Prospective Evaluation of Cast Bivalving for Pediatric Distal Radius Fractures

Distal Radius Fracture Clinical Trial

Official title:

Prospective Evaluation of Loss of Reduction and Cast Parameters Following Cast Bivalving for Pediatric Distal Radius Fractures

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05716438
• Other study ID #: 2019.008
• Status: Active, not recruiting
• Start date: March 1, 2019
• Est. completion date: April 20, 2023

Study information

• Verified date: January 2023
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: April 20, 2023
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Radiation:
• Forearm anteroposterior and lateral plain radiograph
2 view plain film of forearm after valving a short arm cast.

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications	Surgical intervention, cast saw burns, physeal arrest, refracture (after enrollment)	through study completion, up to 2 years
Primary	Change in reduction after bivalving	Change in fracture reduction of 2mm or 5 degrees in angulation on radiographs after bivalving	up to 24 hours
Primary	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
Primary	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
Primary	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
Primary	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