Clavicle FractureNCT06276218
Efficacy of Self - Adjustable Clavicular Brace Versus Standard Clavicular Brace for Treatment of Mid Shaft Clavicle Fracture: A Randomized Controlled Study
A study testing Clavicular brace in people with Clavicle Fracture, run by Prince of Songkla University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Clavicle Fracture
- What is being tested?
- Clavicular brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteThailand
- Study dates
- 1 Feb 2022to 16 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient with aged between 18 - 75 years old
- Closed isolated fracture midshaft of clavicle within 9 days after the injury date
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Prince of Songkla University
Songkhla, Hatyai, 90110
Thanachai Klongsangsorn, +66991964733, poom_thanachai@hotmail.com
About this study
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.
Read the 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,
- Conditions
- Clavicle Fracture
- Being tested
- Clavicular brace
- Keywords
- Clavicle fracture, treatment of clavicle fracture, clavicular brace, figure of eight bandage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clavicular braceDevice
Clavicular brace for conservative treatment of closed midshaft clavicular fractures
| Study group | Role | What they receive |
|---|---|---|
| self-adjustable clavicular brace | Experimental | Not described Receives: Device: Clavicular brace |
| standard clavicular brace | Active comparator | Not described Receives: Device: Clavicular brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASH
DISABILITIES OF THE ARM, SHOULDER AND HAND
Measured: 1, 2, 4, 6, 12 week
Secondary outcomes (1)
Pain, analgesic usage, radiographic outcomes, time to union, and patient satisfaction
Pain, analgesic usage, radiographic outcomes, time to union, and patient satisfaction
Measured: 1, 2, 4, 6, 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start1 Feb 2022
- Primary completion15 Feb 2024
- Study completion16 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clavicle FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thanachai Klongsangsorn, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276218
- Sponsor's protocol ID
- PSU
- Status last verified
- Feb 2024
- First submitted
- 18 Feb 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Self - Adjustable Clavicular Brace Versus Standard Clavicular Brace for Treatment of Mid Shaft Clavicle Fracture: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06276218
- Acronym / sponsor ID
- PSU
- Conditions
- Clavicle Fracture
- Keywords
- Clavicle fracture, treatment of clavicle fracture, clavicular brace, figure of eight bandage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 16 Feb 2024 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| self-adjustable clavicular brace | Experimental | Device: Clavicular brace |
| standard clavicular brace | Active comparator | Device: Clavicular brace |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with aged between 18 - 75 years old
- Closed isolated fracture midshaft of clavicle within 9 days after the injury date
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clavicular braceClavicular brace for conservative treatment of closed midshaft clavicular fractures | Device | self-adjustable clavicular brace, standard clavicular brace |
Primary outcome
DASH
Time frame: 1, 2, 4, 6, 12 week
DISABILITIES OF THE ARM, SHOULDER AND HAND
1 secondary outcome
Pain, analgesic usage, radiographic outcomes, time to union, and patient satisfaction
Time frame: 1, 2, 4, 6, 12 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clavicular brace in people with Clavicle Fracture, run by Prince of Songkla University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DASH (time frame: 1, 2, 4, 6, 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.