Prospective Evaluation of Cast Bivalving for Pediatric Distal Radius Fractures
- Conditions
- Distal Radius FractureLoss of Anatomical Alignment After Fracture Reduction
- Registration Number
- NCT05716438
- Lead Sponsor
- Brooke Army Medical Center
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in reduction after bivalving up to 24 hours Change in fracture reduction of 2mm or 5 degrees in angulation on radiographs after bivalving
Cast Index 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.
Change in reduction at follow-up up to 30 days Change in fracture reduction of 2mm or 5 degrees in angulation on radiographs at follow-up
Gap Index 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States