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Prospective Randomized Evaluation of a Two and Three Piece Total Ankle Replacement

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ClinicalTrials.gov Identifier: NCT01504438
Recruitment Status : Active, not recruiting
First Posted : January 5, 2012
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Ankle Osteoarthritis Device: Salto-Talaris Total Ankle Replacement Device: STAR Total Ankle Replacement Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Evaluation Of A Two And Three Piece Total Ankle Replacement
Study Start Date : October 2011
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
Salto Talaris Total Ankle Replacement Device: Salto-Talaris Total Ankle Replacement
Salto-Talaris Total ankle replacement surgery
STAR Total Ankle Replacement Device: STAR Total Ankle Replacement
STAR Total Ankle Replacement



Primary Outcome Measures :
  1. To measure a change in one's pain following a Total Ankle Replacement using the Visual Analog Pain Scale (VAS)across multiple time points. [ Time Frame: Preoperatively, 6months, 1yr, 2yr, 3yr, 4 yr, and 5 yr ]
    To assess changes in pain across time following total ankle replacement. A visual analog scale of pain is an instrument used to measure the amount of pain a patient feels.

  2. To measure a change in one's functional health following a Total Ankle Replacement using Short Form Health Survey at multiple time points. [ Time Frame: Preoperatively, 6months, 1yr, 2yr, 3yr, 4 yr, and 5 yr ]
    To assess functional health and well being across time following total ankle replacement and to determine if there is a significant difference between the STAR and Salto-Talaris

  3. To measure a change in one's physical limitations following a Total Ankle Replacement using the short musculoskeletal function assessment (SMFA)questionnaire at multiple time points. [ Time Frame: Preoperatively, 6months, 1yr, 2yr, 3yr, 4 yr, and 5 yr ]
    SMFA is an outcome measure to provide a standardized measure of the actual physical limitations of the patient.

  4. To measure a change in one's pain and function following a Total Ankle Replacement using the AOFAS Hindfoot Scale questionnaires at multiple time points. [ Time Frame: Preoperatively, 6months, 1yr, 2yr, 3yr, 4 yr, and 5 yr ]
    The AOFAS combines subjective scores of pain and function provided by the patient with objective scores based on the surgeon's physical examination of the patient.

  5. 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. [ Time Frame: Preoperatively, 6months, 1yr, 2yr, 3yr, 4 yr, and 5 yr ]
    Patient reported function outcomes during activities of daily living.


Secondary Outcome Measures :
  1. Change in Three dimensional kinematic and kinetic assessment during level walking across time following total ankle replacement. [ Time Frame: Preoperatively, 6months, 1yr, 2yr, 3yr, 4 yr, and 5 yr ]
    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.



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504438


Locations
United States, North Carolina
Duke Medical Plaza Page Road
Durham, North Carolina, United States, 27703
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: James A Nunley, MD Duke University

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01504438     History of Changes
Other Study ID Numbers: Pro00031027
First Posted: January 5, 2012    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases