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RCT
ACE Report #5290

Splint as effective as a cast in children with minimally angulated distal radius fractures


Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A

Cast versus splint in children with minimally angulated fractures of the distal radius: a randomized controlled trial

CMAJ. 2010 Oct 5;182(14):1507-12

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Synopsis

96 children with a minimally angulated greenstick or transverse fracture of the wrist were randomized to receive either a wrist splint or a short arm cast for 4 weeks. The children were assessed for physical function at 6 weeks and degree of angulation at 4 weeks. Range of motion, grip strength, and complications were also noted. The two groups were not found to have significant differences for any of the outcome measures.

Publication Funding Details +
Funding:
Non-Industry funded
Sponsor:
SickKids Foundation and the Discovery Grant Program of the Natural Sciences and Engineering Research Council of Canada.
Conflicts:
None disclosed

Risk of Bias

7/10

Reporting Criteria

20/20

Fragility Index

N/A

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

4/4

Randomization

4/4

Outcome Measurements

4/4

Inclusion / Exclusion

4/4

Therapy Description

4/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.

Why was this study needed now?

Minimally angulated (15 degrees or less) distal radius fractures in children do not usually require reduction and are most commonly treated with a short arm cast for 4-6 weeks. Negative features of a cast include poor hygiene, risks from a poor fit, and discomfort. Splinting may be a viable alternative based on studies in adults, though a direct comparison with casting in children is needed before recommendations can be made.

What was the principal research question?

Is a prefabricated wrist splint as effective as routine casting in the recovery of physical function in children with a minimally angulated distal radius fracture at 6 weeks?

Study Characteristics -
Population:
92 children between 5 and 12 years with minimally angulated acute greenstick or transverse fractures of the metaphyseal portion of the distal radius.
Intervention:
Splint: Patients were placed in a wrist splint for 4 weeks and instructed not to remove it except for hygienic reasons as needed (n=46).
Comparison:
Cast: Patients were placed in a fiberglass cast for 4 weeks (n=50).
Outcomes:
The primary outcome was physical function at 6 weeks (assessed with the performance version of the Activities Scale for Kids: questionnaire with 30 items relating to children's and clinicians' perspectives on pediatric and wrist daily activities). Additional outcomes were fracture angulation, wrist pain (assessed with the Faces Pain Scale--Revised), range of motion (goniometer), grip strength (dynamometer), and patient preference for their device.
Methods:
RCT: Single center: Single blinded.
Time:
Patients assessed at 1 and 4 weeks (fracture angulation and wrist pain), and at 6 weeks (wrist pain, range of motion, grip strength, physical function, and preference).

What were the important findings?

  • At 6 weeks, the physical function score was a mean of 92.8 in the splint group compared to a mean of 91.4 in the cast group. The mean difference between the groups was 1.44 (95% CI -1.75-4.62). This was not a significant difference.
  • At 1 week, the mean angulation of the splint group was 8.65 degrees compared to 7.92 degrees for the cast group. The mean difference was -2.43 (95% CI -2.43-3.90) and not significant. At 4 weeks the mean angulation had increased to a mean of 9.85 degrees in the splint group and 8.20 in the cast group for a mean difference of -1.65 (95% CI -1.82-5.11), which was not significant.
  • The range of motion at 6 weeks was not significantly different between the groups.
  • Grip strength at 6 weeks was not significantly different between groups, with a mean of 26.6 pounds in the splint group and 28.8 pounds in the cast group (mean difference of -2.16, 95% CI -7.34-3.02).
  • The wrist pain score was not significantly different between groups at any time point.
  • In terms of patient preference, 12% of the patients in the splint group would have preferred casting treatment. In contrast, 68% of patients in the cast group reported a preference for splinting. This difference in patient preference was significant (p<0.001). In addition, 5% of parents of children assigned to splinting expressed a preference for casting, whereas 60% of parents of children in the cast group would have preferred a splint (p<0.001).

What should I remember most?

The use of a prefabricated splint was shown to have similar effectiveness to a cast in terms of patient function and fracture stability. In addition, the splint was associated with a higher level of patient and parental satisfaction.

How will this affect the care of my patients?

Due to what appear to be similar outcomes but different levels of patient convenience and satisfaction, the use of a splint may be a preferred alternative to casting in the treatment of minimally angulated distal radius fractures. The authors note that the sample size may have been too small to detect differences in all outcome measures.

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luc racine 2017-10-02 5:52 PM

Orthopaedic Surgeon - Canada

confirme pratique