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RCT
ACE Report #5366

Treating closed mallet finger with Quickcast reduces edema & improves DIP joint extension


Study Type:Therapy
OE Level Evidence:1
Journal Level of Evidence:N/A

Effectiveness of cast immobilization in comparison to the gold-standard self-removal orthotic intervention for closed mallet fingers: A randomized clinical trial

J Hand Ther. 2013 Jul-Sep;26(3):191-201. doi: 10.1016/j.jht.2013.01.004. Epub 2013 Feb 27

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Synopsis

60 patients with distal interphalangeal joint (DIPj) active extensor lag were randomized to determine the efficacy between cast immobilization treatment using either a Quickcast orthosis to be worn 24 hours a day or a removable, low temperature thermoplastic, lever-type orthosis. After 24-28 weeks, there were no significant differences between the two groups in regard to success rate, orthosis discomfort, satisfaction with orthotic design, DIPj flexion stiffness, incidence of complications, and grip and tip-to-tip pinch strengths. However, the Quickcast group experienced significantly greater active extension at the distal interphalangeal joint at 10-12 weeks and significantly less edema at 6-8 weeks compared to the low temperature thermoplastic, lever-type orthosis group.

Publication Funding Details +
Funding:
Non-funded
Conflicts:
None disclosed

Risk of Bias

8/10

Reporting Criteria

18/20

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

3/4

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?

Mallet finger occurs when the extensor terminal tendon in the long fingers is either lacerated or ruptured. Although this injury can be treated surgically, conservative methods where the distal interphalangeal joint (DIPj) is immobilized are usually preferred. However, it is unclear what type of immobilization device is the most appropriate in handling this injury. Therefore this study aimed to compare efficacy of treating closed mallet fingers using a cast worn 24 hours a day versus a removable, lever-type thermoplastic orthosis.

What was the principal research question?

Is cast immobilization of Type I mallet finger injuries more effective with Quickcast or a self-removable, thermoplastic, lever-type orthosis, measured over 24-28 weeks?

Study Characteristics -
Population:
60 patients with at least 20 degree distal interphalangeal joint active extensor lag for less than 90 days who lived within 75 km of the Hand Center (Age range: >18) (n=57 patients completed follow-up)
Intervention:
LTTP Group: After entering the emergency room, patients were given a removable, custom-fabricated low temperature thermoplastic (LTTP), lever-type orthosis that covered the distal phalanx circumferentially and stretched downward towards the middle phalanx. The bottom of the orthosis was held in place with 1/2 inch paper adhesive tape. For the first 6-8 weeks patients were advised to remove the orthosis once a day to allow for skin care. Afterwards patients were instructed to remove their orthosis 6-8 times a day to perform metacarpal phalangeal flexion blocking exercises. At 7-9 weeks, patients began performing active fisting exercises. At 8-10 weeks, patients were told to only wear the orthosis at night. After 10-12 weeks, they were told to discontinue wearing the orthosis at all (Mean age: 47.1 +/- 14.5) (n=30)
Comparison:
QC Group: After entering the emergency room, patients were given a custom-fabricated Quickcast (QC) orthosis to wear for 6-8 weeks that they were advised not to remove during that period. The orthosis covered the distal and middle phalanges circumferentially with the bottom of the orthosis held in place with adhesive tape. At 6-8 weeks patients were given the same LTTP orthosis as the LTTP group. Afterwards patients followed the same protocol as described for the LTTP group for weeks 6-28 (Mean age: 42.7 +/- 12.9) (n=30; 27 completed follow-up)
Outcomes:
The primary outcome measures were distal interphalangeal joint (DIPj) extensor lag, dichotomous success rating, and range of motion (ROM) (measured dorsally using a flat Baseline 15 cm metal arm goniometer). Secondary outcome measures included presence of finger edema (measured using 15 different Oval-8 Ring Sizers which were fitted around the finger until the smallest acceptable sizer could not go past the midway section of the middle phalanx, DIPj, and distal phalanx of the finger), orthosis discomfort, subjective aesthetic assessment of orthosis, satisfaction with final outcome (all three measured using a visual analogue scale (VAS)), DIPj flexion stiffness, grip and tip-to-tip pinch strength (measured using a E-Link Dynamometer System), and the incidence of complications
Methods:
RCT: single-center; single-blinded (outcome assessor)
Time:
Outcomes were measured at baseline and at 3-4, 6-8, 7-9, 8-10, 10-12, 12-14, and at 24-28 weeks

What were the important findings?

  • At the 10-12 week evaluation, the QC group had a mean of 5° more active extension at the DIPj compared to the LTTP group (p=0.05). It was also determined that there was a correlation between edema and active extension, where the lower the edema, the more active extension at the DIPj (p=0.003).
  • There was no significant difference in the orthosis success rate between the LTTP group (60%) and the QC group (81%) (Chi-squared: 3.31; Degrees of freedom: 1; p=0.08).
  • ¬-At the 6-8 week assessment, significantly less edema was experienced in the QC group (0.4 +/- 0.9), compared to the LTTP group (1.1 +/- 0.8) (p=0.03). At all other time points there was no significant difference between groups.
  • At the 3-4 week assessment there was no significant difference in median VAS pain scores between the LTTP group (0.2 cm) and the QC group (0.6 cm) (Wilcoxon Rank Sum (WRS) test: p=0.14). However, at the 6-8 week assessment median pain scores were significantly lower in the LTTP group (0 cm), compared to the QC group (0.4 cm) (WRS test: p=0.03).
  • At the final 24-28 week evaluation there were no significant differences in mean VAS outcome satisfaction scores based on the orthotic design between the LTTP group (1.8 cm) and the QC group (1.0 cm) (p=0.23).
  • There were no significant differences between the two groups in regard to active DIPj flexion stiffness, grip, and tip-to-tip pinch strength at any time point throughout the 28 weeks. At the final 24-28 week assessment nearly full recovery of both grip strength and pinch strength comparative to the uninjured finger were achieved for both the QC group (Grip strength: 96%; Pinch strength: 90.8%) and the LTTP group (Grip strength: 98.2%; Pinch strength: 93.4%).
  • None of patients reported any cases of severe skin complications, such as ulcerations or necrosis.

What should I remember most?

Following 24-28 weeks, the results of this study indicated that there were similarities between the Quickcast and custom-fabricated low temperature thermoplastic, lever-type orthosis groups regarding success rate, orthosis discomfort, satisfaction with orthotic design, distal interphalangeal joint flexion stiffness, incidence of complications, and grip and tip-to-tip pinch strengths. However, the Quickcast group experienced significantly greater active extension at the distal interphalangeal joint and less edema.

How will this affect the care of my patients?

Both the Quickcast and custom-fabricated low temperature thermoplastic, lever-type orthosis provide effective treatment of distal interphalangeal joint active extensor lag following injury. However, Quickcast may be a more suitable immobilization device as in this study less edema and more active extension at the distal interphalangeal joint were associated with this orthosis. In order to improve success rates further research is required to determine what the optimal immobilization period and orthosis discontinuation process are following a mallet finger injury.

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