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

NCT01504438 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-05-05

Study results available
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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.

Conditions

  • Ankle Osteoarthritis

Interventions

DEVICE

Salto-Talaris Total Ankle Replacement

Salto-Talaris Total ankle replacement surgery

DEVICE

STAR Total Ankle Replacement

STAR Total Ankle Replacement

Sponsors & Collaborators

Principal Investigators

  • James A Nunley, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2020-03-04
Completion
2020-03-04

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01504438 on ClinicalTrials.gov