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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06276218

Enrollment

Registered

2024-02-23

Start date

2022-02-01

Completion date

2024-02-16

Last updated

2024-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clavicle Fracture

Keywords

Clavicle fracture, treatment of clavicle fracture, clavicular brace, figure of eight bandage

Brief summary

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.

Detailed description

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,

Interventions

DEVICEClavicular brace

Clavicular brace for conservative treatment of closed midshaft clavicular fractures

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
DASH	1, 2, 4, 6, 12 week	DISABILITIES OF THE ARM, SHOULDER AND HAND

Secondary

Measure	Time frame	Description
Pain, analgesic usage, radiographic outcomes, time to union, and patient satisfaction	1, 2, 4, 6, 12 week	Pain, analgesic usage, radiographic outcomes, time to union, and patient satisfaction

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026