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Figure-of-eight Bandage Versus Arm Sling for Treating Middle Third Clavicle Fractures in Adults: Study Protocol for a Randomised Controlled Trial
Sponsor study identifier
interventional
110
0 countries
N/A
Study Start
April 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Background: Fracture of the clavicle is common accounting for 2.6% to 4 % of all fractures, with an overall incidence of 36.5 to 64 per 100,000 per year. Around 80% of clavicle fractures occur in the middle third of the clavicle. There is a lack of evidence of randomised controlled trials assessing the best treatment of these fractures. The objective of this study is to evaluate the effects (benefits and harms) of conservative interventions: figure-of-eight bandage versus sling for the treating middle third clavicle fractures. Methods/Design: this project has been designed as a single-centre, parallel-group randomised controlled trial that will compare figure-of-eight bandage versus sling. The investigators aim to recruit 110 adults, aged 18 years or older, with an acute (less than 10 days) middle third clavicle fracture. Primary outcomes will be function or disability measured by DASH questionnaire; the secondary outcomes will be: modified UCLA score pain, treatment failure, adverse events and numbers returning to previous activities. Data analysis: the chi-square test will be used to analyse the results of categorical variables, and Student t-test will be used to compare groups with respect to the numerical variables. The Student t-test is used to compare the clinical outcome of each group at 1, 2 and 4 weeks and at 6 and 12 months after the intervention. The significance level of 5% (alpha = 0.05) is used for all statistical tests such that tests have a value of less than 0.05 are considered statistically significant. Discussion: According to current evidence there is very limited evidence from two single trials only regarding the effectiveness of different methods of conservative interventions for treating clavicle fractures. This study is one of the first randomised controlled trials following the CONSORT statements designed to compare two conservative methods for treating clavicle fractures (figure-of-eight versus sling).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2017
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 12, 2015
Actual (reported)March 25, 2015
Actual (reported)April 2015
Date type not reportedThis date has not been verified as actual or estimated.
September 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Function or disability will be measured by DASH - Disability of the Arm, Shoulder, and Hand questionnaire
Function or disability will be measured by DASH - Disability of the Arm, Shoulder, and Hand questionnaire validated and translated into Portuguese in Brazil, the final score of the DASH questionnaire will be converted to a percentage via the following formula: Scoring = \[Sum of answers n/n - 1\] X 25, where n is the number of complete answers. The two optional modules will not be measured. The value obtained will be directly proportional to the percentage of impairment of the limb function.
12 months
Modified University of California at Los Angeles (modified - UCLA)
12 months
Pain measured on a 0 to 100 using visual analogue scale (VAS)
12 months
Treatment failure measured by the number of participants who have undergone or are being considered a surgical intervention
12 months
Adverse events
12 months
Numbers returning to previous activities (work, sport, activities of daily living), including time to return.
12 months
Group 1: the orthopaedic surgeon will apply a standard arm sling that will be used for four weeks; however, during these weeks, participants will be encouraged to discard the sling when their pain has subsided. After four weeks the same orientations of group 1 will be done to this group.
Group 2: a figure-of-eight bandage will be used for four weeks, and every week the participants will return to check and adjust the immobilisation. In this way, the dominant hand can remain free and simple activities will be allowed (writing, keyboarding and other). After four weeks, participants will be encouraged to discard the bandage, but load bearing will not be allowed before osseous consolidation (around 10 weeks).
Closed reduction (re-aligning the fragments of the fracture) will be not performed because the reduced position is practically impossible to maintain.
Closed reduction (re-aligning the fragments of the fracture) will be not performed because the reduced position is practically impossible to maintain.
Lenza M, Taniguchi LF, Ferretti M. Figure-of-eight bandage versus arm sling for treating middle-third clavicle fractures in adults: study protocol for a randomised controlled trial. Trials. 2016 May 4;17(1):229. doi: 10.1186/s13063-016-1355-8.
Mario Lenza, PhD
Hospital Israelita Albert Einstein
First Submitted
March 12, 2015
First Posted
March 25, 2015
Study Start
April 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2016
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 25, 2015
Record last verified: 2015-03
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