Proximal humeral fractures occur frequently, with fixed angle locking plates often being used for their treatment. However, the failure rate of this fixation is high, ranging between 10 and 35%. Numerous variables are thought to affect the performance of the fixation used, including the length and configuration of screws used and the plate position. However, there is currently limited quantitative evidence to support concepts for optimal fixation. The variations in surgical techniques and human anatomy make biomechanical testing prohibitive for such investigations. Therefore, a finite element osteosynthesis test kit has been developed and validated - SystemFix. The aim of this study was to quantify the effect of variations in screw length, configuration and plate position on predicted failure risk of PHILOS plate fixation for unstable proximal humerus fractures using the test kit. Twenty-six low-density humerus models were selected and osteotomized to create a malreduced unstable three-part fracture AO/OTA 11-B3.2 with medial comminution which was virtually fixed with the PHILOS plate. In turn, four different screw lengths, twelve different screw configurations and five plate positions were simulated. Each time, three physiological loading cases were modelled, with an established finite element analysis methodology utilized to evaluate average peri-screw bone strain, this measure has been previously demonstrated to predict experimental fatigue fixation failure. All three core variables lead to significant differences in peri-screw strain magnitudes, i.e. predicted failure risk. With screw length, shortening of 4 mm in all screw lengths (the distance of the screw tips to the joint surface increasing from 4 mm to 8 mm) significantly (p < 0 .001) increased the risk of failure. In the lowest density bone, every additional screw reduced failure risk compared to the four-screw construct, whereas in more dense bone, once the sixth screw was inserted, no further significant benefit was seen (p=0.40). Screw configurations not including
Treatment of proximal humerus fractures (PHF) is controversial in many respects, including the choice of surgical approach for fixation when using a locking plate. The classic deltopectoral (DP) approach is believed to increase the risk of avascular necrosis while making access to the greater tuberosity more difficult. The deltoid split (DS) approach was developed to respect minimally invasive surgery principles. The purpose of the present study (NCT-00612391) was to compare outcomes of PHF treated by DP and DS approaches in terms of function (Q-DASH, Constant score), quality of life (SF12), and complications in a prospective randomized multicenter study. From 2007 to 2016, all patients meeting the inclusion/exclusion criteria in two University Trauma Centers were invited to participate in the study. Inclusion criteria were: PHF Neer II/III, isolated injury, skeletal maturity, speaking French or English, available for follow-up (FU), and ability to fill questionnaires. Exclusion criteria: Pre-existing pathology to the limb, patient-refusing or too ill to undergo surgery, patient needing another type of treatment (nail, arthroplasty), axillary nerve impairment, open fracture. After consent, patients were randomized to one of the two treatments using the dark envelope method. Pre-injury status was documented by questionnaires (SF12, Q-DASH, Constant score). Range of motion was assessed. Patients were followed at two weeks, six weeks, 3-6-12-18-24 months. Power calculation was done with primary outcome: Q-DASH. A total of 92 patients were randomised in the study and 83 patients were followed for a minimum of 12 months. The mean age was 62 y.o. (+- 14 y.) and 77% were females. There was an equivalent number of Neer II and III, 53% and 47% respectively. Mean FU was of 26 months. Forty-four patients were randomized to the DS and 39 to the DP approach. Groups were equivalent in terms of age, gender, BMI, severity of fracture and pre-injury scores. All clinical outcome measures were in favor of the deltopectoral approach. Primary outcome measure, Q-DASH, was better statistically and clinically in the DP group (12 vs 26, p=0,003). Patients with DP had less pain and better quality of life scores than with DS (VAS 1/10 vs 2/10 p=0,019 and SF12M 56 vs 51, p=0,049, respectively). Constant-Murley score was higher in the DP group (73 vs 60, p=0,014). However, active external rotation was better with the DS approach (45° vs 35°). There were more complications in DS patients, with four screw cut-outs vs zero, four avascular necrosis vs one, and five reoperations vs two.
