NCT06276218

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

February 18, 2024

Last Update Submit

February 18, 2024

Conditions

Clavicle Fracture

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • DASH

    DISABILITIES OF THE ARM, SHOULDER AND HAND

    1, 2, 4, 6, 12 week

Secondary Outcomes (1)

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

    1, 2, 4, 6, 12 week

Study Arms (2)

self-adjustable clavicular brace

EXPERIMENTAL
Device: Clavicular brace

standard clavicular brace

ACTIVE COMPARATOR
Device: Clavicular brace

Interventions

Clavicular braceDEVICE

Clavicular brace for conservative treatment of closed midshaft clavicular fractures

self-adjustable clavicular bracestandard clavicular brace

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with aged between 18 - 75 years old
  • Closed isolated fracture midshaft of clavicle within 9 days after the injury date

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Songkla University

Songkhla, Hatyai, 90110, Thailand

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 18, 2024

First Posted

February 23, 2024

Study Start

February 1, 2022

Primary Completion

February 15, 2024

Study Completion

February 16, 2024

Last Updated

February 23, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)