Clinical Trials Directory

Trials / Completed

CompletedNCT00888550

Splinting Versus Not Splinting of the Distal Lower Extremity After Intramedullary Nailing for Tibial Fractures

A Randomized Trial of Post-Operative Outcomes: Splinting Versus Not Splinting of the Distal Lower Extremity After Intramedullary Nailing for Tibial Fractures

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
Denver Health and Hospital Authority · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

Two standards of care exist with regards to posterior splinting post-operatively. The proponents of splinting feel the additional immobilization decreases the stress on the soft tissue, subsequently preventing or limiting pain while improving early range of motion (ROM). The opposing belief is that the splinting is without therapeutic benefit and that early mobilization is beneficial. With regards to both practices, the surgeon's practice is anecdotally based on past experience. The purpose of this study is to compare the results obtained with and without posterior splinting after intramedullary (IM) nailing for tibia fractures in order to provide evidence based reasoning to guide future practice.

Conditions

Interventions

TypeNameDescription
PROCEDUREPost-Op SplintingSplint will applied post-operatively and will remain on for two weeks
PROCEDURENo SplintingPatient will be discharged post-operatively without a splint on their lower leg.

Timeline

Start date
2007-08-01
Primary completion
2009-12-01
Completion
2009-12-01
First posted
2009-04-27
Last updated
2010-09-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00888550. Inclusion in this directory is not an endorsement.

Splinting Versus Not Splinting of the Distal Lower Extremity After Intramedullary Nailing for Tibial Fractures (NCT00888550) · Clinical Trials Directory