NCT01818466

Brief Summary

The aim of this study is to evaluate the clinical and radiographic outcomes of patients who have previously undergone tibiotalar arthrodesis using an anterior approach with blade-plate fixation for tibiotalar arthritis secondary to injury to the articular surface of the distal tibia.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2012

Typical duration for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 26, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 28, 2016

Status Verified

June 1, 2016

Enrollment Period

3.5 years

First QC Date

February 5, 2013

Last Update Submit

June 27, 2016

Conditions

Pilon FractureArthritis

Outcome Measures

Primary Outcomes (1)

  • Outcome Questionnaires relating to the patients current condition

    These questionnaires will include the FAOS, FADI, SF-36, PromisCAT, SMFA, and the DRAM.

    1 Year after Surgery

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have previously undergone tibiotalar arthrodesis using an anterior approach with blade-plate fixation for tibiotalar arthritis secondary to injury to the articular surface of the distal tibia.

You may not qualify if:

  • Any patient who is not 18 years of age or older will not be eligible for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Thomas Higgins, MD

    Orthopedic Surgery Operations

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

February 5, 2013

First Posted

March 26, 2013

Study Start

November 1, 2012

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 28, 2016

Record last verified: 2016-06