title: 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®.
abstract: Proximal 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.
  
  
  
  Forty 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.
  
  
  
  Because 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.
  
  
  
  Clinical Trial ( NCT02609906 ), November 18, 2015, registered retrospectively.
authors: Department of Trauma Surgery, Ludwig-Maximilians-University (LMU), Campus Innenstadt, Nußbaumstr. 20, D-80336, Munich, Germany. tobias.helfen@med.uni-muenchen.de.
authors: Tobias
authors: T
authors: Helfen
authors: Department of Trauma Surgery, Ludwig-Maximilians-University (LMU), Campus Innenstadt, Nußbaumstr. 20, D-80336, Munich, Germany.
authors: Georg
authors: G
authors: Siebenbürger
authors: Department of Trauma Surgery, Ludwig-Maximilians-University (LMU), Campus Innenstadt, Nußbaumstr. 20, D-80336, Munich, Germany.
authors: Marcel
authors: M
authors: Mayer
authors: Department of Trauma Surgery, Ludwig-Maximilians-University (LMU), Campus Innenstadt, Nußbaumstr. 20, D-80336, Munich, Germany.
authors: Wolfgang
authors: W
authors: Böcker
authors: Department of Trauma Surgery, Ludwig-Maximilians-University (LMU), Campus Innenstadt, Nußbaumstr. 20, D-80336, Munich, Germany.
authors: Ben
authors: B
authors: Ockert
authors: Department of Trauma Surgery, Ludwig-Maximilians-University (LMU), Campus Innenstadt, Nußbaumstr. 20, D-80336, Munich, Germany.
authors: Florian
authors: F
authors: Haasters
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001843:Bone Cements / Q000009:adverse effects / Q000627:therapeutic use*; D001858:Bone Nails / Q000009:adverse effects*; D001860:Bone Plates / Q000009:adverse effects*; D001863:Bone Screws; D005260:Female; D005594:Fracture Fixation, Intramedullary / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D015994:Incidence; D007431:Intraoperative Complications / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D017698:Postmenopause; D011183:Postoperative Complications / Q000453:epidemiology; D011859:Radiography; D016059:Range of Motion, Articular; D012086:Reoperation / Q000706:statistics & numerical data; D012784:Shoulder Fractures / Q000453:epidemiology / Q000601:surgery*; D016896:Treatment Outcome
chemical_list: D001843:Bone Cements
keywords: Humeral head; Nail; Osteoporosis; Osteosynthesis; Plate