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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Distal Radius Fracture; Loss of Anatomical Alignment After Fracture Reduction
• Intervention / Treatment: Radiation: Forearm anteroposterior and lateral plain radiograph

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • Brooke Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Surgical intervention, cast saw burns, physeal arrest, refracture (after enrollment)	through study completion, up to 2 years

Collaborators and Investigators

• Sponsor: Brooke Army Medical Center
• Investigators: Principal Investigator: Daniel J Cognetti, MD, Brooke Army Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ACTUAL): March 15, 2022
• Study Completion (ANTICIPATED): April 20, 2023

Study Registration Dates

• First Submitted: January 15, 2023
• First Submitted That Met QC Criteria: January 28, 2023
• First Posted (ACTUAL): February 8, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: January 28, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Pediatric; Distal Radius Fracture; Cast; Cast Index; Loss of Reduction; Bivalve
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: 2019.008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No