A Randomized Control Trial of Splinting vs. Casting for Toddlers Fractures in Children

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A Randomized Control Trial of Splinting vs.
Casting for Toddlers Fractures in Children

• Lisa Dyke, MD, FRCPC
• Clinical Instructor
• University of British Columbia
• Division of Emergency Medicine
• Department of Pediatrics
• B.C. Childrens Hospital

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Co-Investigators

• Dr. Navid Dehghani
• Dr. Martin Pusic
• Dr. Stephen Tredwell
• Dr. Rini Jain
• Dr. Adam Bretholz
• Ruth Milner

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Disclosure
? I do not have an affiliation (financial or
otherwise) with any commercial organization that
may have a direct or indirect connection to the
content of my presentation. ? I have/had an
affiliation (financial or otherwise) with a
commercial organization that may have a direct or
indirect connection to the content of my
presentation.
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Definition of a Toddlers Fracture

• Non-displaced, spiral fracture of the mid to
  distal tibial shaft
• Main presenting feature is abnormal gait
• Clinical radiologic findings can be subtle
• Inherently stable
• Current treatment is AK cast for 3-6 weeks

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Objective

• To determine if treating children diagnosed with
  a toddlers fracture with a splint for one week
  results in
• Earlier return to pre-injury activity level
  (i.e.. walking with no limp)
• No compromise in healing or pain control
• Less complicated treatment course

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Methods

• Prospective, randomized control trial
• Sugar-tong splint
• Standard AK cast
• Emergency Department at B.C.C.H
• Consent obtained on every patient
• Randomized in blocks of 6
• Analysis blinded

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Cast Splint
With tensor wrapped overtop
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Parent Pain Measure

• Completed daily for the first 7 days
• Parents were asked to fill it out at the same
  time every day
• Suggested after putting the child to bed
• This has been adapted from the Parents
  Postoperative Pain Measure.
• Reference Chanbers, C.T., Reid, G.J.,
  McGrath, P.J., Finley, G.A. (1996).
  Development and preliminary validation of a
  postoperative pain measure for parents. Pain, 68,
  307-313.

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Day 1 ________________   Children sometimes
have changes in behavior when recovering from an
injury. The following is a list of behaviors
your child may or may not have exhibited today.
  For each of the behaviors below, enter the
appropriate response, yes or no.   Today did your
child   1) Whine or complain more than usual?
. Yes No 2) Cry more easily than
usual? . Yes No 3) Play
less than usual? .
Yes No 4) Not do the things s/he normally does?
Yes No 5) Act more worried than
usual? .. Yes No 6) Act more
quiet than usual? . Yes
No 7) Have less energy than usual?
. Yes No 8) Refuse to eat?
Yes No 9) Eat less
than usual? .
Yes No 10) Hold the sore part of his/her body?
. Yes No 11) Try not to bump
the sore part of his/her body? . Yes
No 12) Groan or moan more than usual?
. Yes No 13) Look more flushed
than usual? . Yes No 14) Want
to be close to you more than usual? .
Yes No 15) Take medication when s/he
normally refuses? .. Yes No
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Daily Parent Log

• Completed daily for 6 weeks
• DAY 1 _____________
•  
• For each of the following, enter the appropriate
  response, yes or no.
•  
• 1) Is she/he able to walk?
  Yes No
• 2) Is she/he limping? .
  Yes No
• 3) Is your childs activity level back to
• normal? ................................
  ................ Yes No
• 4) Is your child able to do the activities
• they did prior to the injury?
  Yes No

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Statistical Analysis

• Sample size was calculated using a two-sample
  comparison of means
• Our assumptions included an alpha of 0.05
  (two-sided) and a power of 0.8
• We hypothesized that all children in the cast
  group would walk at 3 weeks. The SD was
  estimated to be 1 week in order to detect a 1
  week improvement in time to normal walking
• This gave us a required sample size of 22 in each
  group

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Results
Patients meeting eligibility criteria presenting
to the ED (n 89)
Excluded (n 43) Not meeting inclusion criteria
(n 2) Unable to arrange follow-up (n2) Language
barrier (n2) Refused to consent to enter trial
(n8) Missed enrollment (n2) No study person
available (n4) Injury diagnosed treated
elsewhere (n3) Injury gt 1wk old, no treatment
(n9) No fracture on x-ray, no treatment (n11)
Enrollment
Randomized?
Randomized to control group CAST (n24) Excluded
due to wrong diagnosis (n2) Withdrew after
randomization (n 3)
Randomized to intervention group SPLINT (n 22)
Allocation
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Lost to follow-up (n 0) No 6-week visit (n1)
Lost to follow-up (n0) No 6 week visit (n1)
Follow-Up
Analyzed SPLINT (n22)
Analyzed CAST (n 19)
Analysis
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Results 41 patients analyzed

• 22 Splint
• Initial
• 7 (32) x-ray pos
• 15 (68) x-ray neg
• Final
• 13 (59) true TF
• 9 (41) not a TF
• No on f/u films
• no third film done (1)
• MT (1)
• Prox tibial (1)

• 19 Cast
• Initial
• 7 (37) x-ray pos
• 12 (63) x-ray neg
• Final
• 16 (84) true TF
• 3 (16) not a TF
• No on f/u film (1)
• Fibular (1)
• Prox tibial (1)

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Patient Characteristics
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Examination
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Outcome - Limping
CAST
Percentage Limping
SPLINT



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Outcome Limping

• Statistically significant difference in limping
  at 3 weeks and 6 weeks in favor of SPLINT
• 3 weeks 62 difference (95 CI 41,85)
• 6 weeks 53 difference (95 CI 27,80)

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Outcome

• There was no significant difference in time to
  walking or time off work for parents in either
  treatment group

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Pain Diary
cast
splint
Pain considered clinically significant if parents
answered yes for 6/15 questions
percent
day of diary
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Outcome

• Calf Circumference
• There was no difference in measured calf
  circumference in either treatment group
• There were no complications in either treatment
  group

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Limitations

• The study personnel were not blinded to treatment
  groups at follow-up
• More patients in the CAST group had true
  toddlers fracture as compared to the SPLINT
  group
• 84 vs. 59

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Conclusion

• Patients in the intervention group had
• Earlier return to pre-injury activity level
• No difference in pain control
• Below knee sugar tong splint is an acceptable
  treatment for patients diagnosed with a toddlers
  fracture