Study Comparing Plate Stabilization to Conservative Treatment in Midshaft Clavicle Fractures

• Shoulder function [ Time Frame: Three months ] [ Designated as safety issue: No ]
  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.
• Shoulder function [ Time Frame: One year ] [ Designated as safety issue: No ]
  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.
• Shoulder function [ Time Frame: Two years ] [ Designated as safety issue: No ]
  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.

• Disability of the Arm, Shoulder and Hand (DASH) [ Time Frame: Three months ] [ Designated as safety issue: No ]
  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 activity [ Time Frame: Three weeks ] [ Designated as safety issue: No ]
  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.
• Fracture healing [ Time Frame: Three months ] [ Designated as safety issue: No ]
  Fracture healing is examined from Xray.
• Complications [ Time Frame: Continous till two years ] [ Designated as safety issue: Yes ]
  Number of participants who are confronted complications such as nonunion, malunion, infection, hardware breakdown or hardware irritation.
• Disability of the Arm, Shoulder and Hand (DASH) [ Time Frame: One year ] [ Designated as safety issue: No ]
  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.
• Disabilities of the Arm, Shoulder and Hand (DASH) [ Time Frame: Two years ] [ Designated as safety issue: No ]
  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 activity [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
  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 at activity [ Time Frame: Three months ] [ Designated as safety issue: No ]
  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 at activity [ Time Frame: One year ] [ Designated as safety issue: No ]
  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 at activity [ Time Frame: Two years ] [ Designated as safety issue: No ]
  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
• Fracture healing [ Time Frame: One year ] [ Designated as safety issue: No ]
  Fracture healing is examined from Xray.
• Fracture healing [ Time Frame: Two years ] [ Designated as safety issue: No ]
  Fracture healing is examined from Xray.

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.

• Clavicle
• Fracture

• Procedure: Operative treatment
  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.
• Procedure: Non-operative treatment with arm immobilised to a sling
  Arm is immobilised to a sling for three weeks. Pendulum movements are allowed immediately.

• Active Comparator: Non-operative treatment
  Non-operative (conservative) treatment of the clavicle fracture
  Intervention: Procedure: Non-operative treatment with arm immobilised to a sling
• Active Comparator: Operative treatment
  Operative stabilization (i.e. ORIF) of the fracture with a plate and screws.
  Intervention: Procedure: Operative treatment

• Canadian Orthopaedic Trauma Society. Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. A multicenter, randomized clinical trial. J Bone Joint Surg Am. 2007 Jan;89(1):1-10.
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• Zlowodzki M, Zelle BA, Cole PA, Jeray K, McKee MD; Evidence-Based Orthopaedic Trauma Working Group. Treatment of acute midshaft clavicle fractures: systematic review of 2144 fractures: on behalf of the Evidence-Based Orthopaedic Trauma Working Group. J Orthop Trauma. 2005 Aug;19(7):504-7. Review.

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