Non-Operative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures
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).
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
Enrolling by invitation
Greenville Hospital System University Medical Center
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00590850
- Information obtained from ClinicalTrials.gov on July 15, 2010
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.
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...
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...
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.
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...
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...
Document fixation and healing of distal femur fractures stabilized by plate osteosynthesis using Far Cortical Locking (FCL) screws.
Bicondylar tibial plateau fractures result from high-energy injuries. Fractures of the tibial plateau can involve the tibial tubercle, which represents a disruption to the extensor mechanism and logic...
Femoral neck fractures are one of the most common fractures primarily the elderly, coupled with a high degree of morbidity and mortality. The treatment is applied a number of methods of internal fixat...
The aim of this study was to determine the feasibility of a mini-approach for distal radius volar plating. A 15-mm incision was made in 11 cadaver wrists. A 41 mm length and 24 mm width plate was pl...
This biomechanical study is the first to compare 3 fixation methods-bilateral fixed-angle plate, modified anterior tension wiring, and cannulated lag screws with anterior tension wiring-in multifragme...