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

Not Applicable

Not yet recruiting

• Conditions: Fractures, Closed; Fractures; Fractures Bone; Radius Distal Fracture; Fracture; Ulna Fractures; Radius; Fracture, Lower or Distal End
• Interventions: Device: Cast or brace alternative

• Registration Number: NCT06304649
• Lead Sponsor: Cast21

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-04
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-08
• Last Update Submitted: 2024-03-08
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12
• Study Start: 2024-04
• Primary Completion: 2024-10
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cast21 Short Arm Product	Cast or brace alternative	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Physical Therapy Referral	At treatment completion, an average of 4 weeks	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.
Patient Reported Outcomes - Pain	Before treatment (0 Days) and at treatment completion, an average of 4 weeks	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.
Patient Reported Outcomes - Satisfaction	At treatment completion, an average of 4 weeks	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.