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

NCT06304649 | Not Yet Recruiting

• 1 other identifier: Cast21CHLA2023Study1SAP
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Patient Reported Outcomes - Pain

  Before treatment (0 Days) and at treatment completion, an average of 4 weeks

• Patient Reported Outcomes - Satisfaction

  At treatment completion, an average of 4 weeks

• Physical Therapy Referral

  At treatment completion, an average of 4 weeks

Study Arms (1)

Cast21 Short Arm Product

EXPERIMENTAL

Device: Cast or brace alternative

Interventions

Cast or brace alternative DEVICE

Waterproof alternative to a cast or brace for broken bones

Cast21 Short Arm Product

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cast21: lead

MeSH Terms

Conditions

Fractures, Closed; Fractures, Bone; Ulna Fractures; Wrist Fractures

Condition Hierarchy (Ancestors)

Wounds and Injuries; Forearm Injuries; Arm Injuries; Wrist Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: March 12, 2024
• Study Start: April 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03