Prospective Evaluation of Cast Bivalving for Pediatric Distal Radius Fractures

NCT ID: NCT05716438

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2023-04-20

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.

Conditions

Distal Radius Fracture; Loss of Anatomical Alignment After Fracture Reduction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Forearm anteroposterior and lateral plain radiograph

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

Intervention Type: RADIATION

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brooke Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Daniel Cognetti

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel J Cognetti, MD

Role: PRINCIPAL_INVESTIGATOR

Brooke Army Medical Center

Locations

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Countries

United States

Other Identifiers

2019.008

Identifier Type: -

Identifier Source: org_study_id