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

2015-04-13 09:55:40 | BioPortfolio


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


High Energy Midshaft Clavicle Fractures


ORIF with Plate and Screws, Pin Fixation


Greenville Hospital System Univeristy Medical Center
South Carolina
United States


Enrolling by invitation


Greenville Hospital System University Medical Center

Results (where available)

View Results


Published on BioPortfolio: 2015-04-13T09:55:40-0400

Clinical Trials [527 Associated Clinical Trials listed on BioPortfolio]

Clinical Outcomes of the Trinica(R) Anterior Lumbar Plate: Fixed Screws vs. Variable Screws

Trinica Anterior Lumbar Plate (ALP) System is a commercially available, supplemental fusion device for use in the lumbar or sacral spine (L1-S1) to treat instability. The system provides ...

Using Alternative Implants for the Surgical Treatment of Hip Fractures (The FAITH Study)

Each year, hip fracture, an injury that can impair independence and quality of life, occurs in about 280,000 Americans and 36,000 Canadians. The annual healthcare costs associated with thi...

Outcome Study of Complex Distal Radius Fractures

The purpose of this study is to collect information about how people do after different treatments of a broken wrist to see if one treatment has better results.

A Multicenter Randomized Trial Comparing Antiglide and Lateral Plate Fixation in Ankle Fractures

The role of operative fixation of unstable, displaced lateral malleolus fractures is well-established (Mayer, Mak, and Yablon). However, the optimal type of fixation remains the subject of...

Long Term Follow up of the DVR-A Locking Plate

The surgical treatment of wrist fractures (distal radius bone) has been changed by the introduction of a new plate design, the locking plate. This results in improved fixation and stabili...

PubMed Articles [20896 Associated PubMed Articles listed on BioPortfolio]

Complications After Plate Fixation of Displaced Pediatric Midshaft Clavicle Fractures.

Operative treatment of displaced pediatric midshaft clavicle fractures has become increasingly popular, despite lack of evidence that surgical management leads to superior outcomes. Complications, suc...

Intramedullary Fixation of Clavicle Fractures: Anatomy, Indications, Advantages, and Disadvantages.

Historically, management of displaced midshaft clavicle fractures has consisted of nonsurgical treatment. However, recent literature has supported surgical repair of displaced and shortened clavicle f...

A Simple and Reliable Method of Narrowing Genioplasty Using Biodegradable Screws.

The T-osteotomy technique is widely performed to improve lower face aesthetics. During this narrowing genioplasty procedure, metal fixtures are required to rigidly fix the bone segments. Specifically,...

Operative Cost Comparison: Plating Versus Intramedullary Fixation for Clavicle Fractures.

Although clavicle fractures often heal well with nonoperative management, current literature has shown improved outcomes with operative intervention for specific fracture patterns in specific patient ...

Acute high-grade acromioclavicular joint injuries treatment: Arthroscopic non-rigid coracoclavicular fixation provides better quality of life outcomes than hook plate ORIF.

Treatment of acute high-grade acromioclavicular joint (ACJ) injuries with metal hardware alters the biomechanics of the ACJ, implying a second surgery for hardware removal. The period during which the...

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.

More From BioPortfolio on "Non-Operative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures"

Quick Search

Searches Linking to this Trial