Clinical Trial: Sinus Tarsi Versus Extensile Lateral Approach for Calcaneus Fractures

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Sinus Tarsi Versus Extensile Lateral Approach for Open Reduction Internal Fixation of Intra-articular Calcaneus Fractures

Brief Summary:

This study is a prospective, randomized controlled trial comparing the sinus tarsi approach to the extensile lateral approach for surgical fixation of calcaneus fractures.

It is hypothesized that open reduction and internal fixation of intra-articular calcaneus fractures using a sinus tarsi approach will provide equivalent fracture reduction and stable fixation with significantly decreased wound complication rates in comparison to an extensile lateral approach.


Detailed Summary:
Sponsor: University of Tennessee

Current Primary Outcome: Wound complication rate [ Time Frame: approximately one year ]

There is an expected wound complication rate of up to 30% with this type of fracture. The difference in wound complication rate between the two surgical approaches will be the primary outcome measure. Wound complications will be defined by the presence of superficial or deep infections, skin edge necrosis, and soft tissue sloughing.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Fracture healing [ Time Frame: approximately one year ]
    On radiographic and clinical exam
  • Rate of sural nerve injury [ Time Frame: approximately one year ]
  • Rate of peroneal tendon injury [ Time Frame: approximately one year ]
  • Change in operative time [ Time Frame: one day ]
  • Rate of secondary surgery [ Time Frame: approximately one year ]
  • Visual Analog Scale [ Time Frame: approximately one year ]
    Pain Score
  • American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale [ Time Frame: approximately one year ]
    Functional Outcome Score
  • Foot Function Index [ Time Frame: approximately one year ]
    Functional Outcome Score
  • Short-Form 36 (SF-36) Health Survey [ Time Frame: approximately one year ]
    Functional Outcome Score


Original Secondary Outcome: Same as current

Information By: University of Tennessee

Dates:
Date Received: April 30, 2015
Date Started: May 2015
Date Completion: May 2022
Last Updated: May 13, 2015
Last Verified: May 2015