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

Duke University

Status: Completed

Conditions: Ankle Osteoarthritis

Treatments: Device: Salto-Talaris Total Ankle Replacement; Device: STAR Total Ankle Replacement

Study type: Interventional

Funder types: Other

Identifiers

NCT01504438

Pro00031027

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Salto Talaris Total Ankle Replacement

Other group

Treatment:

Device: Salto-Talaris Total Ankle Replacement

STAR Total Ankle Replacement

Other group

Treatment:

Device: STAR Total Ankle Replacement