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

Launched by CAST21 · Mar 8, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to evaluate a new product called the Cast21 Short Arm Product for treating certain types of fractures in children and adults. The main goal is to see if this new cast is as effective as the traditional arm immobilization devices currently used. The trial will also gather feedback from doctors and patients about their experiences with this new casting option.

To be eligible for the study, participants must be aged 3 and older and have a specific type of fracture called a distal radius or distal ulnar fracture that does not need surgery. Importantly, the fractures must not be severely displaced or angulated, and participants should be able to fit into one of the available cast sizes. Those with certain medical conditions or who smoke will not be able to participate. The trial is not yet recruiting, but when it starts, participants can expect to receive the Cast21 Short Arm Product and share their experiences during the treatment process.

Gender

ALL

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)