Calcaneus Fracture
Conditions
Keywords
Staged External Fixation, Splinting, Soft tissue complications
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
Interventions
PROCEDUREExternal 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.
PROCEDURESplinting
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.
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Definitive Surgery | Within 2 weeks from injury | Duration of time from injury to definitive surgery |
| Soft Tissue Complications | Assessed at 2 weeks after surgery | Incidence of infection, dehiscence and need for soft tissue coverage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Parameters - Calcaneal Height | Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery | Calcaneal height |
| Radiographic Parameters - Angle of Gissan | Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery | Angle of Gissan |
| Radiographic Parameters - Calcaneal Width | Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery | Calcaneal width |
| Radiographic Parameters - Calcaneal Length | Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery | Calcaneal length |
| 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 |
| 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. |
| 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. |
| 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. |
| 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). |
| Radiographic Parameters - Bohler's Angle | Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery | Bohler's angle |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| External Fixation Adults 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.
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. | 1 |
| Splinting Adults 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.
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. | 0 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | External Fixation | Total |
|---|---|---|
| Age, Continuous | 50 years | 50 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants |
| Region of Enrollment United States | 1 participants | 1 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 |
| other Total, other adverse events | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
Primary
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Time frame: Assessed at 2 weeks after surgery
Population: Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.
Primary
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Time frame: Assessed at 6 weeks after surgery
Population: Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.
Primary
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Time frame: Assessed at 12 months after surgery
Population: Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.
Primary
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Time frame: Assessed at 24 months after surgery
Population: Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.
Primary
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Time frame: Assessed at 12 weeks after surgery
Population: Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.
Primary
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Time frame: Assessed at 6 months after surgery
Population: Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.
Primary
Time to Definitive Surgery
Duration of time from injury to definitive surgery
Time frame: Within 2 weeks from injury
Population: Study stopped prematurely due to poor recruitment. Only 1 subject was enrolled.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| External Fixation | Time to Definitive Surgery | 3 days |
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.
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Population: Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.
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.
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Population: Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.
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.
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Population: Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.
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).
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery.
Population: Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.
Secondary
Radiographic Parameters - Angle of Gissan
Angle of Gissan
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Population: Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.
Secondary
Radiographic Parameters - Bohler's Angle
Bohler's angle
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Population: Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.
Secondary
Radiographic Parameters - Calcaneal Height
Calcaneal height
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Population: Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.
Secondary
Radiographic Parameters - Calcaneal Length
Calcaneal length
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Population: Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.
Secondary
Radiographic Parameters - Calcaneal Width
Calcaneal width
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Population: Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.
Secondary
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.
Population: Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.