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

Fracture Clinical Trial

— Cast21 SAP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06304649
• Other study ID #: Cast21CHLA2023Study1SAP
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Cast21
• Contact: n/a
• Is FDA regulated: No
• 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)

Related Conditions & MeSH terms

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

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