Trials Sponsors Conditions Drugs Pricing

Conditions

Osteoarthritis Post-Traumatic Arthritis Rheumatoid Arthritis

Keywords

ankle replacementend-stage arthritis of the ankledegenerative ankle disease

Outcome Measures

Primary Outcomes (1)

Safety endpoints to be measured are: • Device failure or device removal/revision • Radiographically confirmed loosening and migration • Complications
12 months

Study Arms (1)

3

EXPERIMENTAL

The S.T.A.R. ankle system is the study device. 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. Both ankles of every subject will be treated with the STAR ankle.

Device: Scandinavian Total Ankle Replacement (STAR)

Interventions

Scandinavian Total Ankle Replacement (STAR)Device

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.

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Moderate or severe pain, loss of mobility and function of the ankle
Primary arthrosis, post traumatic arthrosis or rheumatoid arthrosis

Sponsors & Collaborators

Link America, Inc.
Industrylead

Study Sites (5)

Mayo Clinic

Jacksonville, Florida, 32224, United States

University of Iowa

Iowa City, Iowa, 52242, United States

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Duke University Medical Center

Durham, North Carolina, 27710, United States

Orthopedic Associates of Dallas

Dallas, Texas, 75246, United States

MeSH Terms

Conditions

OsteoarthritisArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

Roger A Mann, MD
Roger A Mann, Inc
PRINCIPAL INVESTIGATOR
Michael J Coughlin, MD
Foot and Ankle
PRINCIPAL INVESTIGATOR

Enrollment

21 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 4, 2008

Study Start

September 2001

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations