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

N/ANot Yet RecruitingNCT06304649

Cast2160 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 3 YearsMax age: 21 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Clinical determination of healing (standard of care)

A binary determination of healing after the intervention will be asserted by the clinician

Time frame: 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

Time frame: At treatment completion, an average of 4 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: At treatment completion, an average of 4 weeks

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes