The Treatment of Clavicular Fractures

Ghent University Hospital (UZ)

Status: Completed

Conditions: Displaced, Midshaft Clavicular Fractures

Treatments: Other: sling; Procedure: osteosynthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT00642265

2007/573

Details and patient eligibility

About

Patients with a displaced, shortened, midshaft clavicular fracture are randomized in two groups: conservative or operative treatment. The conservative arm is treated with a sling for 6 weeks. The operative arm is treated with osteosynthesis, within 2 weeks.

Patients are clinically and radiologically evaluated during 1 year. A economical analysis is also done.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 65 year

• 100% displaced midshaft clavicular fracture

• shortening

  • male: 18mm
  • female: 14mm

Exclusion criteria

• pregnancy
• pathological fracture
• open fracture
• history of frozen shoulder
• ipsilateral fracture of shoulder or scapula
• neurovascular injury
• contraindication to anaesthesia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

1

Experimental group

Description:

operative treatment

Treatment:

Procedure: osteosynthesis

2

Active Comparator group

Description:

conservative treatment

Treatment:

Other: sling