Calcaneus FractureNCT04063657
External Fixation Versus Splinting of Acute Calcaneus Fractures
A study testing External fixator and Splinting in people with Calcaneus Fracture, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Calcaneus Fracture
- What is being tested?
- External fixator and Splinting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2019to 3 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age <18
- Prior surgery of the affected extremity
- Prisoners
- Pregnant women
- Inflammatory arthritis
- Non-English-speaking patients
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis Medical Center
Sacramento, California, 95817
About this study
Official title: External Fixation Versus Splinting of Acute Calcaneus Fractures Prior to Definitive Surgery
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
- Conditions
- Calcaneus Fracture
- Being tested
- External fixator, Splinting
- Keywords
- Staged External Fixation, Splinting, Soft tissue complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External fixatorProcedure or surgery
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.
SplintingProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: External fixator |
| 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. Receives: Procedure: Splinting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Definitive Surgery
Duration of time from injury to definitive surgery
Measured: Within 2 weeks from injury
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Measured: Assessed at 2 weeks after surgery
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Measured: Assessed at 6 weeks after surgery
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Measured: Assessed at 12 weeks after surgery
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Measured: Assessed at 6 months after surgery
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Measured: Assessed at 12 months after surgery
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Measured: Assessed at 24 months after surgery
Secondary outcomes (10)
Union Rate
Assessment of fracture healing
Measured: 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
Measured: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Radiographic Parameters - Calcaneal Height
Calcaneal height
Measured: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Radiographic Parameters - Angle of Gissan
Angle of Gissan
Measured: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Radiographic Parameters - Calcaneal Width
Calcaneal width
Measured: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Radiographic Parameters - Calcaneal Length
Calcaneal length
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start14 Jun 2019
- Primary completion3 Sep 2019
- Study completion3 Sep 2019
Why it stopped: Study was slow to recruit. PI decided to close study to focus on other trials.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Calcaneus FractureStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher D Kreulen, MD, MS, Principal investigator, Foot and Ankle Surgery Department of Orthopaedic Surgery University of California, Davis Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063657
- Sponsor's protocol ID
- 1436830
- Status last verified
- Jan 2022
- First submitted
- 7 Aug 2019
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Fixation Versus Splinting of Acute Calcaneus Fractures Prior to Definitive Surgery
- ClinicalTrials.gov ID
- NCT04063657
- Acronym / sponsor ID
- 1436830
- Conditions
- Calcaneus Fracture
- Keywords
- Staged External Fixation, Splinting, Soft tissue complications
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was slow to recruit. PI decided to close study to focus on other trials.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- 3 Sep 2019 (actual)
- Study completion
- 3 Sep 2019 (actual)
- First posted
- 21 Aug 2019 (actual)
- Results
- Posted 9 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External fixation | Active comparator | Procedure: External fixatorAdults 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 | Procedure: SplintingAdults 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. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Age <18
- Prior surgery of the affected extremity
- Prisoners
- Pregnant women
- Inflammatory arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External fixatorPatients 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. | Procedure or surgery | External fixation |
| SplintingPatients 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. | Procedure or surgery | Splinting |
Primary outcome
Time to Definitive Surgery
Time frame: Within 2 weeks from injury
Duration of time from injury to definitive surgery
Soft Tissue Complications
Time frame: Assessed at 2 weeks after surgery
Incidence of infection, dehiscence and need for soft tissue coverage
Soft Tissue Complications
Time frame: Assessed at 6 weeks after surgery
Incidence of infection, dehiscence and need for soft tissue coverage
Soft Tissue Complications
Time frame: Assessed at 12 weeks after surgery
Incidence of infection, dehiscence and need for soft tissue coverage
Soft Tissue Complications
Time frame: Assessed at 6 months after surgery
Incidence of infection, dehiscence and need for soft tissue coverage
Soft Tissue Complications
Time frame: Assessed at 12 months after surgery
Incidence of infection, dehiscence and need for soft tissue coverage
Soft Tissue Complications
Time frame: Assessed at 24 months after surgery
Incidence of infection, dehiscence and need for soft tissue coverage
10 secondary outcomes
Union Rate
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
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Radiographic Parameters - Calcaneal Height
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Radiographic Parameters - Angle of Gissan
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Radiographic Parameters - Calcaneal Width
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Radiographic Parameters - Calcaneal Length
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Functional Outcomes - VAS
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery.
Functional Outcomes - FFI-R
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Functional Outcomes - FAAM ADL
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Functional Outcomes - FAAM Sport
Time frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher D Kreulen, MD, MS principal investigator
Foot and Ankle Surgery Department of Orthopaedic Surgery University of California, Davis Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External fixator and Splinting in people with Calcaneus Fracture, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Definitive Surgery (time frame: Within 2 weeks from injury). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.