NCT02075476.
Study name | Prospective, randomized and double blind study of parallel groups for evaluating the effectiveness between two surgical techniques for reconstruction of humeral proximal extremity fractures or fractures luxation in three or four fragments of Neer's classification |
Methods | Randomised controlled trial |
Participants | 40 participants, aged 70 years or over, with "humeral proximal extremity fracture or fracture luxation in three or four fragments of Neer's classification" |
Interventions | 1. Reverse arthroplasty Delta Xtent (DePuy) 2. Hemiarthroplasty Global Fx (DePuy) |
Outcomes | Follow‐up: 1, 3, 6, 12, 18 and 24 months Primary outcome: ASES (American Shoulder and Elbow Surgeons) score Secondary outcomes: intraoperative complications; postoperative complications, surgical time, recovery time |
Starting date | May 2013 Estimated completed date: May 2016 (actually completed 6 August 2019) |
Contact information | Carlos Alvarez, MD Hospital General Universitario Gregorio Marañon Madrid, Spain, 28007 Email: calvargon@gmail.com |
Notes | Verified as recruiting participants in March 2014 by Hospital General Universitario Gregorio Marañon Verified as completed as posted 7 August 2019 Top‐up search conducted in November 2021 identified updated trial registration with results posted (Z‐TUp Alvarez 2020) |