NCT00590850

Non-Operative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures

A Multicenter, Prospective, Randomized Trial of Non-Operative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 412 (actual)
• Sponsor: Prisma Health-Upstate · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Clavicle (collar bone) fractures account for about 33% of all fractures around the shoulder. Some surgeons suggest that surgical treatment is the best option, while others suggest that nonoperative care is the best treatment. There is no evidence to date that either option in superior. For this reason, we propose to conduct a prospective, randomized clinical trial of surgical versus non-surgical treatment of displaced high-energy clavicle fractures. This study will use both objective clinical and patient-based outcome measures. The purpose of this study is to see if there is a difference between clinical outcomes (healing rate, time to healing, time to return to work, Constant Score, complications), functional outcomes (DASH Score), and health related quality of life (SF-36) in nonoperative care and two types of surgical care for displaced fractures of the clavicular shaft in adults. Included patients will be randomized into one of three groups: nonoperative care (Group N); surgical care using plates and screws (Group P); and surgical care using intramedullary pin put inside of the clavicle to stabilize it (Group I).

Conditions

• High Energy Midshaft Clavicle Fractures

Interventions

Type	Name	Description
PROCEDURE	ORIF with Plate and Screws	ORIF with plate and screws
PROCEDURE	Pin Fixation	Clavicle fixation with clavicle pin

Timeline

• Start date: 2003-10-01
• Primary completion: 2020-12-01
• Completion: 2023-10-01
• First posted: 2008-01-11
• Last updated: 2023-11-15

Locations

1 site across 1 country: United States