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

16:58 EDT 20th April 2014 | BioPortfolio

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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

High Energy Midshaft Clavicle Fractures

Intervention

ORIF with Plate and Screws, Pin Fixation

Location

Greenville Hospital System Univeristy Medical Center
Greenville
South Carolina
United States
29605

Status

Enrolling by invitation

Source

Greenville Hospital System University Medical Center

Results (where available)

View Results

Links

Medical and Biotech [MESH] Definitions

A method of producing a high-quality scan by digitizing and subtracting the images produced by high- and low-energy x-rays.

Implantable fracture fixation devices attached to bone fragments with screws to bridge the fracture gap and shield the fracture site from stress as bone heals. (UMDNS, 1999)

The region in the dorsal ECTODERM of a chordate embryo that gives rise to the future CENTRAL NERVOUS SYSTEM. Tissue in the neural plate is called the neuroectoderm, often used as a synonym of neural plate.

Devices used to hold tissue structures together for repair, reconstruction or to close wounds. They may consist of adsorbable or non-adsorbable, natural or synthetic materials. They include tissue adhesives, skin tape, sutures, buttons, staples, clips, screws, etc., each designed to conform to various tissue geometries.

Electron transfer through the cytochrome system liberating free energy which is transformed into high-energy phosphate bonds.

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