1; 26.2 | — |
| SECONDARY Three Dimensional Kinematic and Kinetic Assessment During Level Walking Across Time Following Total Ankle Replacement. |
— | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01504438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.