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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fractures, Closed; Fractures; Fracture; Ulna Fractures; Radius Distal Fracture; Radius; Fracture, Lower or Distal End; Fractures Bone
• Intervention / Treatment: Device: Cast or brace alternative

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cast21 Short Arm Product	Device: Cast or brace alternative; Waterproof alternative to a cast or brace for broken bones

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical determination of healing (standard of care)	A binary determination of healing after the intervention will be asserted by the clinician	At treatment completion, an average of 4 weeks
Range of Motion (standard of care)	Clinicians will asses patients for a binary determination of Full Range of Motion or Limited Range of Motion	At treatment completion, an average of 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Outcomes - Pain	Patient pain scores with the Wong-Baker FACES Pain Rating Scale will be assessed. The rating scale is 1 (min) to 10 (max) with lower scores being a better outcome.	Before treatment (0 Days) and at treatment completion, an average of 4 weeks
Patient Reported Outcomes - Satisfaction	A questionnaire adapted from the Patient-Reported Outcomes Measurement Information System (PROMIS) scale will be administered. The scale is 1 (min) to 5 (max), with high scores indicating a better outcome.	At treatment completion, an average of 4 weeks
Physical Therapy Referral	A binary referral to physical therapy as part of the standard of care will be observed if the patient's range of motion (see Primary Outcome 2) is such that the clinician will refer more care.	At treatment completion, an average of 4 weeks

Collaborators and Investigators

• Sponsor: Cast21

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Fractures, Closed; Radius Fractures; Ulna Fractures
• Other Study ID Numbers: Cast21CHLA2023Study1SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No