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CompletedNCT01797640Updated Jul 9, 2015

Intramedullary Nailing of Tibia Fractures

An observational study in Tibial Fractures and Malleolar Fractures, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-09.

Sponsored by University of Utah · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
90
Ages
18 Years to 95 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Tibial Fractures
  • Malleolar Fractures

Keywords

  • Tibia Fractures
  • Medial Fractures
  • Posterior Malleolar Fractures
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's enrollment of 90 is close to the median of 100 across 675 observational studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.

Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Prospectively evaluating all patients that have been treated at the University of Utah over the past five years for Tibial Fracture combined with medial or posterior malleloar fracture.

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

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
90 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 Week Post-Op

07

Study locations

1 site
  • University of Utah Orthopedics Center
    Salt Lake City, Utah 84121, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01797640
Lead sponsor
University of Utah
Responsible party
Eric Kubiak (M.D., University of Utah) — Principal investigator
First posted
Feb 22, 2013
Start date
Oct 2012
Primary completion
Apr 2015
Completion
Apr 2015
Last update
Jul 9, 2015

Study contacts

Erik Kubiak
principal investigator · Orthopedic Surgery Operations

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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