An interventional study of External fixator and Splinting in Calcaneus Fracture, sponsored by University of California, Davis. Terminated at 1 site in United States. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2022-02-09.
Sponsored by University of California, Davis · Not applicable, Interventional, and Treatment
Aim:
Hypothesis:
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 1 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: External fixator
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.
Procedure: Splinting
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.
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.
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
| Milestone | External Fixation | Splinting |
|---|---|---|
| Started | 1 | 0 |
| Completed | 0 | 0 |
| Not completed | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
Duration of time from injury to definitive surgery
| days | External Fixation | Splinting |
|---|---|---|
| Time to Definitive Surgery | 3 | — |
Incidence of infection, dehiscence and need for soft tissue coverage
No measurements were reported for this outcome.
Incidence of infection, dehiscence and need for soft tissue coverage
No measurements were reported for this outcome.
Incidence of infection, dehiscence and need for soft tissue coverage
No measurements were reported for this outcome.
Incidence of infection, dehiscence and need for soft tissue coverage
No measurements were reported for this outcome.
Incidence of infection, dehiscence and need for soft tissue coverage
No measurements were reported for this outcome.
Incidence of infection, dehiscence and need for soft tissue coverage
No measurements were reported for this outcome.
Assessment of fracture healing
No measurements were reported for this outcome.
Bohler's angle
No measurements were reported for this outcome.
Calcaneal height
No measurements were reported for this outcome.
Angle of Gissan
No measurements were reported for this outcome.
Calcaneal width
No measurements were reported for this outcome.
Calcaneal length
No measurements were reported for this outcome.
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).
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over 24 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| External Fixation | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Splinting | — | — | — |
Study stopped prematurely, only 1 participant enrolled in the external fixation arm.
| Age, Continuous(years) | External Fixation | Splinting | Total |
|---|---|---|---|
| Mean | 50 (50 to 50) | — | 50 (50 to 50) |
| Sex: Female, Male(Participants) | External Fixation | Splinting | Total |
|---|---|---|---|
| Female | 0 | — | 0 |
| Male | 1 | — | 1 |
| Ethnicity (NIH/OMB)(Participants) | External Fixation | Splinting | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | — | 0 |
| Not Hispanic or Latino | 1 | — | 1 |
| Unknown or Not Reported | 0 | — | 0 |
| Race (NIH/OMB)(Participants) | External Fixation | Splinting | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | — | 0 |
| Asian | 0 | — | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | — | 0 |
| Black or African American | 1 | — | 1 |
| White | 0 | — | 0 |
| More than one race | 0 | — | 0 |
| Unknown or Not Reported | 0 | — | 0 |
| Region of Enrollment(participants) | External Fixation | Splinting | Total |
|---|---|---|---|
| United States | 1 | — | 1 |
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University of California, Davis