Clinical trial NCT04063657: External Fixation Versus Splinting of Acute Calcaneus Fractures
Official title: External Fixation Versus Splinting of Acute Calcaneus Fractures Prior to Definitive Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Calcaneus Fracture
Keywords: Staged External Fixation
Splinting
Soft tissue complications
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Time to Definitive Surgery
timeFrame: Within 2 weeks from injury
measure: Soft Tissue Complications
timeFrame: Assessed at 2 weeks after surgery
measure: Soft Tissue Complications
timeFrame: Assessed at 6 weeks after surgery
measure: Soft Tissue Complications
timeFrame: Assessed at 12 weeks after surgery
measure: Soft Tissue Complications
timeFrame: Assessed at 6 months after surgery
measure: Soft Tissue Complications
timeFrame: Assessed at 12 months after surgery
measure: Soft Tissue Complications
timeFrame: Assessed at 24 months after surgery
Secondary outcomes:
measure: Union Rate
timeFrame: Plain xrays at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years after surgery. CT scan at 1 year.
measure: Radiographic Parameters - Bohler's Angle
timeFrame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
measure: Radiographic Parameters - Calcaneal Height
timeFrame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
measure: Radiographic Parameters - Angle of Gissan
timeFrame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
measure: Radiographic Parameters - Calcaneal Width
timeFrame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
measure: Radiographic Parameters - Calcaneal Length
timeFrame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
measure: Functional Outcomes - VAS
timeFrame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery.
measure: Functional Outcomes - FFI-R
timeFrame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
measure: Functional Outcomes - FAAM ADL
timeFrame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
measure: Functional Outcomes - FAAM Sport
timeFrame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
Study officials:
affiliation: Foot and Ankle Surgery Department of Orthopaedic Surgery University of California, Davis Medical Center
name: Christopher D Kreulen, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: