| BMC Musculoskeletal Disorders | |
| Operative treatment of 2-part surgical neck fractures of the proximal humerus (AO 11-A3) in the elderly: Cement augmented locking plate Philos™ vs. proximal humerus nail MultiLoc® | |
| Study Protocol | |
| Georg Siebenbürger1  Tobias Helfen1  Marcel Mayer1  Florian Haasters1  Wolfgang Böcker1  Ben Ockert1  | |
| [1] Department of Trauma Surgery, Ludwig-Maximilians-University (LMU), Campus Innenstadt, Nußbaumstr. 20, D-80336, Munich, Germany; | |
| 关键词: Humeral head; Osteosynthesis; Plate; Nail; Osteoporosis; | |
| DOI : 10.1186/s12891-016-1302-6 | |
| received in 2015-12-17, accepted in 2016-10-17, 发布年份 2016 | |
| 来源: Springer | |
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【 摘 要 】
BackgroundProximal humeral fractures are with an incidence of 4–5 % the third most common fractures in the elderly. In 20 % of humeral fractures there is an indication for surgical treatment according to the modified Neer-Criteria. A secondary varus dislocation of the head fragment and cutting-out are the most common complications of angle stable locking plates in AO11-A3 fractures of the elderly. One possibility to increase the stability of the screw-bone-interface is the cement augmentation of the screw tips. A second is the use of a multiplanar angle stablentramedullary nail that might provide better biomechanical properties after fixation of 2-part-fractures. A comparison of these two treatment options augmented locking plate versus multiplanar angle stable locking nail in 2-part surgical neck fractures of the proximal humerus has not been carried out up to now.Methods/DesignForty patients (female/male, ≥60 years or female postmenopausal) with a 2-part-fracture of the proximal humerus (AO type 11-A3) will be randomized to either to augmented plate fixation group (PhilosAugment) or to multiplanar intramedullary nail group (MultiLoc). Outcome parameters are Disabilities of the Shoulder, Arm and Hand-Score (DASH) Constant Score (CS), American Shoulder and Elbow Score (ASES), Oxford Shoulder Score (OSS), Range of motion (ROM) and Short Form 36 (SF-36) after 3 weeks, 6 weeks, 3 months, 6 months, 12 and 24 months.DiscussionBecause of the lack of clinical studies that compare cement augmented locking plates with multiplanar humeral nail systems after 2-part surgical neck fractures of the proximal humerus, the decision of surgical method currently depends only on surgeons preference. Because only a randomized clinical trial (RCT) can sufficiently answer the question if one treatment option provides advantages compared to the other method we are planning to perform a RCT.Trial registrationClinical Trial (NCT02609906), November 18, 2015, registered retrospectively.
【 授权许可】
CC BY
© The Author(s). 2016
【 预 览 】
| Files | Size | Format | View |
|---|---|---|---|
| RO202311094926898ZK.pdf | 545KB |
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