Bone Fractures | A Randomized Trial Comparing Conventional Plaster and Thermoplastic Splints to Treat Pediatric Boxer's Fractures
Bone Fractures research study
What is the primary objective of this study?
The investigators are conducting a randomized clinical trial comparing two types of splints for treatment of Boxer's fractures in children up to age 17 inclusive. Patients who meet inclusion criteria will be randomized to either Group A or B. Group A will be treated with the conventional plaster ulnar gutter splint. Group B will be treated with a custom molded thermoplastic hand-based splint. The thermoplastic splint will provide support of the metacarpal but does not immobilize the patient's wrist or interphalangeal joints. Hypothesis: Is plaster splint immobilization an equivalent treatment method to a custom made thermoplastic splint for a fifth metacarpal neck fracture? Will one splint be tolerated better than the other and will the compliance be different between the two groups?
Who is eligible to participate?
Inclusion Criteria: - Isolated 5th metacarpal neck fracture - Less than 10 days from injury Exclusion Criteria: - Multiple Metacarpal fractures - Significant injuries to other hand structures (tendons, nerves, major arteries)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:Plaster Ulnar Gutter SplintPatients are placed in a plaster ulnar gutter splint, molded in the safe position.
Other:Thermoplastic SplintThermoplastic Splint is heat moulded to the patient's hand, stabilizing the metacarpal heads, but not immobilizing any joints. This is done by our occupational therapist.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Plaster Ulnar Gutter SplintPatients will have their hand placed in a conventional Plaster ulnar gutter splint. This immobilizes all joints of the ring and small fingers and the wrist
Thermoplastic SplintPatients will be fitted with a custom molded thermoplastic splint that stabilizes the metacarpals of the injured hand but does not immobilize any joints
Start Date: December 2012
Completed Date: June 2014
Primary Outcome: Range of Motion
Secondary Outcome: Pain
Study sponsors, principal investigator, and references
Principal Investigator: Michael Bezuhly, MD, MSc, SM
Lead Sponsor: IWK Health Centre
Hunter JM, Cowen NJ. Fifth metacarpal fractures in a compensation clinic population. A report on one hundred and thirty-three cases. J Bone Joint Surg Am. 1970 Sep;52(6):1159-65.