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

Not Applicable

Completed

• Conditions: High Energy Midshaft Clavicle Fractures
• Interventions: Procedure: ORIF with Plate and Screws; Procedure: Pin Fixation

• Registration Number: NCT00590850
• Lead Sponsor: Prisma Health-Upstate

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2007-12-28
• Study First Submitted QC: 2007-12-28
• Study First Posted: 2008-01-11
• Primary Completion: 2020-12
• Status Verified: 2023-03
• Study Completion: 2023-10
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 412

Inclusion Criteria

• ages of 18 and 85
• a midshaft clavicle fracture
• fracture displaced the width of the clavicle or shortened at least 1.5 cm
• less than 21 days since the injury

Exclusion Criteria

• injury involving the lateral ligaments
• fracture involve the sternoclavicular joint
• Pathologic Fracture
• Open Fracture
• Fracture with neurovascular compromise
• Displaced fracture with impending skin compromise
• Medical comorbidities that preclude surgery
• Associated injuries to ipsilateral shoulder girdle
• severe cognitive disability or injury that may inhibit study form completion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ORIF	ORIF with Plate and Screws	Open Reduction and Internal Fixation (ORIF) with Plate and Screws
Pin	Pin Fixation	Pin Fixation

Primary Outcome Measures

Name	Time	Method
Disability of Arm, Shoulder and Hand (DASH) scores	1 year	Disability of Arm, Shoulder and Hand (DASH) scores

Secondary Outcome Measures

Name	Time	Method
Reoperation rate	1 year	rate of reoperations between groups

Trial Locations

Locations (1)

Prisma Health; 🇺🇸 Greenville, South Carolina, United States