Clinical trial NCT03724773: Long-Arm vs Sugar-Tong
Official title: Outcomes of Long-Arm Casting Versus Sugar-Tong Splinting of Displaced Forearm Shaft Fractures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Closed Fracture of Shaft of Ulna
Closed Fracture of Shaft of Radius
Keywords: Closed Reduction
Sugar-Tong Splint
Long-Arm Cast
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2018-10-30
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Single or both bone forearm shaft fractures, follow-up at the St. Louis Children's Hospital and affiliated branches

Exclusion Criteria:

* Children below 4 or above 12 years of age
* Distal radius/ulna fracture(s)
* Distal radius/ulna third shaft fracture(s)
* Proximal radius/ulna third shaft fracture(s)
* Radius/ulna fracture(s) not requiring reduction
* Open radius/ulna fracture(s)
* Radius/ulna fracture(s) requiring open reduction in the operating room
* Patient with metabolic defects
* Pathologic radius/ulna fracture(s)
* Previous fractures in the same location (radius/ulna)

Primary outcomes:
measure: Radiographic measurements
timeFrame: 1 week
measure: Radiographic measurements
timeFrame: 2 weeks
measure: Radiographic measurements
timeFrame: 4 weeks
measure: Radiographic measurements
timeFrame: 6 weeks
measure: Radiographic measurements
timeFrame: 1 week
measure: Radiographic measurements
timeFrame: 2 weeks
measure: Radiographic measurements
timeFrame: 4 weeks
measure: Radiographic measurements
timeFrame: 6 weeks
measure: Radiographic measurements
timeFrame: 1 week
measure: Radiographic measurements
timeFrame: 2 weeks
measure: Radiographic measurements
timeFrame: 4 weeks
measure: Radiographic measurements
timeFrame: 6 weeks
measure: Radiographic measurements
timeFrame: 1 week
measure: Radiographic measurements
timeFrame: 2 weeks
measure: Radiographic measurements
timeFrame: 4 weeks
measure: Radiographic measurements
timeFrame: 6 weeks
Secondary outcomes:
measure: Clinical follow-up
timeFrame: 1 week
measure: Clinical follow-up
timeFrame: 2 weeks
measure: Clinical follow-up
timeFrame: 4 weeks
measure: Clinical follow-up
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
Study officials:
References:
citation: Bohm ER, Bubbar V, Yong Hing K, Dzus A. Above and below-the-elbow plaster casts for distal forearm fractures in children. A randomized controlled trial. J Bone Joint Surg Am. 2006 Jan;88(1):1-8. doi: 10.2106/JBJS.E.00320.
citation: Levy J, Ernat J, Song D, Cook JB, Judd D, Shaha S. Outcomes of long-arm casting versus double-sugar-tong splinting of acute pediatric distal forearm fractures. J Pediatr Orthop. 2015 Jan;35(1):11-7. doi: 10.1097/BPO.0000000000000196.
citation: Kamat AS, Pierse N, Devane P, Mutimer J, Horne G. Redefining the cast index: the optimum technique to reduce redisplacement in pediatric distal forearm fractures. J Pediatr Orthop. 2012 Dec;32(8):787-91. doi: 10.1097/BPO.0b013e318272474d.
citation: Alemdaroglu KB, Iltar S, Cimen O, Uysal M, Alagoz E, Atlihan D. Risk factors in redisplacement of distal radial fractures in children. J Bone Joint Surg Am. 2008 Jun;90(6):1224-30. doi: 10.2106/JBJS.G.00624.