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 ]
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