An interventional study of Long-Arm Cast and Sugar-Tong Splint in Closed Fracture of Shaft of Ulna and Closed Fracture of Shaft of Radius, sponsored by Washington University School of Medicine. Withdrawn at 1 site in United States. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2019-10-24.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether a sugar-tong splint is as effective as a long-arm cast in maintaining reduction of pediatric forearm shaft fractures in a randomized, prospective manner. Consented participants will be randomly assigned to be treated with either a sugar-tong splint or a long-arm cast (both standard of care treatments) in REDCap. Each participant will have a 50/50 chance of being assign to either treatment.
Forearm fractures are very common in the pediatric population and can often be treated with closed reduction and immobilization. Immobilization techniques include long-arm casting, short-arm casting and sugar-tong splinting. At the time of injury casts are usually split into two using a cast saw, known as bivalving, to allow for swelling and are overwrapped at a later time. By design sugar-tong splints allow for swelling and are overwrapped or converted to a cast at a later time. Traditionally long-arm casts have been used as the standard mode of immobilization for forearm fractures. Recent evidence demonstrates that long-arm casting is equivalent to better tolerated short-arm casting as an immobilization choice for distal third forearm fractures.1 Further work has shown that sugar-tong splints are also appropriate for treatment of distal third forearm fractures. No study has compared the efficacy of using a long-arm cast versus a sugar-tong splint for treatment of forearm shaft fractures.
44 studies on the registry are indexed under Fractures, Closed; 4 are open to participants now.
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Exclusion Criteria:
Reduction and long-arm cast application will be performed by PGY-1 and up residents with adequate training and/or supervision in the required techniques.
Device: Long-Arm Cast
Reduction and sugar-tong splint application will be performed by PGY-1 and up residents with adequate training and/or supervision in the required techniques.
Device: Sugar-Tong Splint
A long-arm cast is a circumferential wrapping of the arm from the fingers to above the elbow with casting material.
A sugar-tong splint is the application of hard splinting material on the front and back of the arm.
Radiographic measurements
Measure sagittal angulation
Time frame: 1 week
Radiographic measurements
Measure sagittal angulation
Time frame: 2 weeks
Radiographic measurements
Measure sagittal angulation
Time frame: 4 weeks
Radiographic measurements
Measure sagittal angulation
Time frame: 6 weeks
Radiographic measurements
Coronal angulation
Time frame: 1 week
Radiographic measurements
Coronal angulation
Time frame: 2 weeks
Radiographic measurements
Coronal angulation
Time frame: 4 weeks
Radiographic measurements
Coronal angulation
Time frame: 6 weeks
Radiographic measurements
Displacement
Time frame: 1 week
Radiographic measurements
Displacement
Time frame: 2 weeks
Radiographic measurements
Displacement
Time frame: 4 weeks
Radiographic measurements
Displacement
Time frame: 6 weeks
Radiographic measurements
Percent displacement
Time frame: 1 week
Radiographic measurements
Percent displacement
Time frame: 2 weeks
Radiographic measurements
Percent displacement
Time frame: 4 weeks
Radiographic measurements
Percent displacement
Time frame: 6 weeks
Clinical follow-up
Treatment information
Time frame: 1 week
Clinical follow-up
Treatment information
Time frame: 2 weeks
Clinical follow-up
Treatment information
Time frame: 4 weeks
Clinical follow-up
Treatment information
Time frame: 6 weeks
This study is withdrawn, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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