Study Comparing Plate Stabilization to Conservative Treatment in Midshaft Clavicle Fractures

Phase 2

Completed

• Conditions: Clavicle; Fracture
• Interventions: Procedure: Operative treatment; Procedure: Non-operative treatment with arm immobilised to a sling

• Registration Number: NCT01199653
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

The purpose of this study is to find whether to operate or treat conservatively dislocated midshaft clavicle fractures.

Detailed Description

Midshaft clavicle fractures are common comprising 2% of all fractures and 35% to 45% of all shoulder girdle injuries in adults. Old-established treatment practices, based on no randomised controlled trials, are used for clavicle fractures. By tradition, midshaft clavicle fractures have been treated conservatively with arm immobilized to a sling for few weeks. The goal of treatment is to restore painless function of the upper extremity.

There have been some recommendations for operative treatment, such as skin compromising in fracture area, open fracture, floating shoulder, neurovascular symptoms in upper extremity, or multiple injuries. Recently, increasing interest has emerged in the surgical treatment.

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2007-10
• Study Completion: 2009-11
• Status Verified: 2010-09
• Study First Submitted: 2010-09-10
• Study First Submitted QC: 2010-09-10
• Last Update Submitted: 2010-09-10
• Study First Posted: 2010-09-13
• Last Update Posted: 2010-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• a completely displaced middle third clavicle fracture, no cortical contact between main fragments
• fresh fracture, treatment within seven days after injury
• age between 18 and 70 years
• provided informed consent

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Exclusion Criteria

• fracture was not dislocated
• multiple injured patient
• associated neurovascular injury, or suspicion of it
• reduced cooperation
• cancer or any severe illness impairing health
• pathological fracture
• treatment seven days after injury
• open fracture
• corticosteroid or immunosuppressive medication
• upper extremity fracture at same time
• an earlier clavicle or shoulder region fracture
• pregnancy
• lack of consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Operative treatment	Operative treatment	Operative stabilization (i.e. ORIF) of the fracture with a plate and screws.
Non-operative treatment	Non-operative treatment with arm immobilised to a sling	Non-operative (conservative) treatment of the clavicle fracture

Primary Outcome Measures

Name	Time	Method
Shoulder function	Two years	Shoulder Function is measured by Constant shoulder Score (CS) is a outcome measure for assessing the outcomes of the treatment of shoulder disorders.It inclues the pain score, functional assessment, range of motion and strength measures.

Secondary Outcome Measures

Name	Time	Method
Complications	Continous till two years	Number of participants who are confronted complications such as nonunion, malunion, infection, hardware breakdown or hardware irritation.
Disabilities of the Arm, Shoulder and Hand (DASH)	Two years	The DASH is a self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb.
Pain at rest and at activity	Two years	Pain in measured with Visual Analogue Scale (VAS) which is a psychometric response scale. It is a measurement instrument for subjective characteristics that cannot be measured directly
Pain at rest and activity	Six weeks	Pain in measured with Visual Analogue Scale (VAS) which is a psychometric response scale. It is a measurement instrument for subjective characteristics that cannot be measured directly.
Disability of the Arm, Shoulder and Hand (DASH)	One year	The DASH is a self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb.
Fracture healing	Two years	Fracture healing is examined from Xray.

Trial Locations

Locations (1)

Helsinki University Central Hospital, Töölö Hospital; 🇫🇮 Helsinki, Uusimaa, Finland