Phase
Condition
N/ATreatment
Clavicle open reduction and internal fixation
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient must be 18 years of age or older.
Patient must have a clavicle fracture requiring surgical intervention and beeligible for fixation by locking plate and screws.
Unilateral or Bilateral fractures.
Patient must be capable of understanding the doctor's explanation, followingdoctor's instruction, is able to and willing to complete the protocol requiredfollow-up.
Patient must have a signed IRB/EC approved informed consent.
Exclusion
Exclusion Criteria:
Active infection.
Patients presenting conditions including blood supply limitations, insufficientquantity or quality of bone.
Patients with mental or neurologic conditions who are unwilling or incapable ofgiving proper informed consent, following postoperative care instructions.
Foreign body sensitivity where material sensitivity is suspected, testing is to becompleted prior to implantation of the device.
Patient is a current alcohol or drug abuser
Patient is a prisoner
Patient known to be pregnant or breast feeding
Likely problems with maintaining follow-up program (e.g. patient with no fixedaddress, long distance, plans to move during course of study)
Not expected to survive the duration of the follow-up program
Study Design
Study Description
Connect with a study center
General Foundation of the University of Valladolid
Valladolid, 47002
SpainSite Not Available
Cleveland Clinic Florida
Weston, Florida 33331
United StatesSite Not Available
University of Michigan - Michigan Medicine
Ann Arbor, Michigan 48137
United StatesSite Not Available
Slocum Research & Education Foundation
Eugene, Oregon 97401
United StatesSite Not Available
University of Texas San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
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