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

Prisma Health-Upstate

Status: Completed

Conditions: High Energy Midshaft Clavicle Fractures

Treatments: Procedure: ORIF with Plate and Screws; Procedure: Pin Fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT00590850

GHS-07-03-04

Details and patient eligibility

About

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).

Enrollment: 412 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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412 participants in 3 patient groups

Closed

No Intervention group

Description:

Closed Treatment

ORIF

Active Comparator group

Description:

Open Reduction and Internal Fixation (ORIF) with Plate and Screws

Treatment:

Procedure: ORIF with Plate and Screws

Pin

Active Comparator group

Description:

Pin Fixation

Treatment:

Procedure: Pin Fixation