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

2015-04-13 04:55:40 | 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: 2015-04-13T04:55:40-0400

Clinical Trials [391 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 [19404 Associated PubMed Articles listed on BioPortfolio]

Use of Self-Tapping Metal Screws for Temporary Fixation of a Resorbable Plate System in Maxillofacial Surgery.

Resorbable plate systems have been used in maxillofacial surgery to obviate the need for plate removal. However, resorbable plates and screws are very costly, and refixation with additional screws may...

Titanium Elastic Nail versus plate fixation of displaced midshaft clavicle fractures: A retrospective comparison study.

This study has two purposes: (1) to compare the clinical results between the Titanium Elastic Nail (TEN) and plate fixation of the displaced midshaft clavicle fracture; and (2) to demonstrate the rela...

Using suture and locking anatomical bridging plate to fix comminuted mid-shaft clavicle fractures with intramedullary nail assistance in reduction.

During conventional plate fixation of comminuted midshaft fracture of the clavicle, wedge-shaped fragments often need to be fixed with lag screws. A new procedure, which included intramedullary K-wire...

Interventions for Treating Displaced Midshaft Clavicular Fractures: A Bayesian Network Meta-Analysis of Randomized Controlled Trials.

Displaced midshaft clavicle fractures are frequent injuries. There are 3 treatment methods including conservative treatment, plate fixation, and intramedullary pin fixation. However, which is the best...

One-Stage External Fixation Using a Locking Plate: Experience in 116 Tibial Fractures.

The authors report the results of 1-stage external fixation using a locking plate in 116 tibial fractures (85 closed and 31 open). The patients were followed for an average of 22 months. The mean dura...

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"


Searches Linking to this Trial