External Fixation Versus Splinting of Acute Calcaneus Fractures

Not Applicable

Terminated

Conditions: Calcaneus Fracture

Registration Number: NCT04063657

Lead Sponsor: University of California, Davis

Brief Summary: Aim:

* Determine if external fixation decreases soft tissue complications compared to splinting.

* Determine if external fixation decreases time to definitive surgical stabilization and improves final fixation compared to splinting.

* Determine if external fixation improves functional outcomes as evaluated by validated functional scoring systems.

Hypothesis:

* External fixation improves definitive fixation and functional outcomes of acute calcaneal fractures with decreased complication rates compared to splinting

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 1

Inclusion Criteria

Voluntary consent
Age 18 to 69
Clinical and/or advanced imaging confirming an acute calcaneal fracture that has occurred within 2 days of which, eventually definitive surgery is recommended/accepted.
Unable to consent

Exclusion Criteria

Age <18
Prior surgery of the affected extremity
Prisoners
Pregnant women
Inflammatory arthritis
Non-English-speaking patients

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to Definitive Surgery	Within 2 weeks from injury	Duration of time from injury to definitive surgery
Soft Tissue Complications	Assessed at 24 months after surgery	Incidence of infection, dehiscence and need for soft tissue coverage

Secondary Outcome Measures

Name	Time	Method
Radiographic Parameters - Calcaneal Width	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery	Calcaneal width
Functional Outcomes - FAAM ADL	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery	Foot and Ankle Ability measure activities of daily living (FAAM ADL) is a 21-item activities assessing the patient's functionality related to their activities of daily living. The response to each item is scored from 4 to 0, with 4 being ''no difficulty'' and 0 being ''unable to do." Scale 0-84. Higher scores indicate a more favorable functional level.
Union Rate	Plain xrays at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years after surgery. CT scan at 1 year.	Assessment of fracture healing
Radiographic Parameters - Calcaneal Height	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery	Calcaneal height
Functional Outcomes - VAS	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery.	Assess Visual Analogue pain score(VAS). This will be a patient reported measure from 0-10, minimum score of 0 (no pain), maximum score of 10 (most pain).
Functional Outcomes - FAAM Sport	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery	Foot and Ankle Ability measure activities of daily living (FAAM Sport) is a 8-item questionnaire assess the patient's ability to participate in athletic activities. The response to each item is scored from 4 to 0, with 4 being ''no difficulty'' and 0 being ''unable to do." Scale 0-32. Higher scores indicate a more favorable functional level.
Radiographic Parameters - Angle of Gissan	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery	Angle of Gissan
Radiographic Parameters - Calcaneal Length	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery	Calcaneal length
Functional Outcomes - FFI-R	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery	Revised foot function index questionnaire (FFI-R) will assess patient pain, stiffness, activity, difficulties with ambulation, and social issues. The score is tabulated from 34 questions answered 1-5 (1= none of the time, 5= All of the time, scale 34-170). Higher scores indicate worse outcomes.
Radiographic Parameters - Bohler's Angle	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery	Bohler's angle

Trial Locations

Locations (1): University of California, Davis Medical Center
🇺🇸
Sacramento, California, United States
University of California, Davis Medical Center
🇺🇸Sacramento, California, United States