Prospective Evaluation of Cast Bivalving for Pediatric Distal Radius Fractures

NCT05716438 | Completed

• 1 other identifier: 2019.008
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Radius Fracture; Loss of Anatomical Alignment After Fracture Reduction

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Change in reduction after bivalving

  Change in fracture reduction of 2mm or 5 degrees in angulation on radiographs after bivalving

  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

  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.

  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.

  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.

  through study completion, up to 2 years

Other Outcomes (1)

• Complications

  through study completion, up to 2 years

Interventions

Forearm anteroposterior and lateral plain radiograph RADIATION

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

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients with displaced distal radius fractures requiring reduction presenting to Brooke Army Medical Center within 72 hours of injury.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Daniel J Cognetti, MD

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: January 15, 2023
• First Posted: February 8, 2023
• Study Start: March 1, 2019
• Primary Completion: March 15, 2022
• Study Completion: July 15, 2023
• Last Updated: July 14, 2026

Record last verified: 2026-07

Locations

US (1)