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Study was slow to recruit. PI decided to close study to focus on other trials.
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Aim:
Hypothesis:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| External fixation | Active Comparator | 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. |
|
| Splinting | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External fixator | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Radiographic Parameters - Bohler's Angle | Bohler's angle |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher D Kreulen, MD, MS | Foot and Ankle Surgery Department of Orthopaedic Surgery University of California, Davis Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis Medical Center | Sacramento | California | 95817 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Study stopped prematurely, only 1 participant enrolled in the external fixation arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Definitive Surgery | Duration of time from injury to definitive surgery | Study stopped prematurely due to poor recruitment. Only 1 subject was enrolled. | Posted | Number | days | Within 2 weeks from injury |
|
24 months
Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant was lost to follow-up and did not attend follow up visits.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher Kreulen | University of California, Davis | (916) 734-6805 | ckreulen@ucdavis.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2019 | Jan 12, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 14, 2019 | Jan 12, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016267 | External Fixators |
| D013165 | Splints |
| ID | Term |
|---|---|
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Splinting | Procedure | 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. |
|
| Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery |
| Radiographic Parameters - Calcaneal Height | Calcaneal height | Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery |
| Radiographic Parameters - Angle of Gissan | Angle of Gissan | Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery |
| Radiographic Parameters - Calcaneal Width | Calcaneal width | Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery |
| Radiographic Parameters - Calcaneal Length | Calcaneal length | 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). | 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. | 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. | 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. | Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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. |
|
|
| Primary | Soft Tissue Complications | Incidence of infection, dehiscence and need for soft tissue coverage | 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. | Posted | Assessed at 2 weeks after surgery |
|
|
| Primary | Soft Tissue Complications | Incidence of infection, dehiscence and need for soft tissue coverage | 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. | Posted | Assessed at 6 weeks after surgery |
|
|
| Primary | Soft Tissue Complications | Incidence of infection, dehiscence and need for soft tissue coverage | 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. | Posted | Assessed at 12 weeks after surgery |
|
|
| Primary | Soft Tissue Complications | Incidence of infection, dehiscence and need for soft tissue coverage | 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. | Posted | Assessed at 6 months after surgery |
|
|
| Primary | Soft Tissue Complications | Incidence of infection, dehiscence and need for soft tissue coverage | 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. | Posted | Assessed at 12 months after surgery |
|
|
| Primary | Soft Tissue Complications | Incidence of infection, dehiscence and need for soft tissue coverage | 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. | Posted | Assessed at 24 months after surgery |
|
|
| Secondary | Union Rate | Assessment of fracture healing | 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. | Posted | 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 | 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. | Posted | Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery |
|
|
| Secondary | Radiographic Parameters - Calcaneal Height | Calcaneal height | 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. | Posted | Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery |
|
|
| Secondary | Radiographic Parameters - Angle of Gissan | Angle of Gissan | 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. | Posted | Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery |
|
|
| Secondary | Radiographic Parameters - Calcaneal Width | Calcaneal width | 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. | Posted | Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery |
|
|
| Secondary | Radiographic Parameters - Calcaneal Length | Calcaneal length | 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. | Posted | 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). | 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. | Posted | 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. | 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. | Posted | 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. | 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. | Posted | 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. | 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. | Posted | Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery |
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| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 |
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| D053831 | Surgical Fixation Devices |