Conservative Interventions for Treating Clavicle Fractures in Adults

Fracture of Clavicle Clinical Trial

Official title:

Figure-of-eight Bandage Versus Arm Sling for Treating Middle Third Clavicle Fractures in Adults: Study Protocol for a Randomised Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02398006
• Other study ID #: HIAE orthopaedics
• Status: Not yet recruiting
• Phase: N/A
• First received: March 12, 2015
• Last updated: March 19, 2015
• Start date: April 2015
• Est. completion date: December 2017

Study information

• Verified date: March 2015
• Source: Hospital Israelita Albert Einstein
• Contact: Mario Lenza, PhD
• Phone: 55 11 21511444
• Email: mario.lenza[@]einstein.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: December 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fracture of Clavicle
• Fractures, Bone

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Modified University of California at Los Angeles (modified - UCLA)	Modified University of California at Los Angeles (modified - UCLA), validated and translated into Portuguese in Brazil.	12 months	Yes
Secondary	Pain measured on a 0 to 100 using visual analogue scale (VAS)	Pain measured on a 0 to 100 using visual analogue scale (VAS) (with 0 indicating no pain and 100 indicating the maximum pain). As reported in the literature, a clinically important change will be considered as a 30% or more change in pain score.	12 months	Yes
Secondary	Treatment failure measured by the number of participants who have undergone or are being considered a surgical intervention	Treatment failure measured by the number of participants who have undergone or are being considered a surgical intervention (e.g. symptomatic non-union or malunion with intractable pain). Although studies evaluating patients with fractures without displacement reported low rates of nonunion (about 0.03%), studies with patients with displaced fractures found nonunion rates of up to 15%. Therefore, we expect between 5 and 10% of our participants might provide symptomatic nonunion during follow-up. Patients who experience this complication during follow-up study will be treated surgically with open reduction and internal fixation with pre-contoured locking plate counted down the superior surface of the clavicle and bone grafting when necessary.	12 months	Yes
Secondary	Adverse events	Adverse events measured by: a) Cosmetic result: perception of deformity or asymmetric result (dichotomous data); b) Asymptomatic non-union (i.e. the fracture has not healed radiographically with no pain); c) Stiffness/restricted of range of shoulder movement (compared with contralateral side).	12 months	Yes
Secondary	Numbers returning to previous activities (work, sport, activities of daily living), including time to return.	Numbers returning to previous activities (work, sport, activities of daily living), including time to return.	12 months	Yes