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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00888550
Other study ID # DHMC07-0216
Secondary ID
Status Completed
Phase N/A
First received April 23, 2009
Last updated September 28, 2010
Start date August 2007
Est. completion date December 2009

Study information

Verified date September 2010
Source Denver Health and Hospital Authority
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Post-Op Splinting
Splint will applied post-operatively and will remain on for two weeks
No Splinting
Patient will be discharged post-operatively without a splint on their lower leg.

Locations

Country Name City State
United States Denver Health Medical Center Denver Colorado

Sponsors (1)

Lead Sponsor Collaborator
Denver Health and Hospital Authority

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Differences across time and between groups for pain and range of motion 3 months No
See also
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