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

Abstract

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.

Does cement augmentation of the screws in angular stable plating for proximal humerus fractures influence the radiological outcome: a retrospective assessment

“…The total revision rate using screw-tip augmentation in this study accounted for 16.7% and is located in the lower range of comparable, previously published data of conventional angular stable plating in PHFs, which showed revision rates from 13% up to 28% in an elderly population [ 2 , 4 , 7 , 16 , 18 ].…”

Synthetic Bone Substitutes and Mechanical Devices for the Augmentation of Osteoporotic Proximal Humeral Fractures: A Systematic Review of Clinical Studies

“…In the clinical setting, PMMA has been used to improve screw fixation in osteoporotic bone such as wrist and proximal femur fractures, in order to fill subchondral voids in tibial plateau fractures and provide structural support in metaphyseal fractures or vertebral fractures [ 4 , 47 , 48 ]. Three studies reported the results of polymethyl-methacrylate (PMMA) injectable cement for PHF augmentation [ 30 , 31 , 32 , 33 , 34 ], for a total of 96 patients with a mean age of 75.86 years (range of 64–92), with the purpose of reinforcing the screw-bone interface after plating fixation. In all the three studies, the same PMMA (Trauma Cem V; DePuySynthes, West Chester, PA, USA) was used.…”

“…More recently, Hengg et al [ 34 ], in a multicenter randomized controlled trial, enrolled 67 patients older than 65 years with displaced or unstable PHF. They compared the risk of mechanical failure during the first year after PHILOS plating without (control group, 34 patients) and with (augmented group, 33 patients) screw augmentation with PMMA.…”

“…The rate of mechanical complications, such as screw penetration, plate loosening, or loss of fracture reduction was generally lower for patients who received PMMA augmentation (ranging from 0% to 16%) [ 30 , 33 ]. However, the only RCT in the literature that was performed by Hengg et al did not report any statistically significant difference between the PMMA-augmented plate and the non-augmented plate fixation, even though both groups achieved excellent clinical results [ 34 ]. The use of PMMA as a metaphyseal void filler for PHF is not described, because PMMA cement is not resorbed and does not have osteoconductive properties.…”

Cement augmentation of calcar screws may provide the greatest reduction in predicted screw cut-out risk for proximal humerus plating based on validated parametric computational modelling

“…While we did not include row C in our analysis, this screw row of the PHILOS plate is not recommended by the surgical guide as, firstly, the tips often lie at the same level as row A, and secondly because row C screw tips often end close to fracture lines. Hengg et al 14 performed the only multicentre randomized prospective trial to date on the use of cement augmentation. However, their study was abandoned when early analysis showed the design to be underpowered based on an overestimation of failure rates seen with fixation.…”