The purpose of this study was to develop a quality appraisal tool for the assessment of laboratory basic science biomechanical studies.

Materials andScore development comprised of the following phases: item identification/development, item reduction, content/face/criterion validity, weighting, test-retest reliability and internal consistency. For item identification/development, the panel was asked to independently list criteria and factors they considered important for cadaver study and generate items that should be used to appraise cadaver study quality. For content validity, the content validity ratio (CVR) was calculated. The minimum accepted content validity index (CVI) was set to 0.85. For weighting, equal weight for each item was 6.7% [15 items]. Based on these figures the panel was asked to either upscale or downscale the weight for each item ensuring that the final sum for all items was 100%. Face validity was assessed by each panel member using a Likert scale from 1–7. Strong face validity was defined as a mean score of >5. Test-retest reliability was assessed using 10 randomly selected studies. Criterion validity was assessed using the QUACS scale as standard. Internal consistency was assessed using Cronbach's alpha.

Five items reached a CVI of 1 and 10 items a CVI of 0.875. For weighting five items reached a final weight of 10% and ten items 5%. The mean score for face validity was 5.6. Test-retest reliability ranged from 0.78–1.00 with 9 items reaching a perfect score. Criterion validity was 0.76 and considered to be strong. Cronbach's alpha was calculated to be 0.71 indicating acceptable internal consistency.

The new proposed quality score for basic science studies consists of 15 items and has been shown to be reliable, valid and of acceptable internal consistency. It is suggested that this score should be utilised when assessing basic science studies.

Nearly a quarter of screws cause damage during insertion by stripping the bone, reducing pullout strength by over 80%. Studies assessing surgically achieved tightness have predominately shown that variations between individual surgeons can lead to underpowered investigations. Further to the variables that have been previously explored, several basic aspects related to tightening screws have not been evaluated with regards to how they affect screw insertion. This study aims to identify the achieved tightness for several variables, firstly to better understand factors related to achieving optimal intraoperative screw purchase and secondly to establish improved methodologies for future studies.

Two torque screwdrivers were used consecutively by two orthopaedic surgeons to insert 60 cortical, non-locking, stainless-steel screws of 3.5 mm diameter through a 3.5 mm plate, into custom-made 4 mm thick 20 PCF sheets of Sawbone, mounted on a custom-made jig. Screws were inserted to optimal tightness subjectively chosen by each surgeon. The jig was attached to a bench for vertical screw insertion, before a further 60 screws were inserted using the first torque screwdriver with the jig mounted vertically, enabling horizontal screw insertion. Following the decision to use the first screwdriver to insert the remaining screws in the vertical position for the other variables, the following test parameters were assessed with 60 screws inserted per surgeon: without gloves, double surgical gloves, single surgical gloves, non-sterile nitrile gloves and, with and then without augmented feedback (using digitally displayed real-time achieved torque). For all tests, except when augmented feedback was used, the surgeon was blinded to the insertion torque. Once the stopping torque was reached, screws were tightened until the stripping torque was found, this being used to calculate tightness (stopping/stripping torque ratio). Screws were recorded to have stripped the material if the stopping torque was greater than the stripping torque. Following tests of normality, Mann-Whitney-U comparisons were performed between and combining both surgeons for each variable, with Bonferroni corrections for multiple comparisons.

There was no significant (p=0.29) difference in the achieved tightness between different torque screw drivers nor different jig positions (p=0.53). The use of any gloves led to significant (p < 0 .001) increases in achieved tightness compared to not using gloves for one surgeon but made no difference for the other (p=0.38–0.74). Using augmented feedback was found to virtually eliminate stripping. For one surgeon average tightness increased significantly (p < 0 .001) when torque values were displayed from 55 to 75%, whilst for the other, this was associated with significantly decreases (p < 0 .001), 72 to 57%, both surgeons returned to their pre-augmentation tightness when it was removed.

Individual techniques make a considerable difference to the impact from some variables involved when inserting screws. However, the orientation of screws insertion and the type of screwdriver did not affect achieved screw tightness. Using visual feedback reduces rates of stripping and investigating ways to incorporate this into clinical use are recommended. Further work is underway into the effect of other variables such as bone density and cortical thickness.

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 calcar screws, also demonstrated significant (p < 0 .001) increased risk of failure. Finally, more proximal plate positioning, compared to the suggested operative technique, was associated with reduced the predicted failure risk, especially in constructs using calcar screws, and distal positioning increased failure risk.

Optimal fixation constructs were found when placing screws 4 mm from the joint surface, in configurations including calcar screws, in plates located more proximally, as these factors were associated with the greatest reduction in predicted fixation failure in 3-part unstable proximal humeral fractures. These results may help to provide practical recommendations on the implant usage for improved primary implant stability and may lead to better healing outcomes for osteoporotic proximal fracture patients. Whilst prospective clinical confirmation is required, using this validated computational tool kit enables the discovery of findings otherwise hidden by the variation and prohibitive costs of appropriately powered biomechanical studies using human samples.

Distal radius fractures have an incidence rate of 17.5% among all fractures. Their treatment in case of comminution, commonly managed by volar locking plates, is still challenging. Variable-angle screw technology could counteract these challenges. Additionally, combined volar and dorsal plate fixation is valuable for treatment of complex fractures at the distal radius. Currently, biomechanical investigation of the competency of supplemental dorsal plating is scant. The aim of this study was to investigate the biomechanical competency of double-plated distal radius fractures in comparison to volar locking plate fixation.

Complex intra-articular distal radius fractures AO/OTA 23-C 2.1 and C 3.1 were created by means of osteotomies, simulating dorsal defect with comminution of the lunate facet in 30 artificial radii, assigned to 3 study groups with 10 specimens in each. The styloid process of each radius was separated from the shaft and the other articular fragments. In group 1, the lunate facet was divided to 3 equally-sized fragments. In contrast, the lunate in group 2 was split in a smaller dorsal and a larger volar fragment, whereas in group 3 was divided in 2 equal fragments. Following fracture reduction, each specimen was first instrumented with a volar locking plate and non-destructive quasi-static biomechanical testing under axial loading was performed in specimen's inclination of 40° flexion, 40° extension and 0° neutral position. Mediolateral radiographs were taken under 100 N loads in flexion and extension, as well as under 150 N loads in neutral position. Subsequently, all biomechanical tests were repeated after supplemental dorsal locking plate fixation of all specimens. Based on machine and radiographic data, stiffness and angular displacement between the shaft and lunate facet were determined.

Stiffness in neutral position (N/mm) without/with dorsal plating was on average 164.3/166, 158.5/222.5 and 181.5/207.6 in groups 1–3. It increased significantly after supplementary dorsal plating in groups 2 and 3.

Predominantly, from biomechanical perspective supplemental dorsal locked plating increases fixation stability of unstable distal radius fractures after volar locked plating. However, its effect depends on the fracture pattern at the distal radius.