Cement augmentation of the proximal humerus internal locking system in elderly patients: a multicenter randomized controlled trial

Archives of Orthopaedic and Trauma Surgery
Clemens HenggFranz Kralinger

Abstract

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. 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. 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 g...Continue Reading

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Citations

Aug 12, 2020·European Journal of Trauma and Emergency Surgery : Official Publication of the European Trauma Society·Till BerkFlorin Allemann
Dec 9, 2020·Journal of Biomechanics·Luca CristofoliniEnrico Guerra
Feb 2, 2021·Journal of the Mechanical Behavior of Biomedical Materials·Vasiliki C PanagiotopoulouPeter Varga
Jun 1, 2021·European Journal of Trauma and Emergency Surgery : Official Publication of the European Trauma Society·Peter William KyriakidesPhilipp Leucht

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NCT01847508

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CONSORT
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