Clinical Evaluation of Cast21 Short Arm Product During Treatment of Distal Radial or Distal Ulnar Fractures (Cast21 SAP)

Cast21

Status

Not yet enrolling

Conditions

Fractures Bone

Ulna Fractures

Radius; Fracture, Lower or Distal End

Fracture

Radius Distal Fracture

Fractures

Fractures, Closed

Treatments

Device: Cast or brace alternative

Study type

Interventional

Funder types

Industry

Identifiers

NCT06304649

Cast21CHLA2023Study1SAP

Details and patient eligibility

About

The primary objective of this study will be the collection of preliminary clinical evidence to indicate that Cast21 Short Arm Product is no worse than the current standard of care arm immobilization devices in pediatric patients.

A secondary objective will be to characterize the clinician and patient experience with the Cast21 Short Arm Product.

Enrollment

60 estimated patients

Sex

All

Ages

3 to 21 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Demographic characteristics: all persons ages 3 and above, regardless of the race and sex will be eligible to participate in this study
Medical condition: participants must present with a closed, nondisplaced, or minimally displaced distal radius fracture and/or distal ulnar fracture that does not require a bone reduction procedure within 10 days from the date of injury
Sizing: participants eligible for the Cast21 Short Arm Product must undergo sizing conducted by the clinical staff to ensure fit into one of the products (sizes XS-L)

Exclusion criteria

Participants requiring a surgical intervention
Participants with moderately displaced or angulated fractures or fractures requiring a bone reduction procedure.
Participants with a known history of bone diseases e.g. osteogenesis imperfecta or other pathologic bone conditions
Participants with pathologic fractures e.g., presence of bone cyst
Participants who smoke
Participants with pre-existing skin infection or condition of the lower arm (participants exhibiting only minor skin abrasions, lacerations, or skin condition might be eligible per clinical investigator's discretion)