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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cast21 Short Arm Product | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cast or brace alternative | Device | Waterproof alternative to a cast or brace for broken bones |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Patient Reported Outcomes - Satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
| 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 |
| ID | Term |
|---|---|
| D005596 | Fractures, Closed |
| D050723 | Fractures, Bone |
| D014458 | Ulna Fractures |
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D005543 | Forearm Injuries |
| D001134 | Arm Injuries |
| D014954 | Wrist Injuries |
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