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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:
Information provided by:
Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT00888550
First received: April 23, 2009
Last updated: September 28, 2010
Last verified: September 2010
History of Changes
  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
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

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888550

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

No publications provided

Responsible Party: Steven Morgan, MD, Denver Health Medical Center
ClinicalTrials.gov Identifier: NCT00888550     History of Changes
Other Study ID Numbers: DHMC07-0216
Study First Received: April 23, 2009
Last Updated: September 28, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013