Orthop Traumatol Sur
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Patient safety requires speedy detection of any medical device malfunction; this is known as "materials vigilance". It entails the need to be able to trace back the life-long pathway of a device; this is "traceability". European regulations enact free circulation of medical devices throughout the European Union, with each member state being responsible for safety within its own territory. ⋯ A change in the organization of traceability is presently underway, in the form of international Unique Device Identifiers, with harmonized label data, barcodes and standardized terminology. A European and later international database will be set up. The objective is to make Unique Device Identifiers mandatory within the EU by 2017.
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Orthop Traumatol Sur · Feb 2016
Multicenter StudyReconstruction plates for midshaft clavicular fractures: A retrospective cohort study.
For the fixation of displaced midshaft clavicular fractures different plates are available, each with its specific pros and cons. The ideal plating choice for this lesion remains subject to ongoing discussion. Reconstruction plates are cheap and easily bendable, but their strength and stability have been questioned. The aim of this study was to evaluate the failure rate of reconstruction plates in the fixation of clavicular fractures. ⋯ Level IV. Retrospective study.
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Orthop Traumatol Sur · Feb 2016
Multicenter StudyAcute 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 plate is present involves functional limitations, pain and a risk factor for the development of hardware-related-injuries. Arthroscopy-assisted procedures compared to open-metal hardware techniques offer: less morbidity, the possibility to treat associated lesions and no need for a second operation. The aim was to compare the Quality of life (QoL) of patients with acute high-grade ACJ injuries (Rockwood grade III-V), managed arthroscopically with a non-rigid coracoclavicular (CC) fixation versus the QoL of patients managed with a hook plate, 24 months or more after their shoulder injury. ⋯ Level IV therapeutic; retrospective comparative study.