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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00888550
First Posted: April 27, 2009
Last Update Posted: September 29, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Denver Health and Hospital Authority
  Purpose

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 Intervention
Tibia Fracture Procedure: Post-Op Splinting Procedure: No Splinting

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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

Resource links provided by NLM:


Further study details as provided by Denver Health and Hospital Authority:

Primary Outcome Measures:
  • Differences across time and between groups for pain and range of motion [ Time Frame: 3 months ]

Estimated Enrollment: 20
Study Start Date: August 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Denver Health and Hospital Authority
  More Information

Responsible Party: Steven Morgan, MD, Denver Health Medical Center
ClinicalTrials.gov Identifier: NCT00888550     History of Changes
Other Study ID Numbers: DHMC07-0216
First Submitted: April 23, 2009
First Posted: April 27, 2009
Last Update Posted: September 29, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries