Study Comparing Plate Stabilization to Conservative Treatment in Midshaft Clavicle Fractures

Helsinki University Central Hospital (HUCH)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Fracture; Clavicle

Treatments: Procedure: Operative treatment; Procedure: Non-operative treatment with arm immobilised to a sling

Study type: Interventional

Funder types: Other

Identifiers

NCT01199653

T102020Z12 (Other Identifier)

TYH6267

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Non-operative treatment

Active Comparator group

Description:

Non-operative (conservative) treatment of the clavicle fracture

Treatment:

Procedure: Non-operative treatment with arm immobilised to a sling

Operative treatment

Active Comparator group

Description:

Operative stabilization (i.e. ORIF) of the fracture with a plate and screws.

Treatment:

Procedure: Operative treatment