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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.

SUBMITTER: Hengg C

PROVIDER: S-EPMC6570671 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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

Hengg Clemens C Nijs Stefaan S Klopfer Tim T Jaeger Martin M Platz Andreas A Pohlemann Tim T Babst Reto R Franke Jochen J Kralinger Franz F

Archives of orthopaedic and trauma surgery 20190225 7

<h4>Introduction</h4>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.<h4>Materials ...[more]

PMID: 30805708

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Project description:BackgroundAlthough increasingly used, the benefit of surgical treatment of displaced 2-part proximal humerus fractures has not been proven. This trial evaluates the clinical effectiveness of surgery with locking plate compared with non-operative treatment for these fractures.Methods and findingsThe NITEP group conducted a superiority, assessor-blinded, multicenter randomized trial in 6 hospitals in Finland, Estonia, Sweden, and Denmark. Eighty-eight patients aged 60 years or older with displaced (more than 1 cm or 45 degrees) 2-part surgical or anatomical neck proximal humerus fracture were randomly assigned in a 1:1 ratio to undergo either operative treatment with a locking plate or non-operative treatment. The mean age of patients was 72 years in the non-operative group and 73 years in the operative group, with a female sex distribution of 95% and 87%, respectively. Patients were recruited between February 2011 and April 2016. The primary outcome measure was Disabilities of Arm, Shoulder, and Hand (DASH) score at 2-year follow-up. Secondary outcomes included Constant-Murley score, the visual analogue scale for pain, the quality of life questionnaire 15D, EuroQol Group's 5-dimension self-reported questionnaire EQ-5D, the Oxford Shoulder Score, and complications. The mean DASH score (0 best, 100 worst) at 2 years was 18.5 points for the operative treatment group and 17.4 points for the non-operative group (mean difference 1.1 [95% CI -7.8 to 9.4], p = 0.81). At 2 years, there were no statistically or clinically significant between-group differences in any of the outcome measures. All 3 complications resulting in secondary surgery occurred in the operative group. The lack of blinding in patient-reported outcome assessment is a limitation of the study. Our assessor physiotherapists were, however, blinded.ConclusionsThis trial found no significant difference in clinical outcomes at 2 years between surgery and non-operative treatment in patients 60 years of age or older with displaced 2-part fractures of the proximal humerus. These results suggest that the current practice of performing surgery on the majority of displaced proximal 2-part fractures of the humerus in older adults may not be beneficial.Trial registrationClinicalTrials.gov NCT01246167.

Project description:BACKGROUND:Proximal humerus fractures are the third most common fracture in the elderly population and are expected to increase due to the aging population. Surgical fixation with locking plate technology has increased over the last decade despite a lack of proven superiority in the literature. Three previous randomized controlled trials have not shown a difference in patient-centered outcomes when comparing non-operative treatment with open reduction and internal fixation. Low patient enrollment and other methodological concerns however limit the generalizability of these conclusions and as a result, management of these fractures remains a controversy. By comparing the functional outcomes of locked plate surgical fixation versus non-operative treatment of displaced three and four-part proximal humerus fractures in the elderly population with a large scale, prospective, multi-centered randomized controlled trial, the optimal management strategy for this common injury may be determined. METHODS:We will conduct a prospective, single blind randomized controlled parallel arm trial to compare non-operative management of proximal humerus fractures with open reduction and internal fixation using locked plating technology. One-hundred and sixty patients > age 60 with acute 3- or 4- part proximal humerus fractures will be randomized to either open reduction and internal fixation with locked plating technology or non-operative management treatment arms. The primary outcome measure is the Constant Score at 24 months post-operative. Secondary outcome measures include the American Shoulder and Elbow Surgeon's Score (ASES), EuroQol EQ-5D-5 L Health Questionnaire Score, short form PROMIS upper extremity score and IPAQ for the elderly score. Further outcome measures include assessment of the initial classification, displacement and angulation and the quality of surgical reduction via a standard computed tomography (CT) scan; rates of non-union, malunion, arthrosis, osteopenia or other complications including infection, nerve injury, intra-articular screw penetration, reoperation rates and hospital re-admission rates. DISCUSSION:The results of this trial will provide Level 1 evidence to guide decision-making in the treatment of proximal humerus fractures in the elderly population. TRIAL REGISTRATION:ClinicalTrials.gov NCT02362100 . Registered 5 Feb 2015.

Project description:Joint-preserving surgical treatment of complex unstable proximal humerus fractures remains challenging, with high failure rates even following state-of-the-art locked plating. Enhancement of implants could help improve outcomes. By overcoming limitations of conventional biomechanical testing, finite element (FE) analysis enables design optimization but requires stringent validation. This study aimed to computationally enhance the design of an existing locking plate to provide superior fixation stability and evaluate the benefit experimentally in a matched-pair fashion. Further aims were the evaluation of instrumentation accuracy and its potential influence on the specimen-specific predictive ability of FE. Screw trajectories of an existing commercial plate were adjusted to reduce the predicted cyclic cut-out failure risk and define the enhanced (EH) implant design based on results of a previous parametric FE study using 19 left proximal humerus models (Set A). Superiority of EH versus the original (OG) design was tested using nine pairs of human proximal humeri (N = 18, Set B). Specimen-specific CT-based virtual preoperative planning defined osteotomies replicating a complex 3-part fracture and fixation with a locking plate using six screws. Bone specimens were prepared, osteotomized and instrumented according to the preoperative plan via a standardized procedure utilizing 3D-printed guides. Cut-out failure of OG and EH implant designs was compared in paired groups with both FE analysis and cyclic biomechanical testing. The computationally enhanced implant configuration achieved significantly more cycles to cut-out failure compared to the standard OG design (p < 0.01), confirming the significantly lower peri-implant bone strain predicted by FE for the EH versus OG groups (p < 0.001). The magnitude of instrumentation inaccuracies was small but had a significant effect on the predicted failure risk (p < 0.01). The sample-specific FE predictions strongly correlated with the experimental results (R2 = 0.70) when incorporating instrumentation inaccuracies. These findings demonstrate the power and validity of FE simulations in improving implant designs towards superior fixation stability of proximal humerus fractures. Computational optimization could be performed involving further implant features and help decrease failure rates. The results underline the importance of accurate surgical execution of implant fixations and the need for high consistency in validation studies.

Project description:PurposeTo investigate the clinical outcomes following the arthroscopic removal of proximal humerus locking plates for symptomatic hardware after open reduction and internal fixation (ORIF) of proximal humerus fractures.MethodsPatients who underwent arthroscopic removal of hardware (ROH) with capsular release due to pain and/or immobility after receiving locking plates to treat proximal humerus fractures from 2009 to 2016 were identified. Operative and clinic records were reviewed to obtain demographic information, concomitant procedures during ROH, and pre- and postoperative active shoulder range of motion. Postoperative patient-reported outcomes included the QuickDASH, PROMIS Pain Intensity, Constant, and University of California, Los Angeles shoulder rating scale.ResultsIn total, 88 patients were included. Patients were evaluated at a minimum of 6 weeks postoperatively after ROH. Patients with pre- and postoperative active range of motion values demonstrated significant improvements in mean forward elevation (n = 69; 78.4%; 115.1° to 152.1°, P < .001), abduction (n = 29; 33.0%; 70.9° to 138.7°, P < .001), external rotation (n = 49; 55.7%; 43.7° to 58.6°, P = .012), and internal rotation (n = 45; 51.1%; 25.7° to 61.9°, P < .001). Patients also reported positive patient-reported scores, including the QuickDASH (4.1 ± 7.8), PROMIS Pain Intensity (3.5 ± 0.9), Constant (84.6 ± 10.7), and University of California, Los Angeles shoulder rating scale (33 ± 2.9), which were measured 70.6 ± 26.6 months postoperatively. There were no surgical complications, no arthroscopic cases were converted to open, but 2 reported refractures (2.3%).ConclusionsArthroscopic-assisted removal of proximal humerus locking plates significantly improves motion and function while allowing for management of concomitant shoulder pathology and potentially avoiding open surgery complications. Given that patients undergoing this procedure frequently have multiple comorbidities, arthroscopic-assisted removal with smaller incisions may minimize risks while restoring shoulder mobility. Therefore, arthroscopic ROH for patients experiencing symptomatic hardware after ORIF is recommended.Level of evidenceLevel IV, therapeutic case series.

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

Publications

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

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