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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01504438
First Posted: January 5, 2012
Last Update Posted: March 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Duke University
  Purpose
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 Intervention
Ankle Osteoarthritis Device: Salto-Talaris Total Ankle Replacement Device: STAR Total Ankle Replacement

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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, and 3yr ]
    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.

  • 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: peroperative, 6month, 1yr, 2yr, and 3yr ]
    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

  • 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, 6month, 1yr, 2yr, and 3yr ]
    SMFA is an outcome measure to provide a standardized measure of the actual physical limitations of the patient.

  • 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: Peroperatively, 6month, 1yr, 2yr, and 3yr ]
    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.

  • 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, 6month, 1yr, 2yr, and 3yr ]
    Patient reported function outcomes during activities of daily living.


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


Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01504438     History of Changes
Other Study ID Numbers: Pro00031027
First Submitted: October 10, 2011
First Posted: January 5, 2012
Last Update Posted: March 24, 2017
Last Verified: March 2017

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