Trial Outcomes & Findings for External Fixation Versus Splinting of Acute Calcaneus Fractures (NCT NCT04063657)
NCT ID: NCT04063657
Last Updated: 2022-02-09
Results Overview
Incidence of infection, dehiscence and need for soft tissue coverage
TERMINATED
NA
1 participants
Assessed at 12 weeks after surgery
2022-02-09
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
External Fixation Versus Splinting of Acute Calcaneus Fractures
Baseline characteristics by cohort
| Measure |
External Fixation
n=1 Participants
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.
|
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.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
n=99 Participants
|
—
|
50 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
—
|
1 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Within 2 weeks from injuryPopulation: Study stopped prematurely due to poor recruitment. Only 1 subject was enrolled.
Duration of time from injury to definitive surgery
Outcome measures
| Measure |
External Fixation
n=1 Participants
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.
|
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.
|
|---|---|---|
|
Time to Definitive Surgery
|
3 days
|
—
|
PRIMARY outcome
Timeframe: Assessed at 2 weeks after surgeryPopulation: 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.
Incidence of infection, dehiscence and need for soft tissue coverage
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Assessed at 6 weeks after surgeryPopulation: 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.
Incidence of infection, dehiscence and need for soft tissue coverage
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Assessed at 12 weeks after surgeryPopulation: 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.
Incidence of infection, dehiscence and need for soft tissue coverage
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Assessed at 6 months after surgeryPopulation: 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.
Incidence of infection, dehiscence and need for soft tissue coverage
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Assessed at 12 months after surgeryPopulation: 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.
Incidence of infection, dehiscence and need for soft tissue coverage
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Assessed at 24 months after surgeryPopulation: 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.
Incidence of infection, dehiscence and need for soft tissue coverage
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Assessment of fracture healing
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgeryPopulation: 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.
Bohler's angle
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgeryPopulation: 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.
Calcaneal height
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgeryPopulation: 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.
Angle of Gissan
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgeryPopulation: 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.
Calcaneal width
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgeryPopulation: 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.
Calcaneal length
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgeryPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgeryPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgeryPopulation: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
External Fixation
Splinting
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Christopher Kreulen
University of California, Davis
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place