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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2024-02-16

Brief Summary

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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.

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Detailed Description

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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,

Conditions

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Clavicle Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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self-adjustable clavicular brace

Group Type EXPERIMENTAL

Clavicular brace

Intervention Type DEVICE

Clavicular brace for conservative treatment of closed midshaft clavicular fractures

standard clavicular brace

Group Type ACTIVE_COMPARATOR

Clavicular brace

Intervention Type DEVICE

Clavicular brace for conservative treatment of closed midshaft clavicular fractures

Interventions

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Clavicular brace

Clavicular brace for conservative treatment of closed midshaft clavicular fractures

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes