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

This study is currently recruiting participants.
Verified November 2012 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01504438
First received: October 10, 2011
Last updated: November 15, 2012
Last verified: November 2012
History of Changes
  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 Phase
Ankle Osteoarthritis
 Other: Total Ankle Replacement Surgery
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Evaluation Of A Two And Three Piece Total Ankle Replacement

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: 80
Study Start Date: October 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Salto Talaris Total Ankle Replacement Other: Total Ankle Replacement Surgery
Total ankle replacement surgery
STAR Total Ankle Replacement Other: Total Ankle Replacement Surgery
Total ankle replacement surgery

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01504438

Contacts
Contact: Jennifer K Friend, AS 919-668-4373 jennifer.friend@duke.edu

Locations
United States, North Carolina
Duke Medical Plaza Page Road Recruiting
Durham, North Carolina, United States, 27703
Contact: Jennifer K Friend, AS     919-668-4373     jennifer.friend@duke.edu    
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: James A Nunley, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01504438     History of Changes
Other Study ID Numbers: Pro00031027
Study First Received: October 10, 2011
Last Updated: November 15, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013