Splinting Versus Not Splinting of the Distal Lower Extremity After Intramedullary Nailing for Tibial Fractures
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|ClinicalTrials.gov Identifier: NCT00888550|
Recruitment Status : Completed
First Posted : April 27, 2009
Last Update Posted : September 29, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Tibia Fracture||Procedure: Post-Op Splinting Procedure: No Splinting||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomized Trial of Post-Operative Outcomes: Splinting Versus Not Splinting of the Distal Lower Extremity After Intramedullary Nailing for Tibial Fractures|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
|Experimental: 1. Splinting||
Procedure: Post-Op Splinting
Splint will applied post-operatively and will remain on for two weeks
|Active Comparator: 2. No Splinting||
Procedure: No Splinting
Patient will be discharged post-operatively without a splint on their lower leg.
- Differences across time and between groups for pain and range of motion [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00888550
|United States, Colorado|
|Denver Health Medical Center|
|Denver, Colorado, United States, 80204|