NCT01366989

Brief Summary

The primary objective of this study is to evaluate the radiographic outcomes of Total Ankle Arthroplasty in patients having a calcaneal stem.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

October 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2013

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

2.7 years

First QC Date

June 2, 2011

Last Update Submit

February 15, 2017

Conditions

ArthrodesisDegenerative ArthritisRheumatoid ArthritisComplications; Arthroplasty, Mechanical

Keywords

Total Ankle Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Radiographic Evaluation

    Bone quality of the talus, navicular, and cuboid will be assessed on both the lateral and mortise views of the latest follow-up radiographs

    Post operarative 1.2 -3.1 years

Study Arms (1)

Total Ankle Arthroplasty with calcaneal stem

Patients received the TAA with calcaneal stem between 12/6/05 \& 11/13/07 at approximately 28 sites.

Device: Radiographic evaluation of previously implanted patients

Interventions

Radiographic evaluation of previously implanted patientsDEVICE

Radiographs of the ankle

Also known as: Radiographs of previously implanted patients
Total Ankle Arthroplasty with calcaneal stem

Eligibility Criteria

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

Patients who will be recruited for participation in this study received the TAA with calcaneal stem between December 6, 2005 and November 13, 2007 at approximately 28 sites.

You may qualify if:

  • Patients who will be recruited for participation in this study received the TAA with calcaneal stem between December 6, 2005 and November 13, 2007 at approximately 28 sites.

You may not qualify if:

  • Patients who will be recruited for participation in this study received the TAA with calcaneal stem between December 6, 2005 and November 13, 2007 at approximately 28 sites.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael Bolognesi, MD

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

AnkylosisOsteoarthritisArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesArthritisRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Michael Bolognesi, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2011

First Posted

June 6, 2011

Study Start

October 1, 2010

Primary Completion

June 4, 2013

Study Completion

June 4, 2013

Last Updated

February 17, 2017

Record last verified: 2017-02

Locations

US(1)