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Prospective Evaluation of Cast Bivalving for Pediatric Distal Radius Fractures

Prospective Evaluation of Loss of Reduction and Cast Parameters Following Cast Bivalving for Pediatric Distal Radius Fractures

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05716438
Enrollment
60
Registered
2023-02-08
Start date
2019-03-01
Completion date
2023-07-15
Last updated
2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Radius Fracture, Loss of Anatomical Alignment After Fracture Reduction

Keywords

Cast, Pediatric, Cast Index, Distal Radius Fracture, Loss of Reduction, Bivalve

Brief 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. 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.

Interventions

RADIATIONForearm anteroposterior and lateral plain radiograph

2 view plain film of forearm after valving a short arm cast.

Sponsors

Brooke Army Medical Center
Lead SponsorFED

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in reduction after bivalvingup to 24 hoursChange in fracture reduction of 2mm or 5 degrees in angulation on radiographs after bivalving
Change in reduction at follow-upup to 30 daysChange in fracture reduction of 2mm or 5 degrees in angulation on radiographs at follow-up
Cast Indexthrough study completion, up to 2 yearsCast 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 Indexthrough study completion, up to 2 yearsGap 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 Indexthrough study completion, up to 2 yearsThree 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDaniel J Cognetti, MD

Brooke Army Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 15, 2026