PMID- 30805708 OWN - NLM STAT- MEDLINE DCOM- 20191025 LR - 20200225 IS - 1434-3916 (Electronic) IS - 0936-8051 (Print) IS - 0936-8051 (Linking) VI - 139 IP - 7 DP - 2019 Jul TI - Cement augmentation of the proximal humerus internal locking system in elderly patients: a multicenter randomized controlled trial. PG - 927-942 LID - 10.1007/s00402-019-03142-6 [doi] AB - INTRODUCTION: Cement augmentation of the proximal humerus internal locking system (PHILOS) screws might reduce complication rates in osteoporotic bones. This study compared the risk of mechanical failure during the first year after PHILOS treatment of proximal humerus fractures (PHF) without (control group) and with (augmented group) screw augmentation. Secondary objectives were to report shoulder functions, quality of life (QoL), adverse events (AEs), and reoperation rates. MATERIALS AND METHODS: This multicenter randomized trial enrolled patients aged >/= 65 years with displaced/unstable PHF from eight European centers. Randomization was performed during surgery through sealed opaque envelopes. Mechanical failures were assessed by two independent reviewers via radiographs, shoulder function by Quick DASH, SPADI, and Constant Murley scores, and QoL by EQ-5D. Follow-ups were planned at postoperative 6 weeks, 3, 6, and 12 months. RESULTS: The preliminary analysis of 6-week radiographs of the first 59 enrolled patients suggested a mechanical failure rate lower than expected and the difference between groups was too small to be detected by the planned sample size of 144. The trial was prematurely terminated after 67 patients had been enrolled: 34 (27 eligible) in the control group and 33 (29 eligible) in the augmented group. Follow-ups were performed as planned. Nine patients had mechanical failures and the failure rates (95% CI) were: augmented group, 16.1% (5.5; 33.7); control group, 14.8% (4.2; 33.7); the relative risk (95% CI) for the augmented group was 1.09 (0.32; 3.65) compared to the control group (p = 1.000). No statistically significant differences in shoulder function, QoL, and AEs were observed between study groups at 1 year. Nine patients (15.8%) underwent a revision. CONCLUSIONS: Due to premature termination, the study was underpowered. A larger study will be necessary to determine if cement augmentation lowers the risk of mechanical failure rate. FAU - Hengg, Clemens AU - Hengg C AD - Department for Trauma Surgery, A.o. Landeskrankenhaus - Universitatskliniken Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria. FAU - Nijs, Stefaan AU - Nijs S AD - Department of Traumatology, UZ Leuven, Herestraat 49, 3000, Leuven, Belgium. FAU - Klopfer, Tim AU - Klopfer T AD - Department for Traumatology and Reconstructive Surgery, BG Trauma Center, Eberhard Karls University Tubingen, Schnarrenbergstrasse 95, 72076, Tubingen, Germany. FAU - Jaeger, Martin AU - Jaeger M AD - Department of Orthopedics and Trauma Surgery, Medical Center-Albert-Ludwigs-University of Freiburg, Hugstetter Strasse 55, 79106, Freiburg, Germany. FAU - Platz, Andreas AU - Platz A AD - Department of Traumatology, City Hospital Triemli Zurich, Birmensdorferstrasse 497, 8063, Zurich, Switzerland. FAU - Pohlemann, Tim AU - Pohlemann T AD - Department of Trauma-, Hand- and Reconstructive Surgery, Saarland University, Kirrberger Strasse, Bldng. 57, 66421, Homburg, Germany. FAU - Babst, Reto AU - Babst R AD - Department of Orthopedics and Traumatology, Cantonal Hospital Lucerne, Spitalstrasse, 6000, Lucerne 16, Switzerland. FAU - Franke, Jochen AU - Franke J AD - Clinic for Trauma and Orthopaedic Surgery, BG Trauma Center Ludwigshafen, Ludwig-Guttmann-Strasse 13, 67071, Ludwigshafen, Germany. FAU - Kralinger, Franz AU - Kralinger F AD - Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria. franz.kralinger@meduniwien.ac.at. AD - Trauma and Sports Department, Teaching Hospital Medical University of Vienna, Wilhelminenspital, Montlearstr. 37, 1160, Vienna, Austria. franz.kralinger@meduniwien.ac.at. LA - eng GR - N/A/AO Foundation/ PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20190225 PL - Germany TA - Arch Orthop Trauma Surg JT - Archives of orthopaedic and trauma surgery JID - 9011043 RN - 0 (Bone Cements) SB - IM MH - Aged MH - Bone Cements/*therapeutic use MH - Bone Screws MH - Early Termination of Clinical Trials MH - Female MH - *Fracture Fixation, Internal/adverse effects/instrumentation/methods MH - *Fractures, Bone/diagnosis/surgery MH - Humans MH - *Humerus/diagnostic imaging/injuries/surgery MH - Male MH - *Osteoporotic Fractures/diagnosis/surgery MH - Outcome and Process Assessment, Health Care MH - *Postoperative Complications/diagnosis/etiology/physiopathology/prevention & control MH - Radiography/methods MH - Shoulder/physiopathology PMC - PMC6570671 OTO - NOTNLM OT - Augmentation OT - Multicenter randomized trial OT - Osteoporosis OT - PHILOS OT - Proximal humerus fracture OT - Proximal humerus internal locking system COIS- Franz Kralinger is a consultant with DePuySynthes but did not receive personal benefits for the current study. Tim Pohlemann was the chairman of the AO TK-System during the time of study. Martin Jaeger is a member of the AO UEEG. EDAT- 2019/02/26 06:00 MHDA- 2019/10/28 06:00 PMCR- 2019/02/25 CRDT- 2019/02/27 06:00 PHST- 2018/09/19 00:00 [received] PHST- 2019/02/26 06:00 [pubmed] PHST- 2019/10/28 06:00 [medline] PHST- 2019/02/27 06:00 [entrez] PHST- 2019/02/25 00:00 [pmc-release] AID - 10.1007/s00402-019-03142-6 [pii] AID - 3142 [pii] AID - 10.1007/s00402-019-03142-6 [doi] PST - ppublish SO - Arch Orthop Trauma Surg. 2019 Jul;139(7):927-942. doi: 10.1007/s00402-019-03142-6. Epub 2019 Feb 25.