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Randomized Controlled Trial
Operative treatment of 2-part surgical neck type fractures of the proximal humerus in the elderly: Cement augmented locking plate PHILOS™ vs. proximal humerus nail multiloc®.
- Tobias Helfen, Georg Siebenbürger, Evi Fleischhacker, Johannes Gleich, Wolfgang Böcker, and Ben Ockert.
- Department of General, Trauma and Reconstructive Surgery, University Hospital, LMU Munich, Germany. Electronic address: tobias.helfen@med.uni-muenchen.de.
- Injury. 2020 Oct 1; 51 (10): 2245-2252.
IntroductionThe purpose of this prospective randomized controlled clinical trial was to compare locked plating with intramedullary nailing in the treatment of displaced 2-part surgical neck type proximal humeral fractures in elderly patients.Patients And MethodsPatients ≥60 years of age with a displaced 2-part surgical neck type fracture of the proximal humerus were surgically treated and randomized for either augmented locking plate fixation Group LP or multiplanar intramedullary nailing Group IN. The primary outcome parameter was the Disabilities of the Shoulder, Arm and Hand (DASH) Score after 24 months. Secondary outcome parameters were the age- and gender adjusted Constant Murley Score (CS), the American Shoulder and Elbow Score (ASES), the Oxford Shoulder Score (OSS) and the Short Form 36 (SF-36) after 6 weeks, 3 months, 6 months, 12 and 24 months. Further parameters included the quality of fracture reduction as well as complications and revision surgeries. 60 patients with a mean age of 75±9.8 were included and longitudinally followed over 24 months (follow-up rate: 83.3%).ResultsThe mean DASH-Scores at 24 months was 32.6 ± 9.7 points in Group LP versus 37.8 ± 8.3 points in Group IN (p = 0.04). The mean Constant Murley Score at 24 months follow-up was 76.2 ± 7.7 points in Group LP compared to 72 ± 9.1 points in Group IN (p = 0.08). The ASES at 24 months follow-up was 75.1 ± 9 points in Group LP versus to 73.5 ± 8.9 in Group IN (p = 0.51). The OSS at 24 months was 43.7 ± 8.1 in Group LP compared to 38.2 ± 10 in Group IN (p = 0.03). The SF-36 at 24 months was 74.7 ± 12.5 in Group LP versus to 70.9 ± 12.8 in Group IN (p = 0.29). Screw cutting out was observed in n = 2 (6,7%) cases of Group LP, and in none of Group IN (p = 0.49). Revision surgery was necessary in n = 2 (6.7%) cases of Group LP and in two cases of Group IN (6.7%, p = 1).ConclusionFunctional outcomes are similar at 2-years follow-up in locked plating with screw tip augmentation compared to intramedullary nailing. Both implants reached low complication- and revision rates for two-part surgical neck types fractures of the proximal humerus in patients ≥60 years, if anatomic fracture reduction and accurate implant position was obtained.Copyright © 2020. Published by Elsevier Ltd.
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