Distal Radius FractureNCT05716438
Prospective Evaluation of Cast Bivalving for Pediatric Distal Radius Fractures
An observational study of Distal Radius Fracture and Loss of Anatomical Alignment After Fracture Reduction, run by Brooke Army Medical Center at 1 site in United States.
Trial summary
Pediatric patients with distal radius fractures are most commonly treated non-operatively with fracture reduction and cast immobilization. In order to prevent complications from increased swelling after the injury (or fracture manipulation) casts may be split along their length to relieve pressure. Read more about this study
- Who is it for?
- Ages 1 year to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fracture, Loss of Anatomical Alignment After Fracture Reduction
- What is being tested?
- Forearm anteroposterior and lateral plain radiograph
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 15 Jul 2023
- Phase
- Observational
- 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 1 year to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pediatric patients with displaced distal radius fractures requiring reduction presenting to Brooke Army Medical Center within 72 hours of injury.
Who may be able to join
- Guardian must be present
- Able/eligible to complete follow-up
- Initial injury within 72 hours
- Distal Radius fracture with or without distal ulna fracture
- Requiring non-operative management with molded cast
Who cannot join
- Open fractures
- Re-fractures
- Pathologic fractures
- Fractures associated with neurovascular injury
- Poly trauma incident
- Intubated patients or unable to verbalize symptoms of pain
- Preexisting medical history that effects musculoskeletal health
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
About this study
Official title: Prospective Evaluation of Loss of Reduction and Cast Parameters Following Cast Bivalving for Pediatric Distal Radius Fractures
Pediatric patients with distal radius fractures are most commonly treated non-operatively with fracture reduction and cast immobilization. In order to prevent complications from increased swelling after the injury (or fracture manipulation) casts may be split along their length to relieve pressure. However, this can compromise the casts' structural integrity, predisposing fractures to loss of reduction. The goal of this study was to investigate if cast bivalving, or splitting the cast longitudinally on both sides, resulted in any immediate change to bony alignment and to assess if bivalving effected cast parameters associated with loss of reduction.
Read the detailed description
Displaced pediatric distal radius fractures are treated with fracture reduction and cast immobilization. Currently, at our institution (and many others) radiographic assessment to determine acceptable fracture alignment and cast parameters is done immediately after cast application. However, afterward casts are often split on both sides along their length, in a process known as bivalving, prophylactically treating for post-traumatic soft tissue edema. While bivalving is felt to relieve pressure from the cast, it may also diminish the structural integrity of the cast. Although it is well-established that loss of fracture alignment is most common in the first few weeks after fracture reduction there have been no studies to evaluate any immediate changes to fracture reduction or cast parameters that may occur after bivalving. Thus, the goal of this study was to assess if pediatric distal radius fracture alignment was affected by cast bivalving by obtaining post-bivalve radiographs in addition to standard post-cast radiographs.
- Being tested
- Forearm anteroposterior and lateral plain radiograph
- Keywords
- Cast, Pediatric, Cast Index, Distal Radius Fracture, Loss of Reduction, Bivalve
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forearm anteroposterior and lateral plain radiographRadiation
2 view plain film of forearm after valving a short arm cast.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in reduction after bivalving
Change in fracture reduction of 2mm or 5 degrees in angulation on radiographs after bivalving
Measured: up to 24 hours
Change in reduction at follow-up
Change in fracture reduction of 2mm or 5 degrees in angulation on radiographs at follow-up
Measured: up to 30 days
Cast Index
Cast index, the ratio of sagittal to coronal width from the inside edges of the cast at the fracture site will be measured via radiographs.
Measured: through study completion, up to 2 years
Gap Index
Gap index is a measure of space between the cast and skin measured as a ratio to the inside diameter of the cast, assessed at the level of the fracture on anteroposterior and lateral radiographs.
Measured: through study completion, up to 2 years
Three Point Index
Three point index, a measure of space between the cast and skin at sites of the three point mold, with reference to the adequacy of reduction, assessed via the contact length of the proximal and distal fracture segments on anteroposterior and lateral radiographs.
Measured: through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Mar 2019
- Primary completion15 Mar 2022
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Daniel Cognetti, Brooke Army Medical Center
- Investigators
- Daniel J Cognetti, MD, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716438
- Sponsor's protocol ID
- 2019.008
- Status last verified
- Jul 2026
- First submitted
- 15 Jan 2023
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Loss of Reduction and Cast Parameters Following Cast Bivalving for Pediatric Distal Radius Fractures
- ClinicalTrials.gov ID
- NCT05716438
- Acronym / sponsor ID
- 2019.008
- Keywords
- Cast, Pediatric, Cast Index, Distal Radius Fracture, Loss of Reduction, Bivalve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 8 Feb 2023 (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.
Pediatric patients with distal radius fractures are most commonly treated non-operatively with fracture reduction and cast immobilization. In order to prevent complications from increased swelling after the injury (or fracture manipulation) casts may be split along their length to relieve pressure. However, this can compromise the casts' structural integrity, predisposing fractures to loss of reduction. The goal of this study was to investigate if cast bivalving, or splitting the cast longitudinally on both sides, resulted in any immediate change to bony alignment and to assess if bivalving effected cast parameters associated with loss of reduction.
Detailed description
Displaced pediatric distal radius fractures are treated with fracture reduction and cast immobilization. Currently, at our institution (and many others) radiographic assessment to determine acceptable fracture alignment and cast parameters is done immediately after cast application. However, afterward casts are often split on both sides along their length, in a process known as bivalving, prophylactically treating for post-traumatic soft tissue edema. While bivalving is felt to relieve pressure from the cast, it may also diminish the structural integrity of the cast. Although it is well-established that loss of fracture alignment is most common in the first few weeks after fracture reduction there have been no studies to evaluate any immediate changes to fracture reduction or cast parameters that may occur after bivalving. Thus, the goal of this study was to assess if pediatric distal radius fracture alignment was affected by cast bivalving by obtaining post-bivalve radiographs in addition to standard post-cast radiographs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric patients with displaced distal radius fractures requiring reduction presenting to Brooke Army Medical Center within 72 hours of injury.
Key inclusion criteria (5 listed)
- Guardian must be present
- Able/eligible to complete follow-up
- Initial injury within 72 hours
- Distal Radius fracture with or without distal ulna fracture
- Requiring non-operative management with molded cast
Key exclusion criteria (7 listed)
- Open fractures
- Re-fractures
- Pathologic fractures
- Fractures associated with neurovascular injury
- Poly trauma incident
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 |
|---|---|---|
| Forearm anteroposterior and lateral plain radiograph2 view plain film of forearm after valving a short arm cast. | Radiation | – |
Primary outcome
Change in reduction after bivalving
Time frame: up to 24 hours
Change in fracture reduction of 2mm or 5 degrees in angulation on radiographs after bivalving
Change in reduction at follow-up
Time frame: up to 30 days
Change in fracture reduction of 2mm or 5 degrees in angulation on radiographs at follow-up
Cast Index
Time frame: through study completion, up to 2 years
Cast index, the ratio of sagittal to coronal width from the inside edges of the cast at the fracture site will be measured via radiographs.
Gap Index
Time frame: through study completion, up to 2 years
Gap index is a measure of space between the cast and skin measured as a ratio to the inside diameter of the cast, assessed at the level of the fracture on anteroposterior and lateral radiographs.
Three Point Index
Time frame: through study completion, up to 2 years
Three point index, a measure of space between the cast and skin at sites of the three point mold, with reference to the adequacy of reduction, assessed via the contact length of the proximal and distal fracture segments on anteroposterior and lateral radiographs.
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 14 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Daniel J Cognetti, MD principal investigator
Brooke Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Radius Fracture and Loss of Anatomical Alignment After Fracture Reduction, run by Brooke Army Medical Center 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 7 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 14 Jul 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 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?
Change in reduction after bivalving (time frame: up to 24 hours). The study lists 5 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 14 Jul 2026.