An interventional study of Cast or brace alternative in Fractures, Closed, Fractures Bone and Fracture, sponsored by Cast21. Not yet recruiting. Open to participants aged 3 Years to 21 Years. Per ClinicalTrials.gov, last updated 2024-03-12.
Sponsored by Cast21 · Not applicable, Interventional, and Treatment
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.
44 studies on the registry are indexed under Fractures, Closed; 4 are open to participants now.
This study's planned enrollment of 60 is above the median of 45 across 34 interventional studies indexed under Fractures, Closed.
Browse Fractures, Closed studies →This is the only study on the registry with Cast21 as lead sponsor.
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Exclusion Criteria:
Device: Cast or brace alternative
Waterproof alternative to a cast or brace for broken bones
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
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
No study locations are listed for this record.
Start is estimated for Apr 2024; primary completion for Oct 2024, 6 months later.
Of 14 interventional studies with no phase under Fractures, Closed, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 49. This study's planned 6 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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