Clinical trial NCT05716438: Prospective Evaluation of Cast Bivalving for Pediatric Distal Radius Fractures
Official title: Prospective Evaluation of Loss of Reduction and Cast Parameters Following Cast Bivalving for Pediatric Distal Radius Fractures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Distal Radius Fracture
Loss of Anatomical Alignment After Fracture Reduction
Keywords: Cast
Pediatric
Cast Index
Distal Radius Fracture
Loss of Reduction
Bivalve
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2023-02-08
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in reduction after bivalving
timeFrame: up to 24 hours
measure: Change in reduction at follow-up
timeFrame: up to 30 days
measure: Cast Index
timeFrame: through study completion, up to 2 years
measure: Gap Index
timeFrame: through study completion, up to 2 years
measure: Three Point Index
timeFrame: through study completion, up to 2 years
Secondary outcomes:
Other outcomes:
measure: Complications
timeFrame: through study completion, up to 2 years
Locations:
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Brooke Army Medical Center
name: Daniel J Cognetti, MD
role: PRINCIPAL_INVESTIGATOR
References: