NCT01444144

Brief Summary

The purpose of this study is to track surgical outcomes and post-operative course in patients 55 years of age or older treated for ankle fractures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2011

Completed
Last Updated

October 3, 2017

Status Verified

September 1, 2017

Enrollment Period

1 month

First QC Date

September 26, 2011

Last Update Submit

September 29, 2017

Conditions

Keywords

AnkleFractureElderlyAt-risk PopulationAnkle Fracture in at-risk elderly population

Outcome Measures

Primary Outcomes (1)

  • Status of Fracture Union

    Retrospective records review tracking ankle fractures post-operatively until fracture heals.

    Post-operatively until documentation of fracture healing, assessed up to seven months following surgery.

Secondary Outcomes (1)

  • Post-operative Complications

    Post-operatively until documentation that complications resolved, assessed up to seven months following surgery.

Study Arms (1)

Ankle Fracture

Patients aged 55 years at time of surgery undergoing treatment for ankle fractures.

Other: Fracture union

Interventions

Retrospective records review post-operatively until fracture resolved.

Ankle Fracture

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

At-risk population, at least 55 years of age at time of surgery receiving treatment for ankle fractures.

You may qualify if:

  • at least 55 years of age at time of surgery
  • receiving treatment for ankle fractures

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF&Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607, United States

Location

MeSH Terms

Conditions

Ankle FracturesFractures, Bone

Condition Hierarchy (Ancestors)

Wounds and InjuriesAnkle InjuriesLeg Injuries

Study Officials

  • Kalia K Sadasivan, M.D.

    University of Florida Department of Orthopaedics and Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 26, 2011

First Posted

September 30, 2011

Study Start

March 1, 2011

Primary Completion

April 3, 2011

Study Completion

April 3, 2011

Last Updated

October 3, 2017

Record last verified: 2017-09

Locations