Intramedullary Nailing of Tibia Fractures

Tibial Fractures Clinical Trial

Official title:

Intramedullary Nailing of Tibia Fractures in the Presence of Medial or Posterior Malleolar Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01797640
• Other study ID #: 50553
• Status: Completed
• Phase: N/A
• First received: January 4, 2013
• Last updated: July 8, 2015
• Start date: October 2012
• Est. completion date: April 2015

Study information

• Verified date: July 2015
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

Currently, the treatment of choice for tibial fracture is intramedullary nailing. This procedure has been shown to have low rates of infection, high rates of bone healing, and a faster return to weight bearing and activity in comparison to conservative treatment. In concurrent fractures of the posterior or medial malleolus and the tibia, it is now common to identify, reduce, and fix the malleolar fracture prior to intramedullary nailing of the tibia. In this retrospective study, our aim is to establish that reducing malleolar fractures prior to tibial nailing is a safe treatment in which the reduction of the malleolus is maintained intraoperatively, postoperatively, and remains reduced until the fracture has healed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• All patients, 18+ years of age, that have been treated at the University of Utah over the past five years for tibial fracture combined with medial or posterior malleolar fracture.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone
• Malleolar Fractures
• Tibial Fractures

Locations

Country	Name	City	State
United States	University of Utah Orthopedics Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Malleolar involvement in tibial fracture	Currently the treatment of choice for tibial fracture is intramedullary nailing. This procedure has been shown to have low rates of infection, high rates of bone healing, and a faster return to weight bearing and activity in comparison to conservative treatment.	6 Week Post-Op	No