NCT01199653

Study Comparing Plate Stabilization to Conservative Treatment in Midshaft Clavicle Fractures

Nonoperative Versus Operative Treatment of Midshaft Clavicle Fractures - A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Clavicle
• Fracture

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2004-08-01
• Primary completion: 2007-10-01
• Completion: 2009-11-01
• First posted: 2010-09-13
• Last updated: 2010-09-13

Locations

1 site across 1 country: Finland