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Completed

NCT Number: NCT05716438

Prospective Evaluation of 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.

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Key information

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Forearm anteroposterior and lateral plain radiograph

Radiation

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

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

Other outcomes

  1. Complications

    Time frame: through study completion, up to 2 years

    Surgical intervention, cast saw burns, physeal arrest, refracture (after enrollment)

Sponsors and collaborators

Lead sponsor

Brooke Army Medical Center

Fed

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Feb 8, 2023
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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