Total Ankle Replacement for Ankle Arthritis

NCT01986244 | Completed

• 1 other identifier: Pro00001600
• Study Type: observational
• Target: 1,043
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to prospectively evaluate the functional outcome and patient satisfaction of total ankle replacement for tibio-talar osteoarthritis.

Conditions

Ankle Osteoarthritis

Keywords

Osteoarthritis; Arthritis; Joint Diseases

Outcome Measures

Primary Outcomes (5)

• Change in Visual Analog Pain Scale (VAS)

  To assess changes in pain across time following total ankle replacement across multiple time points. A visual analog scale of pain is an instrument used to measure the amount of pain a patient feels.

  Preoperatively, 1yr, 2yr, 5yr, and 10yr

• Change in Short Form Health Survey

  To assess functional health and well being across time following total ankle replacement and to determine if there are significant differences.

  Preoperatively, 1yr, 2yr, 5yr, and 10yr

• Change in Short Musculoskeletal Function Assessment (SMFA)

  SMFA is an outcome measure to provide a standardized measure of the actual physical limitations of the patient.

  Preoperatively, 1yr, 2yr, 5yr, and 10yr

• Change in AOFAS Hindfoot Scale questionnaire

  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.

  Preoperatively, 1yr, 2yr, 5yr, and 10yr

• Change in Foot and Ankle Disability Index (FADI)

  Patient reported function outcomes during activities of daily living.

  Preoperatively, 1yr, 2yr, 5yr, and 10yr

Secondary Outcomes (1)

• Changes in Three dimensional kinematic and kinetic assessments during level walking

  preoperatively, 1yr, 2yr, 5yr, and 10yr

Study Arms (3)

STAR Total Ankle Replacement

Procedure: Total Ankle Replacement Surgery using the STAR

Salto Talaris Total Ankle Replacement

Procedure: Total Ankle Replacement Surgery using the Salto Talaris

In-Bone Total Ankle Replacement

Procedure: Total Ankle Replacement Surgery using the In-Bone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who will benefit from a total ankle replacement.

You may qualify if:

• Adult patients (age \> 18 years) who will benefit from a total ankle replacement, as determined by Drs. Nunley, DeOrio, Easley, or Adams, with the aid of the physical exam and routine radiography
• Treated at Duke University Medical Center
• Patients who have no medical conditions that would represent contraindications to surgery or anesthesia

You may not qualify if:

• Patients who do not meet the minimum age of 18 years.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Medical Plaza Page Road

Durham, North Carolina, 27703, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis; Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• James A Nunley, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 18, 2013
• Study Start: June 13, 2007
• Primary Completion: November 5, 2019
• Study Completion: November 5, 2019
• Last Updated: May 6, 2020

Record last verified: 2020-05

Locations

US (1)