A Randomized Trial Comparing Conventional Plaster and Thermoplastic Splints to Treat Pediatric Boxer's Fractures
|ClinicalTrials.gov Identifier: NCT01759758|
Recruitment Status : Completed
First Posted : January 3, 2013
Last Update Posted : January 13, 2016
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?
|Condition or disease||Intervention/treatment||Phase|
|Bone Fractures Splints Metacarpal Fracture Boxer's Fracture||Other: Plaster Ulnar Gutter Splint Other: Thermoplastic Splint||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Conventional Plaster Versus Thermoplastic Splint for the Treatment of a Pediatric Metacarpal Neck Fracture: a Randomized Trial|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Active Comparator: Plaster Ulnar Gutter Splint
Patients 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
Other: Plaster Ulnar Gutter Splint
Patients are placed in a plaster ulnar gutter splint, molded in the safe position.
Experimental: Thermoplastic Splint
Patients will be fitted with a custom molded thermoplastic splint that stabilizes the metacarpals of the injured hand but does not immobilize any joints
Other: Thermoplastic Splint
Thermoplastic 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.
- Range of Motion [ Time Frame: up to 12 weeks ]The active and passive Range of Motion (ROM) will be tested at 3 time points, for all fingers and the wrist
- Compliance [ Time Frame: 3 weeks post fracture ]The compliance rate of subjects in each group wearing the splint at all times for the prescribed duration (3 weeks) will be assessed.
- Pain [ Time Frame: 1, 3, 6, and 12 weeks post fracture ]Pain, reported on a Visual Analog Scale, will be assessed at specified time points
- Complications [ Time Frame: 3, 6, and 12 weeks ]Loss of fracture reduction, malunion or non-union will be monitored throughout the study
- Validated Outcome Questionnaire [ Time Frame: 3, 6, and 12 weeks ]Patients will complete the Pediatric Outcomes Data Collection Instrument (PODCI) at several time points
- Grip Strength [ Time Frame: 6 and 12 weeks ]Patients will have their grip strength measured for the injured and non-injured hand at 6 and 12 weeks post fracture
- Radiographic assessment of fracture [ Time Frame: 12 weeks post fracture ]An X-ray of the injured had will be done in 3 views. This will be assessed by one of the investigators, in a blinded fashion. They will determine the angulation and assess for evidence of bony healing
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01759758
|Canada, Nova Scotia|
|IWK Health Centre|
|Halifax, Nova Scotia, Canada, B3K6R8|
|Principal Investigator:||Michael Bezuhly, MD, MSc, SM||Assistant Professor, Clinician-Investigator at IWK Health Centre and Dalhousie University|