NCT01612962

Brief Summary

In this study, the investigators will perform a retrospective chart analysis of patients that underwent a bony debridement or amputation in the operating room at Georgetown University Hospital during 2009-2010 under Drs. Steinberg and Attinger. Chart reviews, medical records and operative reports via EMR and paper charts will be examined from inpatient records, the Center for Wound Healing, the Emergency Department as well as other institutions involved in the care of the subjects to gather data.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
196

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2011

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

May 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 6, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 6, 2015

Status Verified

February 1, 2014

Enrollment Period

3.8 years

First QC Date

May 30, 2012

Last Update Submit

February 5, 2015

Conditions

Osteomyelitis

Outcome Measures

Primary Outcomes (1)

  • Accuracy of Osteomyelitis Diagnostic Testing

    The purpose of this study is to help compare accuracy of all the diagnostic tests that are used in current practice to help determine osteomyelitis.

    12 months

Secondary Outcomes (1)

  • Reliability of diagnostic testing for Osteomyelitis

    12 months

Study Arms (1)

bony debridement or amputation

In this study, the investigators will perform a retrospective chart analysis of patients that underwent a bony debridement or amputation in the operating room at Georgetown University Hospital during 2009-2010 under Drs. Steinberg and Attinger

Eligibility Criteria

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

Patients that underwent a bony debridement or amputation in the operating room at Georgetown University Hospital during 2009-2010 under Drs. Steinberg and Attinger

You may qualify if:

  • Patients that underwent a bony debridement or amputation in the operating room at Georgetown University Hospital during 2009-2010 under Drs. Steinberg and Attinger

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Osteomyelitis

Condition Hierarchy (Ancestors)

Bone Diseases, InfectiousInfectionsBone DiseasesMusculoskeletal Diseases

Study Officials

  • John J. Steinberg, DPM

    Georgetown University Hospital

    PRINCIPAL INVESTIGATOR

  • Paul Kim, DPM

    Georgetown University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 30, 2012

First Posted

June 6, 2012

Study Start

May 1, 2011

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 6, 2015

Record last verified: 2014-02

Locations

US(1)