NCT00842101

Brief Summary

The purpose of this study is to determine the effect of reamed intramedullary nails in tibial shaft fractures (as a standard treatment), in raising intracompartmental pressures and therefore determine if they are a risk factor for compartmental syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2005

Typical duration 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

December 1, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
Last Updated

February 12, 2009

Status Verified

February 1, 2009

Enrollment Period

2.3 years

First QC Date

February 10, 2009

Last Update Submit

February 11, 2009

Conditions

Tibial Fractures

Keywords

Intramedullary nailsCompartmental syndromeFractures

Outcome Measures

Primary Outcomes (1)

  • intracompartmental pressures

    0-2 hours

Study Arms (1)

pressure monitor

Tibial Fracture

Device: Quick Pressure Monitor

Interventions

Quick Pressure MonitorDEVICE

The monitor measures actively the actual pressure inside the compartment affected.

Also known as: Slit catheter
pressure monitor

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with tibial shaft fractures

You may qualify if:

  • Tibial shaft fractures treated with intramedullary reamed nails

You may not qualify if:

  • Tibial fractures treated with other types of fixation or nails not reamed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic and Trauma Unit. Nostra Senyora de Meritxell Hospital

Les Escaldes, AD700, Andorra

Location

Biospecimen

Retention: NONE RETAINED

Serum

MeSH Terms

Conditions

Tibial FracturesCompartment SyndromesFractures, Bone

Condition Hierarchy (Ancestors)

Wounds and InjuriesLeg InjuriesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • JOSE I TORRERO, M.D.

    Orthopaedic and Trauma Unit. Andorra´s Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 12, 2009

Study Start

December 1, 2005

Primary Completion

April 1, 2008

Study Completion

September 1, 2008

Last Updated

February 12, 2009

Record last verified: 2009-02

Locations

AN(1)