External Fixation Versus Splinting of Acute Calcaneus Fractures

Calcaneus Fracture Clinical Trial

Official title:

External Fixation Versus Splinting of Acute Calcaneus Fractures Prior to Definitive Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04063657
• Other study ID #: 1436830
• Status: Terminated
• Phase: N/A
• Start date: June 14, 2019
• Est. completion date: September 3, 2019

Study information

• Verified date: January 2022
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 3, 2019
• Est. primary completion date: September 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Calcaneus Fracture
• Fractures, Bone

Intervention

Procedure:
• External fixator
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.
• Splinting
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.

Locations

Country	Name	City	State
United States	University of California, Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Definitive Surgery	Duration of time from injury to definitive surgery	Within 2 weeks from injury
Primary	Soft Tissue Complications	Incidence of infection, dehiscence and need for soft tissue coverage	Assessed at 2 weeks after surgery
Primary	Soft Tissue Complications	Incidence of infection, dehiscence and need for soft tissue coverage	Assessed at 6 weeks after surgery
Primary	Soft Tissue Complications	Incidence of infection, dehiscence and need for soft tissue coverage	Assessed at 12 weeks after surgery
Primary	Soft Tissue Complications	Incidence of infection, dehiscence and need for soft tissue coverage	Assessed at 6 months after surgery
Primary	Soft Tissue Complications	Incidence of infection, dehiscence and need for soft tissue coverage	Assessed at 12 months after surgery
Primary	Soft Tissue Complications	Incidence of infection, dehiscence and need for soft tissue coverage	Assessed at 24 months after surgery
Secondary	Union Rate	Assessment of fracture healing	Plain xrays at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years after surgery. CT scan at 1 year.
Secondary	Radiographic Parameters - Bohler's Angle	Bohler's angle	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Secondary	Radiographic Parameters - Calcaneal Height	Calcaneal height	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Secondary	Radiographic Parameters - Angle of Gissan	Angle of Gissan	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Secondary	Radiographic Parameters - Calcaneal Width	Calcaneal width	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Secondary	Radiographic Parameters - Calcaneal Length	Calcaneal length	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Secondary	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).	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery.
Secondary	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.	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Secondary	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.	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Secondary	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.	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery