Fracture;ElbowNCT03935516
Extended vs Flexed Elbow Casting
A study testing Cast in people with Fracture;Elbow, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The study design is a prospective, randomized controlled trial comparing extended elbow and flexed elbow casting. This study design will provide the highest quality evidence to investigate our primary hypothesis that extended elbow casting for proximal both bone forearm fractures will result in less loss of fracture… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Fracture;Elbow
- What is being tested?
- Cast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2017to 15 Oct 2019
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Both bone forearm fractures in which the fracture of the radius and/or ulna is located in the proximal one half of the bone
- The fracture requires a reduction maneuver
- All skeletally immature individuals under the age of 18
- Patient aged greater than three years old
- Patient or patient's consenting parent/guardian competent in English.
Who cannot join
- Skeletally mature individuals
- Both fractures are located in the distal one-half of the radius and ulna
- Isolated fractures of the radius or ulna
- The fracture does not require a reduction maneuver
- Any nerve or arterial injury in the injured extremity
- Humerus fracture on the ipsilateral side
Show all 10Show fewer
- Any open fracture requiring formal surgical debridement
- Patient or patient's consenting parent/guardian not competent in English.
- Patient or patient's consenting parent/guardian not present.
- 9. Severe problems with maintaining follow-up (e.g live in different state) 10. Contractures in which applying an extended elbow cast is not possible or practical
Trial locations and contacts
1 site in 1 country.
United States1 site
American Family Children's Hospital
Madison, Wisconsin, 53705
About this study
Official title: Comparing Outcomes of Extended Elbow Versus Flexed Elbow Casting for Treatment of Displaced Pediatric Both Bone Forearm Fractures: A Randomized, Controlled Trial
The study design is a prospective, randomized controlled trial comparing extended elbow and flexed elbow casting. This study design will provide the highest quality evidence to investigate our primary hypothesis that extended elbow casting for proximal both bone forearm fractures will result in less loss of fracture alignment. The study population eligible for screening will be patients with open growth plates and both bone forearm fractures.
Read the detailed description
Guardians of patients will be approached for informed consent as soon as is feasible following determination of eligibility. Injury characteristics will be obtained from the enrolling physician and the participant's medical record.
Participants will be prospectively followed at 2, 4, 6, and 24 weeks post casting. All follow-ups will occur in person in clinic and will consist of radiographs, a clinical examination and a brief interview. The follow up time points and radiographs are all part of standard clinical care. The 24 week follow up visit is an optional clinical care visit.
Study duration: 48 months; 40 month enrollment period, 6 month patient follow up and 2 month data analysis period
Sample size: 88 patients will be consented per arm.
Questionnaires: All questionnaires will take approximately 10 minutes total of the family's time. And all questionnaires for done solely for research purposes.
Treatment Crossover Cross over from one treatment arm to another should be rare. Cross over should only occur because of poor cast tolerance or inability to maintain reduction in one position vs. another. If the extension cast is unsatisfactory to the caregivers/guardians or patients they may be converted to a flexed elbow cast. These study participants will remain in the study and be included in an intention-to-treat manner in the final analysis.
To streamline the ease of randomization in a busy department like the ED, patients with an even medical record number will be enrolled in the extended elbow cast and all odd medical record number patients will be enrolled in the flexed elbow cast. All CRFs will be pre-labeled with a study ID. The research staff will then record the study ID on the paper log that is locked in the ED cabinet. The consents/assents and the eligibility checklist will be stored in a separate folder in the ED cabinet and picked up weekly by the study coordinator who will then store the consents/assents and eligibility checklist of enrolled patients in a locked filing cabinet in their Dept. of Ortho office.
All study visits coincide with regular clinic follow up. The 5 month visits is an optional clinic visit. The Demographic questionnaire (CRF 001) will be given to them at the first clinic visit. The family will be asked verbally for responses to CRF 003 regarding cast and patient experience at every clinic visit. The rest of the CRFs will be completed by study staff regarding condition of cast (CRF003), CRF002 deals with the alignment of both forearm bones via the radiograph, and CRF004 is the elbow motion evaluation done by the study staff. CRF004 is a formal measurement using a goniometer (protractor), whereas the clinical standard of care is visual assessment without the goniometer.
- Conditions
- Fracture;Elbow
- Being tested
- Cast
- Keywords
- cast, open growth plate, pediatric, both bone
- Medical subject headings
- Elbow Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CastOther
The use of plaster and/or fiberglass for casting of subject arm.
| Study group | Role | What they receive |
|---|---|---|
| Flexed Elbow | Experimental | The first group will be placed in a cast with the elbow bent. Receives: Other: Cast |
| Extended Elbow | Experimental | The second will be placed in a cast with the elbow straight. Receives: Other: Cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alignment
To compare the proportion of proximal both bone forearm fractures that have lost alignment within 6 weeks in patients treated in a flexed elbow cast compared to those treated in an extended elbow cast.
Measured: 6 weeks
Secondary outcomes (3)
Complication Rate
To compare cast complication rate between those treated in cast with elbow in flexion compared to those treated with elbow in extension.
Measured: approximately 24 weeks
Range of Motion
To compare elbow range of motion at 6 weeks and 24 weeks post-treatment between patients treated in cast with elbow in flexion compared to those treated with elbow in extension
Measured: 6 weeks and 24 weeks
Caregiver Satisfaction Scores
Overall condition and satisfaction of patient's cast.
Measured by: excellent, good, average, below average, or poor.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start19 Dec 2017
- Primary completion15 Oct 2019
- Study completion15 Oct 2019
Why it stopped: Study team had difficulties recruiting and enrolling patients into this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture;ElbowStudies of the same condition, open and under way.
- 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
- Model description
- The study design is a prospective, randomized controlled trial comparing extended elbow and flexed elbow casting.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935516
- Sponsor's protocol ID
- 2017-1056
- Other IDs
- SMPH\ORTHOPEDIC&REHAB\ORTHO, A536110
- Status last verified
- Apr 2020
- First submitted
- 29 May 2018
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Outcomes of Extended Elbow Versus Flexed Elbow Casting for Treatment of Displaced Pediatric Both Bone Forearm Fractures: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03935516
- Acronym / sponsor ID
- 2017-1056
- Conditions
- Fracture;Elbow
- Keywords
- cast, open growth plate, pediatric, both bone
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study team had difficulties recruiting and enrolling patients into this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 19 Dec 2017 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 2 May 2019 (actual)
- 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.
The study design is a prospective, randomized controlled trial comparing extended elbow and flexed elbow casting. This study design will provide the highest quality evidence to investigate our primary hypothesis that extended elbow casting for proximal both bone forearm fractures will result in less loss of fracture alignment. The study population eligible for screening will be patients with open growth plates and both bone forearm fractures.
Detailed description
Guardians of patients will be approached for informed consent as soon as is feasible following determination of eligibility. Injury characteristics will be obtained from the enrolling physician and the participant's medical record.
Participants will be prospectively followed at 2, 4, 6, and 24 weeks post casting. All follow-ups will occur in person in clinic and will consist of radiographs, a clinical examination and a brief interview. The follow up time points and radiographs are all part of standard clinical care. The 24 week follow up visit is an optional clinical care visit.
Study duration: 48 months; 40 month enrollment period, 6 month patient follow up and 2 month data analysis period
Sample size: 88 patients will be consented per arm.
Questionnaires: All questionnaires will take approximately 10 minutes total of the family's time. And all questionnaires for done solely for research purposes.
Treatment Crossover Cross over from one treatment arm to another should be rare. Cross over should only occur because of poor cast tolerance or inability to maintain reduction in one position vs. another. If the extension cast is unsatisfactory to the caregivers/guardians or patients they may be converted to a flexed elbow cast. These study participants will remain in the study and be included in an intention-to-treat manner in the final analysis.
To streamline the ease of randomization in a busy department like the ED, patients with an even medical record number will be enrolled in the extended elbow cast and all odd medical record number patients will be enrolled in the flexed elbow cast. All CRFs will be pre-labeled with a study ID. The research staff will then record the study ID on the paper log that is locked in the ED cabinet. The consents/assents and the eligibility checklist will be stored in a separate folder in the ED cabinet and picked up weekly by the study coordinator who will then store the consents/assents and eligibility checklist of enrolled patients in a locked filing cabinet in their Dept. of Ortho office.
All study visits coincide with regular clinic follow up. The 5 month visits is an optional clinic visit. The Demographic questionnaire (CRF 001) will be given to them at the first clinic visit. The family will be asked verbally for responses to CRF 003 regarding cast and patient experience at every clinic visit. The rest of the CRFs will be completed by study staff regarding condition of cast (CRF003), CRF002 deals with the alignment of both forearm bones via the radiograph, and CRF004 is the elbow motion evaluation done by the study staff. CRF004 is a formal measurement using a goniometer (protractor), whereas the clinical standard of care is visual assessment without the goniometer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study design is a prospective, randomized controlled trial comparing extended elbow and flexed elbow casting.
| Arm | Type | Receives |
|---|---|---|
| Flexed Elbow | Experimental | Other: CastThe first group will be placed in a cast with the elbow bent. |
| Extended Elbow | Experimental | Other: CastThe second will be placed in a cast with the elbow straight. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Both bone forearm fractures in which the fracture of the radius and/or ulna is located in the proximal one half of the bone
- The fracture requires a reduction maneuver
- All skeletally immature individuals under the age of 18
- Patient aged greater than three years old
- Patient or patient's consenting parent/guardian competent in English.
Key exclusion criteria (10 listed)
- Skeletally mature individuals
- Both fractures are located in the distal one-half of the radius and ulna
- Isolated fractures of the radius or ulna
- The fracture does not require a reduction maneuver
- Any nerve or arterial injury in the injured extremity
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 |
|---|---|---|
| CastThe use of plaster and/or fiberglass for casting of subject arm. | Other | Extended Elbow, Flexed Elbow |
Primary outcome
Alignment
Time frame: 6 weeks
To compare the proportion of proximal both bone forearm fractures that have lost alignment within 6 weeks in patients treated in a flexed elbow cast compared to those treated in an extended elbow cast.
3 secondary outcomes
Complication Rate
Time frame: approximately 24 weeks
Range of Motion
Time frame: 6 weeks and 24 weeks
Caregiver Satisfaction Scores
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cast in people with Fracture;Elbow, run by University of Wisconsin, Madison 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 5 inclusion and 10 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: withdrawn, as of the sponsor's last update on 7 Apr 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Alignment (time frame: 6 weeks). 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 7 Apr 2020.