NCT00919464

Brief Summary

This study is to determine the natural history of compartment pressures in the anterior thigh secondary to a fracture of the femoral shaft.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable

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

April 1, 2006

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

3.8 years

First QC Date

June 9, 2009

Last Update Submit

March 2, 2020

Conditions

Femur Fracture

Keywords

Compartment pressurecompartment syndromefemur fracture

Outcome Measures

Primary Outcomes (1)

  • Compartment pressures

    Pre-operative to 50 hours post operation

Study Arms (1)

Needle Insertion into Femur

OTHER

Data gathering with monitoring of pressures in the thigh via via needle in femur.

Device: Pressure monitoring deviceDevice: Compartmental fracture pressure monitoringDevice: This small project is designed to be a non-randomized, investigational prospective trial of compartment pressures in the thigh following femoral fracture

Interventions

Pressure monitoring deviceDEVICE

monitoring device inserted to measure thigh compartment pressures

Needle Insertion into Femur
Compartmental fracture pressure monitoringDEVICE
Needle Insertion into Femur
This small project is designed to be a non-randomized, investigational prospective trial of compartment pressures in the thigh following femoral fractureDEVICE
Needle Insertion into Femur

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • femur fracture
  • age 18 and older

You may not qualify if:

  • patients who are not candidates for surgical repair of femur fracture
  • patients not expected to survive more than 1 week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Femoral FracturesCompartment Syndromes

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg InjuriesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • John DeLuca, MD

    WVU Department of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
IRB Admin

Study Record Dates

First Submitted

June 9, 2009

First Posted

June 12, 2009

Study Start

April 1, 2006

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

March 4, 2020

Record last verified: 2020-03