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

NCT ID: NCT01504438

Last Updated: 2021-05-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2020-03-04

Brief Summary

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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.

Detailed Description

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Conditions

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Ankle Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Salto Talaris Total Ankle Replacement

Group Type OTHER

Salto-Talaris Total Ankle Replacement

Intervention Type DEVICE

Salto-Talaris Total ankle replacement surgery

STAR Total Ankle Replacement

Group Type OTHER

STAR Total Ankle Replacement

Intervention Type DEVICE

STAR Total Ankle Replacement

Interventions

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Salto-Talaris Total Ankle Replacement

Salto-Talaris Total ankle replacement surgery

Intervention Type DEVICE

STAR Total Ankle Replacement

STAR Total Ankle Replacement

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James A Nunley, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke Medical Plaza Page Road

Durham, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Pro00031027

Identifier Type: -

Identifier Source: org_study_id

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