Splinting Versus Not Splinting of the Distal Lower Extremity After Intramedullary Nailing for Tibial Fractures
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized Trial of Post-Operative Outcomes: Splinting Versus Not Splinting of the Distal Lower Extremity After Intramedullary Nailing for Tibial Fractures|
- Differences across time and between groups for pain and range of motion [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888550
|United States, Colorado|
|Denver Health Medical Center|
|Denver, Colorado, United States, 80204|