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

NCT ID: NCT06304649

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2024-12-31

Brief Summary

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.

Conditions

Fractures, Closed; Fractures Bone; Fracture; Fractures; Radius; Fracture, Lower or Distal End; Ulna Fractures; Radius Distal Fracture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cast21 Short Arm Product

Group Type: EXPERIMENTAL

Cast or brace alternative

Intervention Type: DEVICE

Waterproof alternative to a cast or brace for broken bones

Interventions

Cast or brace alternative

Waterproof alternative to a cast or brace for broken bones

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cast21

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Cast21CHLA2023Study1SAP

Identifier Type: -

Identifier Source: org_study_id