Study Stopped
Study was slow to recruit. PI decided to close study to focus on other trials.
External Fixation Versus Splinting of Acute Calcaneus Fractures
1 other identifier
interventional
1
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 14, 2019
CompletedFirst Submitted
Initial submission to the registry
August 7, 2019
CompletedFirst Posted
Study publicly available on registry
August 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 3, 2019
CompletedResults Posted
Study results publicly available
February 9, 2022
CompletedFebruary 9, 2022
January 1, 2022
3 months
August 7, 2019
January 12, 2022
January 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Time to Definitive Surgery
Duration of time from injury to definitive surgery
Within 2 weeks from injury
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Assessed at 2 weeks after surgery
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Assessed at 6 weeks after surgery
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Assessed at 12 weeks after surgery
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Assessed at 6 months after surgery
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Assessed at 12 months after surgery
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Assessed at 24 months after surgery
Secondary Outcomes (10)
Union Rate
Plain xrays at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years after surgery. CT scan at 1 year.
Radiographic Parameters - Bohler's Angle
Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Radiographic Parameters - Calcaneal Height
Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Radiographic Parameters - Angle of Gissan
Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Radiographic Parameters - Calcaneal Width
Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
- +5 more secondary outcomes
Study Arms (2)
External fixation
ACTIVE COMPARATORAdults diagnosed with an acute (\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.
Splinting
ACTIVE COMPARATORAdults diagnosed with an acute (\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Age \<18
- Prior surgery of the affected extremity
- Prisoners
- Pregnant women
- Inflammatory arthritis
- Non-English-speaking patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, Davis Medical Center
Sacramento, California, 95817, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled.
Results Point of Contact
- Title
- Dr. Christopher Kreulen
- Organization
- University of California, Davis
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher D Kreulen, MD, MS
Foot and Ankle Surgery Department of Orthopaedic Surgery University of California, Davis Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2019
First Posted
August 21, 2019
Study Start
June 14, 2019
Primary Completion
September 3, 2019
Study Completion
September 3, 2019
Last Updated
February 9, 2022
Results First Posted
February 9, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share