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Fitted orthosis versus plaster splint in postoperative rehabilitation after DRF fixation
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May 2015
Fitted orthosis versus plaster splint in postoperative rehabilitation after DRF fixation
Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A
Early functional postoperative therapy of distal radius fracture with a dynamic orthosis: results of a prospective randomized cross-over comparative study
PLoS One. 2015 Mar 30;10(3):e0117720Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
29 patients with displaced distal radius fracture were randomized in this cross-over trial comparing a vacuum-fitted orthosis and a plaster splint in postoperative rehabilitation. Following volar locking plate fixation, patients were randomized to one week orthosis wear followed by 3 weeks splint wear, or to one week splint wear followed by 3 weeks orthosis wear. Patient satisfaction and SF-36 scores were examined at 1 and 2 weeks after surgery, and range of motion and DASH scores were reported at 4 and 12 weeks after surgery. Aesthetics, handling, and hygiene were rated higher for the orthosis than the plaster splint, though no significant differences were noted in range of motion, SF-36 scores, or DASH scores.
Publication Funding Details
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Funding:
Industry funded
Sponsor:
OPED GmbH Medizinpark
Conflicts:
None disclosed
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
1/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
3/4
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?
Distal radius fractures are a commonly sustained injury, with an increasing trend in patients undergoing surgery for treatment, particularly in displaced fractures. While extensive research focus has been placed on different methods of surgical management, by comparison very little research has gone into postoperative management and optimal rehabilitation strategies. More specifically, methods and duration of immobilization remain points of interest. Traditionally, plaster casts have been implemented, but there has been interest in whether removable, dynamic orthoses may also be effective while offering better comfort.
What was the principal research question?
How does patient satisfaction and functional outcomes compare between patients treated with a dynamic orthosis versus a plaster cast following volar locking plate fixation of a displaced distal radius fracture?
Study Characteristics
-
Population:
29 patients (18-80 years of age) with displaced distal radius fracture (AO type 23 A2-3, B1-3, and C1-2) and underwent volar locking plate fixation
Intervention:
Orthosis/plaster cast group: At the end of the procedure, patients were fitted with the VacoHand orthosis (OPED GmbH) in a blocked setting (ie. locked in 20 degrees extension). At 1 week follow-up, the orthosis was removed and patients were fitted with a plaster of Paris forearm splint, which could be removed. Plaster splint wear was discontinued at 4 week follow-up. (n=15; Mean age: 50.93 +/- 15.18)
Comparison:
Plaster cast/orthosis group: At the end of the procedure, patients were fitted with a semicircumferential plaster of Paris splint. At 1 week follow-up, the splint was removed and patients were fitted with the VacoHand orthosis in an unblocked setting, allowing range of motion. The orthosis was discontinued at 4 week follow-up. (n=14; Mean age: 45.4 +/- 16.61).
Outcomes:
Primary outcome was outcome on a patient satisfaction questionnaire, administered at 1 and 2 weeks after surgery. Secondary outcomes included the Short Form 36 Item questionnaire (SF-36) at 1 and 2 weeks, and range of motion, the Disabilities of the Arm, Shoulder, and Hand questionnaire (DASH), and radiographic evaluation, all assessed at 4 and 12 weeks after surgery.
Methods:
RCT; Prospective, Cross-over
Time:
Follow-up conducted at 1, 2, 4, and 12 weeks after surgery.
What were the important findings?
- After the first week, patients who received the orthosis rated aesthetics significantly higher than those who received the splint (p<0.001), though difference after the cross-over was nonsignificant (p=0.719). Handling and hygiene were rated significantly higher with the orthosis versus the splint among those who received orthosis in the first week (p<0.001), and those who received the orthosis in the second week (p=0.001).
- No significant differences were noted between groups in the rating of activity limitation, physical resilience, fitting, or postoperative pain items within the patient-satisfaction questionnaire (all p>0.05).
- Preference for the orthosis was expressed in 23/29 patients (p=0.017).
- No statistically significant differences between groups were observed in range of motion, SF-36, or DASH scores.
What should I remember most?
Following surgical fixation of a displaced distal radius fracture, a vacuum-fitted orthosis was associated with greater patient satisfaction compared to a semicircumferential plaster splint with respect to aesthetics, handling, and hygiene, leading to greater patient preference. Patient-reported and function outcome did not significant differ in the short-term.
How will this affect the care of my patients?
The results of this study suggest that fitted orthoses, such as the VacoHand dynamic orthosis, may be more appealing to patients, although the increased patient satisfaction does not appear to lead to, or be the result of, improved clinical outcome. The cost-effectiveness of fitted orthoses should be considered in subsequent trials.
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