Efficacy of Self - Adjustable Clavicular Brace Versus Standard Clavicular Brace for Treatment of Mid Shaft Clavicle Fracture: A Randomized Controlled Study

Prince of Songkla University68 enrolled

Overview

A randomized control trial was conducted to compare the outcomes of conservative management for closed midshaft clavicular fractures using self-adjustable clavicular brace and standard clavicular brace.

Ten patients aged 18-75 years with midshaft clavicle fractures were enrolled in the study during February 2022 to February 2023. 6 patients were managed with standard clavicular brace and 4 patients with self-adjustable clavicular brace. All patients were scheduled for follow-up appointments at 1 week, 2 weeks, 4 weeks, 6 weeks and 12 weeks. Results were assessed based on clinical, functional and radiographic outcomes using the DASH questionnaire, pain, measured by VAS, analgesic usage, displacement, shortening, time to union, and patient satisfaction,

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Clavicle Fracture

Interventions

Clavicular braceDEVICE

Clavicular brace for conservative treatment of closed midshaft clavicular fractures

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with aged between 18 - 75 years old * Closed isolated fracture midshaft of clavicle within 9 days after the injury date Exclusion Criteria: * After bracing, fracture displacement and/or shortening \> 2 cm or fracture comminution \> 3 fragments * Segmental fracture * Open fracture * Impending open fracture (soft tissue compromise/skin lesion) * Ipsilateral upper extremities fracture which disturbs clavicular bracing * Floating shoulder which surgical treatment is indicated. * Patients with other injuries (e.g. head injury, chest and abdomen injury) which interrupted clavicular bracing * Pathologic fracture * Patient has limitation for clavicular brace application * Pregnant women

Locations (1)

Prince of Songkla University

Songkhla, Hatyai, Thailand

RECRUITING

Outcomes

Primary Outcomes

DASH

DISABILITIES OF THE ARM, SHOULDER AND HAND

Time frame: 1, 2, 4, 6, 12 week

Secondary Outcomes

Pain, analgesic usage, radiographic outcomes, time to union, and patient satisfaction

Time frame: 1, 2, 4, 6, 12 week

Data from ClinicalTrials.gov

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