Modified "Providence" Pedi Cast-Sling vs.Cast and Sling

Lifespan

Status: Completed

Conditions: Pediatric ALL; Fractures, Bone

Treatments: Device: Providence Pedi Cast-Sling; Device: Regular sling

Study type: Interventional

Funder types: Other

Identifiers

NCT03192683

400316

Details and patient eligibility

About

Examining custom made sling vs. off the shelf sling for immobilization following pediatric upper extremity fractures.

Enrollment: 71 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients aged 0-18 years old who were evaluated in the pediatric emergency department (ED) by the orthopaedic resident on call
• patients with an upper extremity fracture (wrist, forearm or elbow) that required placement of a long-arm cast.

Exclusion criteria

• open fractures
• fractures at multiple levels (e.g. wrist AND elbow fracture)
• fractures requiring immediate/urgent surgery
• patients requiring admission for any reason
• bivalved LAC's for any reason

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Regular sling

Active Comparator group

Treatment:

Device: Regular sling

Cast-sling

Experimental group

Treatment:

Device: Providence Pedi Cast-Sling