Study Comparing Plate Stabilization to Conservative Treatment in Midshaft Clavicle Fractures

Phase 3CompletedNCT01199653

Helsinki University Central Hospital60 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Clavicle Fracture

Interventions

Operative treatmentPROCEDURE

Fracture stabilization with stainless steel reconstruction plate and screws. After the operation arm is immobilized to a sling for three weeks. Pendulum movements are allowed immediately.

Non-operative treatment with arm immobilised to a slingPROCEDURE

Arm is immobilised to a sling for three weeks. Pendulum movements are allowed immediately.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 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

Locations (1)

Helsinki University Central Hospital, Töölö Hospital

Helsinki, Uusimaa, Finland

Outcomes

Primary Outcomes

Shoulder function

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.

Time frame: Three months

Shoulder function

Time frame: One year

Shoulder function

Time frame: Two years

Secondary Outcomes

Disability of the Arm, Shoulder and Hand (DASH)

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.

Time frame: Three months

Pain at rest and activity

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.

Time frame: Three weeks

Fracture healing

Fracture healing is examined from Xray.

Time frame: Three months

Complications

Data from ClinicalTrials.gov

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