Prisma Health
Greenville, South Carolina, 29605, United States
NCT Number: NCT00590850
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).
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Greenville, South Carolina, 29605, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ORIF with plate and screws
Clavicle fixation with clavicle pin
Time frame: 1 year
Disability of Arm, Shoulder and Hand (DASH) scores
Time frame: 1 year
rate of reoperations between groups
Prisma Health-Upstate
Other
A Multicenter, Prospective, Randomized Trial of Non-Operative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures
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