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®

BMC Musculoskelet Disord. 2016 Oct 28;17(1):448. doi: 10.1186/s12891-016-1302-6.

Abstract

Background: 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.

Methods/design: 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.

Discussion: 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.

Trial registration: Clinical Trial ( NCT02609906 ), November 18, 2015, registered retrospectively.

Keywords: Humeral head; Nail; Osteoporosis; Osteosynthesis; Plate.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Bone Cements / adverse effects
  • Bone Cements / therapeutic use*
  • Bone Nails / adverse effects*
  • Bone Plates / adverse effects*
  • Bone Screws
  • Female
  • Fracture Fixation, Intramedullary / adverse effects
  • Fracture Fixation, Intramedullary / instrumentation*
  • Fracture Fixation, Intramedullary / methods
  • Humans
  • Incidence
  • Intraoperative Complications / epidemiology
  • Male
  • Middle Aged
  • Patient Satisfaction
  • Postmenopause
  • Postoperative Complications / epidemiology
  • Radiography
  • Range of Motion, Articular
  • Reoperation / statistics & numerical data
  • Shoulder Fractures / epidemiology
  • Shoulder Fractures / surgery*
  • Treatment Outcome

Substances

  • Bone Cements

Associated data

  • ClinicalTrials.gov/NCT02609906