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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06304649
Other study ID # Cast21CHLA2023Study1SAP
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2024
Est. completion date December 2024

Study information

Verified date March 2024
Source Cast21
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 2024
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 3 Years to 21 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Cast or brace alternative
Waterproof alternative to a cast or brace for broken bones

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cast21

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary 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
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