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

NCT ID: NCT00888550

Last Updated: 2010-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tibia Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1. Splinting

Group Type EXPERIMENTAL

Post-Op Splinting

Intervention Type PROCEDURE

Splint will applied post-operatively and will remain on for two weeks

2. No Splinting

Group Type ACTIVE_COMPARATOR

No Splinting

Intervention Type PROCEDURE

Patient will be discharged post-operatively without a splint on their lower leg.

Interventions

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Post-Op Splinting

Splint will applied post-operatively and will remain on for two weeks

Intervention Type PROCEDURE

No Splinting

Patient will be discharged post-operatively without a splint on their lower leg.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Isolated tibia fracture that is open grade II or less and all closed tibia fractures that are amenable to treatment with an IM nail

Exclusion Criteria

* Pregnant Women
* Prisoners
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Denver Health and Hospital Authority

OTHER

Sponsor Role lead

Responsible Party

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Denver Health Medical Center

Locations

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Denver Health Medical Center

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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DHMC07-0216

Identifier Type: -

Identifier Source: org_study_id