Conservative Treatment Compared to Osteosynthesis in Patients With a Fractured Collar Bone

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

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2015-12-31

Brief Summary

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This study will compare non-operative treatment of displaced midshaft collarbone fractures with operative treatment using a precontoured titanium plate and screws.

The study hypothesis is that operation will provide better pain relief, faster return to activities, better function of the involved upper limb, and lower the risk of a non healing fracture (non union).

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Detailed Description

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Conditions

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Displaced Midshaft Fracture of the Collar Bone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arm sling treatment

Displaced midshaft fracture of the collar bone treated with an arm sling

Group Type EXPERIMENTAL

Displaced midshaft fracture of the collar bone

Intervention Type PROCEDURE

Displaced midshaft fracture of the collar bone treated with an arm sling

Operation

Displaced midshaft fracture of the collar bone treated with operation using a pre contoured titanium plate and screws.

Group Type EXPERIMENTAL

Operation using a precontoured titanium plate and screws

Intervention Type PROCEDURE

Operation using a precontoured titanium plate and screws

Interventions

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Operation using a precontoured titanium plate and screws

Intervention Type PROCEDURE

Displaced midshaft fracture of the collar bone

Displaced midshaft fracture of the collar bone treated with an arm sling

Intervention Type PROCEDURE

Other Intervention Names

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No other names. No other names.

Eligibility Criteria

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Inclusion Criteria

* fracture located to the mid third of the collar bone where there is no contact between the fractured surface of the main fragments on x-ray in one or two of two levels.

Exclusion Criteria

* bilateral fracture
* imminent skin perforation
* open fracture
* associated neurovascular effect
* unstable fracture of neck of scapula "floating shoulder"
* fracture of coincidental upper extremity distal for the shoulder
* pathologic fracture
* the patient states that there was a unilateral or bilateral shoulder problem before the fracture
* fracture realized more than 14 days after it arose
* circumstances which make it impossible to carry out one of the two regimes, i.e. mental illness and abuse
* circumstances which make follow-up impossible, i.e. address far from the including departments and stays abroad of long duration
* medical contraindication against surgery or general anaesthesia
* former participation in the trial
* former fracture contra/ipsilateral at the age of 15 or older

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No