Clinical trial NCT02398006: Conservative Interventions for Treating Clavicle Fractures in Adults
Official title: Figure-of-eight Bandage Versus Arm Sling for Treating Middle Third Clavicle Fractures in Adults: Study Protocol for a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fracture of Clavicle
Keywords: Clavicle [mh]
Fracture Healing [mh]
Fractures, Bone [mh]
Treatment outcome [mh]
Conservative treatment [tw]
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2015-03-25
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: Whilst there are several options for conservative treatment for middle third clavicle fractures, only two randomised controlled published in the 80s attempted to determine the effects of different methods for conservative treatment for middle third clavicle fractures. Thus, a pragmatic trial design has been chosen as it can directly inform clinical practice; our inclusion criteria will reflect the variety in patient presentations that would be encountered by general orthopaedic surgeons in the clinical setting. The current trial includes design characteristics known to minimise bias. Participants will be assigned using a concealed random procedure, assessments and data analysis will be blinded and we will use the intention-to-treat analysis.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years or older and 65 years or less with middle third clavicle fracture,
* Acute fracture (less than 10 days), we will include all types of middle third clavicle fractures (non-displaced and displaced fractures),
* No medical contraindication to proposed methods of immobilisation,
* Understanding of Portuguese language and written informed consent.

Exclusion Criteria:

* Pathological fracture,
* Open fracture,
* Neurovascular injury on physical examination,
* Associated head injury (Glasgow Coma Scale score of \<12),
* Ipsilateral upper limb fractures and/or dislocation(except hand and fingers),
* History of frozen shoulder,
* Previous disease in the limb that could influence the results (e.g. rheumatoid arthritis),
* Inability to comply with follow-up (inability to read or complete forms).

Primary outcomes:
measure: Function or disability will be measured by DASH - Disability of the Arm, Shoulder, and Hand questionnaire
timeFrame: 12 months
Secondary outcomes:
measure: Modified University of California at Los Angeles (modified - UCLA)
timeFrame: 12 months
measure: Pain measured on a 0 to 100 using visual analogue scale (VAS)
timeFrame: 12 months
measure: Treatment failure measured by the number of participants who have undergone or are being considered a surgical intervention
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
measure: Numbers returning to previous activities (work, sport, activities of daily living), including time to return.
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Mario Lenza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.