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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.
Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.
University of California, Davis Medical Center
Sacramento, California, United States
Time to Definitive Surgery
Duration of time from injury to definitive surgery
Time frame: Within 2 weeks from injury
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Time frame: Assessed at 2 weeks after surgery
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Time frame: Assessed at 6 weeks after surgery
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Time frame: Assessed at 12 weeks after surgery
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Time frame: Assessed at 6 months after surgery
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Time frame: Assessed at 12 months after surgery
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Time frame: Assessed at 24 months after surgery
Union Rate
Assessment of fracture healing
Time frame: Plain xrays at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years after surgery. CT scan at 1 year.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Radiographic Parameters - Bohler's Angle
Bohler's angle
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Radiographic Parameters - Calcaneal Height
Calcaneal height
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Radiographic Parameters - Angle of Gissan
Angle of Gissan
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Radiographic Parameters - Calcaneal Width
Calcaneal width
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Radiographic Parameters - Calcaneal Length
Calcaneal length
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Functional Outcomes - VAS
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).
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery.
Functional Outcomes - FFI-R
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.
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Functional Outcomes - FAAM ADL
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.
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Functional Outcomes - FAAM Sport
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.
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery