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Study of the Scandinavian Total Ankle Replacement (STAR) for the Treatment of Bilateral Degenerative Ankle Disease

NCT00586781 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2008-01-04

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety of the S.T.A.R. device for patients with bilateral disease.

Conditions

Interventions

DEVICE

Scandinavian Total Ankle Replacement (STAR)

The device has three parts: two metal bearing surfaces (cobalt-chromium alloy) plates with bars that fit into the bone and one plastic (polyethylene) spacer that moves between the metal plates like a ball bearing. The materials in the S.T.A.R. device are the same materials used in total hip and knee implants.

Sponsors & Collaborators

  • Link America, Inc.

    lead INDUSTRY

Principal Investigators

  • Roger A Mann, MD · Roger A Mann, Inc

  • Michael J Coughlin, MD · Foot and Ankle

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-09-30
Primary Completion
2006-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00586781 on ClinicalTrials.gov