Conservative Interventions for Treating Clavicle Fractures in Adults

NCT ID: NCT02398006

Last Updated: 2015-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-12-31

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.

Conditions

Fracture of Clavicle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1: a standard arm sling

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 Type: ACTIVE_COMPARATOR

a standard arm sling

Intervention Type: OTHER

Closed reduction (re-aligning the fragments of the fracture) will be not performed because the reduced position is practically impossible to maintain.

Group 2: a figure-of-eight bandage

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).

Group Type: ACTIVE_COMPARATOR

a figure-of-eight bandage

Intervention Type: OTHER

Closed reduction (re-aligning the fragments of the fracture) will be not performed because the reduced position is practically impossible to maintain.

Interventions

a standard arm sling

Closed reduction (re-aligning the fragments of the fracture) will be not performed because the reduced position is practically impossible to maintain.

Intervention Type: OTHER

a figure-of-eight bandage

Closed reduction (re-aligning the fragments of the fracture) will be not performed because the reduced position is practically impossible to maintain.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Israelita Albert Einstein

OTHER

Sponsor Role: lead

Responsible Party

Mario Lenza

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mario Lenza, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Israelita Albert Einstein

Central Contacts

Mario Lenza, PhD

Role: CONTACT

mario.lenza@einstein.br

55 11 21511444

Mario Ferretti, PhD

Role: CONTACT

ferretti@einstein.br

55 11 21511444

References

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.

Reference Type: DERIVED

PMID: 27142768 (View on PubMed)

Other Identifiers

HIAE orthopaedics

Identifier Type: -

Identifier Source: org_study_id