Fracture of Radius and UlnaNCT05470257
Randomized Control Trial: Elbow Extension Versus Flexion Cast in Proximal Half Both Bone Forearm Fractures
A study testing Cast in people with Fracture of Radius and Ulna, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to compare outcomes between two immobilization methods for pediatric proximal half both bone forearm fractures. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Fracture of Radius and Ulna
- What is being tested?
- Cast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2023to 12 Feb 2026
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 3-18
- Skeletally immature
- Unilateral Radius and Ulna Fracture located within the proximal ½ of each bone
- Fracture requires reduction and casting
Who cannot join
- Ages < 3
- Distal ½ Radius and Ulna Forearm Fracture
- Isolated radius or ulna fracture
- Humerus Fracture of the Ipsilateral Arm (including floating elbow)
- Metabolic Bone Disease
- Open Fractures
Show all 9Show fewer
- Monteggia and Galeazzi Fractures
- Deformity or abnormality not allowing for standard casting (limb deficiency, contracture)
- Parent speaks language other than english
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare outcomes between two immobilization methods for pediatric proximal half both bone forearm fractures.
Read the detailed description
After being informed of the study including potential risks and benefits, all patients giving assent and guardian/parents consent who meet eligibility will undergo randomization of the casting technique used (elbow extension or elbow flexion casting). Randomization will occur using a random umber generator. Even numbers generated will result in an extension cast and odd numbers generated will result in a flexion cast.
The patients will be followed in clinic with an examination and x-rays at 2, 3, 5, and 8 weeks after casting to evaluate alignment of the fracture maintained by each cast. The two cohorts will be compared at the end of the study to determine which casting technique is the superior immobilization for pediatric proximal half both bone forearm fractures.
- Conditions
- Fracture of Radius and Ulna
- Being tested
- Cast
- Keywords
- both bone forearm fracture, cast, pediatric
- Medical subject headings
- Radius Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CastOther
Application of fiberglass long arm cast.
| Study group | Role | What they receive |
|---|---|---|
| Elbow Flexion Cast | Experimental | This cohort will be placed in a long arm flexion cast. Receives: Other: Cast |
| Elbow Extension Cast | Experimental | This cohort will be placed in a long arm extension cast. Receives: Other: Cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alignment/Loss of Reduction
During clinic visits, xrays will be obtained to measure alignment of the radius and ulna fracture and asses for loss of reduction or malalignment. We will compare the number of patients with proximal both bone forearm fractures that have lost alignment after 8 weeks between the flexion elbow cast cohort compared to the extension elbow cast cohort.
Measured: This will be accessed in clinic via x-rays until 8 weeks status post cast application.
Secondary outcomes (1)
Cast Complications
We will compare the casting complications between elbow extension versus elbow flexion casting cohorts. Casting complications we will observe will be cast saw burns, cast slipping, and need for bivalve of casts.
Measured: Casting complications will be followed the full duration of the patient wearing a cast, which is expected to be around 6-8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start7 Apr 2023
- Primary completion12 Feb 2026
- Study completion12 Feb 2026
Why it stopped: Not able to enroll enough patients for analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of Radius and UlnaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Model description
- Two cohorts will be established. One will include patients casted in elbow extension. The other cohort will include patients casted in elbow flexion.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Philip Ashley, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470257
- Sponsor's protocol ID
- BBFARCT
- Other IDs
- T35HL007473
- Status last verified
- Feb 2026
- First submitted
- 20 Jul 2022
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial: Elbow Extension Versus Flexion Cast in Proximal Half Both Bone Forearm Fractures
- ClinicalTrials.gov ID
- NCT05470257
- Acronym / sponsor ID
- BBFARCT
- Conditions
- Fracture of Radius and Ulna
- Keywords
- both bone forearm fracture, cast, pediatric
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not able to enroll enough patients for analysis
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 7 Apr 2023 (actual)
- Primary completion
- 12 Feb 2026 (actual)
- Study completion
- 12 Feb 2026 (actual)
- First posted
- 22 Jul 2022 (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 purpose of this study is to compare outcomes between two immobilization methods for pediatric proximal half both bone forearm fractures.
Detailed description
After being informed of the study including potential risks and benefits, all patients giving assent and guardian/parents consent who meet eligibility will undergo randomization of the casting technique used (elbow extension or elbow flexion casting). Randomization will occur using a random umber generator. Even numbers generated will result in an extension cast and odd numbers generated will result in a flexion cast.
The patients will be followed in clinic with an examination and x-rays at 2, 3, 5, and 8 weeks after casting to evaluate alignment of the fracture maintained by each cast. The two cohorts will be compared at the end of the study to determine which casting technique is the superior immobilization for pediatric proximal half both bone forearm fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two cohorts will be established. One will include patients casted in elbow extension. The other cohort will include patients casted in elbow flexion.
| Arm | Type | Receives |
|---|---|---|
| Elbow Flexion Cast | Experimental | Other: CastThis cohort will be placed in a long arm flexion cast. |
| Elbow Extension Cast | Experimental | Other: CastThis cohort will be placed in a long arm extension cast. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Ages 3-18
- Skeletally immature
- Unilateral Radius and Ulna Fracture located within the proximal ½ of each bone
- Fracture requires reduction and casting
Key exclusion criteria (9 listed)
- Ages < 3
- Distal ½ Radius and Ulna Forearm Fracture
- Isolated radius or ulna fracture
- Humerus Fracture of the Ipsilateral Arm (including floating elbow)
- Metabolic Bone Disease
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 |
|---|---|---|
| CastApplication of fiberglass long arm cast. | Other | Elbow Extension Cast, Elbow Flexion Cast |
Primary outcome
Alignment/Loss of Reduction
Time frame: This will be accessed in clinic via x-rays until 8 weeks status post cast application.
During clinic visits, xrays will be obtained to measure alignment of the radius and ulna fracture and asses for loss of reduction or malalignment. We will compare the number of patients with proximal both bone forearm fractures that have lost alignment after 8 weeks between the flexion elbow cast cohort compared to the extension elbow cast cohort.
1 secondary outcome
Cast Complications
Time frame: Casting complications will be followed the full duration of the patient wearing a cast, which is expected to be around 6-8 weeks.
Results and safety
The study was stopped early (reason given: Not able to enroll enough patients for analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- 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.
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 of Radius and Ulna, run by University of Alabama at Birmingham 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 9 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 17 Feb 2026. 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 stopped early (reason given: Not able to enroll enough patients for analysis). Results are not available in the source record.
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/Loss of Reduction (time frame: This will be accessed in clinic via x-rays until 8 weeks status post cast application.). 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 17 Feb 2026.