Humeral FracturesT-SCHFNCT02640027
The Use of Telemedicine Tool in Supracondylar Humerus Fractures in Children
A study testing Cast removal at home using a telemedicine tool in people with Humeral Fractures, run by University of California, Los Angeles.
Trial summary
Fractures of the supracondylar region of the humerus are among the most common pediatric injuries requiring the attention of an orthopaedic surgeon. Children with non-displaced fractures (Type I), as well as those with history of elbow trauma, have been traditionally managed with non-surgical immobilization. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Humeral Fractures
- What is being tested?
- Cast removal at home using a telemedicine tool
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients between the ages of 2 and 10 years (open physis), who present within seven days of sustaining a closed, non-displaced, type I supracondylar humeral fracture or a closed, acute elbow injury in whom a fracture is not seen but a positive posterior fat pad sign is identified will be considered for inclusion in the present study. In order to be included, the patient's family must have access to an electronic device with a camera (desktop computer, laptop, tablet or cell phone) with internet connectivity, and be willing to download and use a free application for live videoconferencing (WebEx, Cisco Systems). WebEx is a HIPPA compliant videoconferencing system that includes audio and visual components.
Who cannot join
- Patients younger than 2 or older than 10 years of age will be excluded, as well as those with a displaced or open elbow fracture, any associated generalized condition that affects the elbow range of motion, history of a previous injury or surgery to the elbows, a neurovascular abnormalities or suspicion of a compartment syndrome or a pathological fracture.
About this study
Official title: Telemedicine in Supracondylar Humerus Fractures
Fractures of the supracondylar region of the humerus are among the most common pediatric injuries requiring the attention of an orthopaedic surgeon. Children with non-displaced fractures (Type I), as well as those with history of elbow trauma, have been traditionally managed with non-surgical immobilization. Recently published clinical guidelines support such practice, based on the result of two prospective studies in which either collar and cuff or posterior splint immobilization were used. When compared to collar and cuff immobilization, posterior splints resulted in better pain relief within the first two weeks of injury; however, critical outcomes, including the incidence of cubitus varus, hyperextension, and loss of reduction, were not reported.
While posterior splints appear to be an attractive option for the treatment of non-displaced pediatric elbow fractures, a recent retrospective analysis on the use of posterior splints for the treatment of such injuries reported a small proportion of fractures demonstrating displacement. The potential for non-compliance with the use of removable devices, especially in the older pediatric population, is also a concern.
Read more
The use of a removable immobilization that can reliably maintain fracture alignment, minimize the risk of non-compliance, and result in similar outcomes as those obtained with regular casting could be advantageous: It appears that such immobilization could be removed easily and safely at home, potentially resulting in a lower number of patient visits, decreased health-care costs, and higher patient/parent satisfaction.
Telemedicine, defined as the use of telecommunication and information technologies in order to provide clinical health care at a distance, has been seldom used in the field of pediatric orthopaedics. Commonly mentioned attributes of telemedicine include improved access to healthcare providers, cost containment and increased healthcare efficiency, quality care improvements related to patient satisfaction, and potential reduction in travel time for patients and families.
The purpose of this randomized, controlled, prospective study is to assess telemedicine as a tool for the treatment follow-up of non-displaced SCHF fractures in children. Investigators hypothesize that using telemedicine will result in comparable clinical outcomes as those obtained in patients treated in a clinical facility, with increased patient satisfaction and decreased healthcare costs.
Read the detailed description
The investigators will conduct an IRB approved, single-center, randomized, open label trial, in which children who present to the investigators institution with a non-displaced (Type 1) SCHF or an occult elbow injury (as determined by the presence of a posterior fat pad sign) will receive a long-arm soft, fiberglass cast (reinforced with a posterior slab) (3MTD "ScotchcastTM" Soft Cast Casting Tape) with the elbow flexed to 90-100 degrees and with forearm in neutral rotation and will be randomized to one of two groups: Patients in Group A will receive their follow-up care entirely at the investigators institution, while patients in Group B will receive some of the follow-up care using a telemedicine tool. Written informed consent will be obtained from the parents of each patient. For patients between the ages of seven and ten years, child assents will also be obtained.
Randomization will be accomplished by using sealed envelopes, sequentially numbered on the outside, in which a random sequence of A or B will be concealed. Sample size estimation was based on the outcome variable of percent average total satisfaction score. The investigators own previous studies at OIC presented a standard deviation of the satisfaction score of 15%. Clinically significant differences in satisfaction scores were on the order of 10 to 15%. In the present study, 25 patients in each group will be included, for a total of 50 patients. With this sample size, the investigators will be able to detect differences of 12% in satisfaction score with alpha of 0.05 and 80% power.
- Conditions
- Humeral Fractures
- Being tested
- Cast removal at home using a telemedicine tool
- Medical subject headings
- Humeral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cast removal at home using a telemedicine toolProcedure or surgery
Instead of receiving follow up treatment in a clinical setting, patients randomized to the arm of the study requiring telemedicine will receive some of their follow up care at home.
| Study group | Role | What they receive |
|---|---|---|
| Treatment in the Clinic Only | No intervention | Patients in Group A will receive their follow-up care entirely at the investigators institution |
| Treatment in the Clinic and at Home | Experimental | Cast removal at home using a telemedicine tool Receives: Procedure: Cast removal at home using a telemedicine tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture displacement as measured by Baumann Angle
Fracture displacement will be assessed by comparing the initial values of the Baumann angle of the elbow, taken at the 1 week follow up visit, with those obtained during the 8th week follow-up appointment.
Measured: At 8 week follow up visit
Fracture angulation as measured by Shaft Condylar Angle
Fracture angulation will be assessed by comparing the initial values of the shaft-condylar angle of the elbow, taken at the 1 week follow up appointment, and the position of the anterior humeral line with respect to the capitellum, with those obtained during the 8th week follow-up appointment.
Measured: At 8 week follow up visit
Secondary outcomes (2)
Recovery of Range of Motion Using a 6" E-Z Read Jamar® Goniometer
The recovery of ROM will be assessed at the 8th week follow-up by comparing the range of motion of the affected elbow with that of the normal, contralateral elbow. The range of motion of the elbow will be measured with the use of a small goniometer calibrated in 1° increments, using standard techniques. All ROM measurements will be performed by a single observer using the same goniometer.
Measured: 8 Weeks after injury
Elbow Pain Using the Revised Faces Pain Scale
Elbow pain will be measured at weeks 4 and 8 with the use of the Faces Pain Scale. This is a validated, highly reliable scale, commonly used in the pediatric population. Hicks CL, von Baeyer CL, Spafford PA, et al. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001;93:173-183.
Measured: Weeks 4 and 8 after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2015 (estimated)
- Study startMar 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humeral FracturesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauricio Silva, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640027
- Sponsor's protocol ID
- 003
- Acronym
- T-SCHF
- Status last verified
- May 2019
- First submitted
- 16 Dec 2015
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine in Supracondylar Humerus Fractures
- ClinicalTrials.gov ID
- NCT02640027
- Acronym / sponsor ID
- T-SCHF / 003
- Conditions
- Humeral Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 28 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fractures of the supracondylar region of the humerus are among the most common pediatric injuries requiring the attention of an orthopaedic surgeon. Children with non-displaced fractures (Type I), as well as those with history of elbow trauma, have been traditionally managed with non-surgical immobilization. Recently published clinical guidelines support such practice, based on the result of two prospective studies in which either collar and cuff or posterior splint immobilization were used. When compared to collar and cuff immobilization, posterior splints resulted in better pain relief within the first two weeks of injury; however, critical outcomes, including the incidence of cubitus varus, hyperextension, and loss of reduction, were not reported.
While posterior splints appear to be an attractive option for the treatment of non-displaced pediatric elbow fractures, a recent retrospective analysis on the use of posterior splints for the treatment of such injuries reported a small proportion of fractures demonstrating displacement. The potential for non-compliance with the use of removable devices, especially in the older pediatric population, is also a concern.
The use of a removable immobilization that can reliably maintain fracture alignment, minimize the risk of non-compliance, and result in similar outcomes as those obtained with regular casting could be advantageous: It appears that such immobilization could be removed easily and safely at home, potentially resulting in a lower number of patient visits, decreased health-care costs, and higher patient/parent satisfaction.
Telemedicine, defined as the use of telecommunication and information technologies in order to provide clinical health care at a distance, has been seldom used in the field of pediatric orthopaedics. Commonly mentioned attributes of telemedicine include improved access to healthcare providers, cost containment and increased healthcare efficiency, quality care improvements related to patient satisfaction, and potential reduction in travel time for patients and families.
The purpose of this randomized, controlled, prospective study is to assess telemedicine as a tool for the treatment follow-up of non-displaced SCHF fractures in children. Investigators hypothesize that using telemedicine will result in comparable clinical outcomes as those obtained in patients treated in a clinical facility, with increased patient satisfaction and decreased healthcare costs.
Detailed description
The investigators will conduct an IRB approved, single-center, randomized, open label trial, in which children who present to the investigators institution with a non-displaced (Type 1) SCHF or an occult elbow injury (as determined by the presence of a posterior fat pad sign) will receive a long-arm soft, fiberglass cast (reinforced with a posterior slab) (3MTD "ScotchcastTM" Soft Cast Casting Tape) with the elbow flexed to 90-100 degrees and with forearm in neutral rotation and will be randomized to one of two groups: Patients in Group A will receive their follow-up care entirely at the investigators institution, while patients in Group B will receive some of the follow-up care using a telemedicine tool. Written informed consent will be obtained from the parents of each patient. For patients between the ages of seven and ten years, child assents will also be obtained.
Randomization will be accomplished by using sealed envelopes, sequentially numbered on the outside, in which a random sequence of A or B will be concealed. Sample size estimation was based on the outcome variable of percent average total satisfaction score. The investigators own previous studies at OIC presented a standard deviation of the satisfaction score of 15%. Clinically significant differences in satisfaction scores were on the order of 10 to 15%. In the present study, 25 patients in each group will be included, for a total of 50 patients. With this sample size, the investigators will be able to detect differences of 12% in satisfaction score with alpha of 0.05 and 80% power.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment in the Clinic Only | No intervention | –Patients in Group A will receive their follow-up care entirely at the investigators institution |
| Treatment in the Clinic and at Home | Experimental | Procedure: Cast removal at home using a telemedicine toolCast removal at home using a telemedicine tool |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients between the ages of 2 and 10 years (open physis), who present within seven days of sustaining a closed, non-displaced, type I supracondylar humeral fracture or a closed, acute elbow injury in whom a fracture is not seen but a positive posterior fat pad sign is identified will be considered for inclusion in the present study. In order to be included, the patient's family must have access to an electronic device with a camera (desktop computer, laptop, tablet or cell phone) with internet connectivity, and be willing to download and use a free application for live videoconferencing (WebEx, Cisco Systems). WebEx is a HIPPA compliant videoconferencing system that includes audio and visual components.
Key exclusion criteria (1 listed)
- Patients younger than 2 or older than 10 years of age will be excluded, as well as those with a displaced or open elbow fracture, any associated generalized condition that affects the elbow range of motion, history of a previous injury or surgery to the elbows, a neurovascular abnormalities or suspicion of a compartment syndrome or a pathological fracture.
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 |
|---|---|---|
| Cast removal at home using a telemedicine toolInstead of receiving follow up treatment in a clinical setting, patients randomized to the arm of the study requiring telemedicine will receive some of their follow up care at home. | Procedure or surgery | Treatment in the Clinic and at Home |
Primary outcome
Fracture displacement as measured by Baumann Angle
Time frame: At 8 week follow up visit
Fracture displacement will be assessed by comparing the initial values of the Baumann angle of the elbow, taken at the 1 week follow up visit, with those obtained during the 8th week follow-up appointment.
Fracture angulation as measured by Shaft Condylar Angle
Time frame: At 8 week follow up visit
Fracture angulation will be assessed by comparing the initial values of the shaft-condylar angle of the elbow, taken at the 1 week follow up appointment, and the position of the anterior humeral line with respect to the capitellum, with those obtained during the 8th week follow-up appointment.
2 secondary outcomes
Recovery of Range of Motion Using a 6" E-Z Read Jamar® Goniometer
Time frame: 8 Weeks after injury
Elbow Pain Using the Revised Faces Pain Scale
Time frame: Weeks 4 and 8 after injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cast removal at home using a telemedicine tool in people with Humeral Fractures, run by University of California, Los Angeles.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fracture displacement as measured by Baumann Angle (time frame: At 8 week follow up visit). The study lists 2 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 16 May 2019.