The Treatment of Clavicular Fractures

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

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-05-27

Brief Summary

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Patients with a displaced, shortened, midshaft clavicular fracture are randomized in two groups: conservative or operative treatment. The conservative arm is treated with a sling for 6 weeks. The operative arm is treated with osteosynthesis, within 2 weeks.

Patients are clinically and radiologically evaluated during 1 year. A economical analysis is also done.

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Detailed Description

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Conditions

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Displaced, Midshaft Clavicular Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

operative treatment

Group Type EXPERIMENTAL

osteosynthesis

Intervention Type PROCEDURE

operative treatment

2

conservative treatment

Group Type ACTIVE_COMPARATOR

sling

Intervention Type OTHER

conservative treatment

Interventions

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osteosynthesis

operative treatment

Intervention Type PROCEDURE

sling

conservative treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 to 65 year
* 100% displaced midshaft clavicular fracture
* shortening

* male: 18mm
* female: 14mm

Exclusion Criteria

* pregnancy
* pathological fracture
* open fracture
* history of frozen shoulder
* ipsilateral fracture of shoulder or scapula
* neurovascular injury
* contraindication to anaesthesia

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No