Prospective Evaluation of Cast Bivalving for Pediatric Distal Radius Fractures

Sponsor
Brooke Army Medical Center (U.S. Fed)
Overall Status
Active, not recruiting
CT.gov ID
NCT05716438
Collaborator
(none)
60
1
49.6
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Evaluation of Loss of Reduction and Cast Parameters Following Cast Bivalving for Pediatric Distal Radius Fractures
Actual Study Start Date :
Mar 1, 2019
Actual Primary Completion Date :
Mar 15, 2022
Anticipated Study Completion Date :
Apr 20, 2023

Outcome Measures

Primary Outcome Measures

  1. Change in reduction after bivalving [up to 24 hours]

    Change in fracture reduction of 2mm or 5 degrees in angulation on radiographs after bivalving

  2. 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

  3. 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.

  4. 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.

  5. 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.

Other Outcome Measures

  1. Complications [through study completion, up to 2 years]

    Surgical intervention, cast saw burns, physeal arrest, refracture (after enrollment)

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brooke Army Medical Center Fort Sam Houston Texas United States 78234

Sponsors and Collaborators

  • Brooke Army Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daniel Cognetti, Primary Investigator, Brooke Army Medical Center
ClinicalTrials.gov Identifier:
NCT05716438
Other Study ID Numbers:
  • 2019.008
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Daniel Cognetti, Primary Investigator, Brooke Army Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2023