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.

Aim

Implant-associated osteomyelitis is a devastating complication with poor outcomes following treatment, especially when caused by antibiotic-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA). A large animal model of a two-stage revision to treat MRSA implant-associated osteomyelitis has been developed to assess novel treatments. A bioresorbable, thermo-responsive hyaluronan hydrogel (THH) loaded with antibiotics has been developed and our aim was to investigate it´s in vivo efficacy as a local antibiotic carrier compared to the current standard of care i.e. antibiotic-loaded polymethylmethacrylate (PMMA) bone cement.

Aim

Non-steroidal anti-inflammatory drugs (NSAIDs) are a cornerstone of perioperative pain management in orthopedic trauma surgery, although concerns persist regarding the potential impact of these drugs on fracture healing. Furthermore, NSAIDs may also exert an influence on host immune defenses, which may also be important in the context of infection treatment. However, this has been very much under-investigated in the clinical and scientific literature. The aim of this study was to determine the impact of NSAIDs on the course of an orthopedic device-related infection (ODRI) and its response to antibiotic therapy in a rat model.

Orbital floor (OF) fractures are commonly treated by implanting either bioinert titanium or polyethylene implants, or by autologous grafts. A personalized implant made of biodegradable and osteopromotive poly(trimethylene carbonate) loaded with hydroxyapatite (PTMC-HA) could be a suitable alternative for patients where a permanent implant could be detrimental. A workflow was developed from the implant production using stereolithography (SLA) based on patient CT scan to the implantation and assessment its performance (i.e. implant stability, orbit position, bone formation) compared to personalised titanium implants in a repair OF defect sheep model. Implants fabrication was done using SLA of photo-crosslinkable PTMC mixed with HA [1–3]. Preclinical study: (sheep n=12, ethic number 34_2016) was conducted by first scanning the OF bone of each sheep in order to design and to fabricate patient specific implants (PSI) made of PTMC-HA. The fabricated PSI was implanted after creating OF defect. Bone formation and defect healing was compared to manually shaped titanium mesh using time-laps X-ray analyses, histology (Giemsa-Eosin staining) and sequential fluorochrome staining over 3-months. Additionally, the osteoinductive property of the biomaterials was assessed by intramuscular implantation (IM). In this study, we showed that the composite PTMC-HA allowed for ectopic bone formation after IM implantation, without requiring any biotherapeutics. In addition, we could repair OF defect on sheep using SLA-fabricated PTMC-HA with a good shape fidelity (compared to the virtual implant) and a better bone integration compared to the titanium mesh. This study opens the field of patient-specific implants made of degradable and osteoinductive scaffolds fabricated using additive manufacturing to replace advantageously autologous bone and titanium implants.

Introduction

The incidence of distal femoral fractures in the geriatric population is growing and represents the second most common insufficiency fracture of the femur following fractures around the hip joint. Fixation of fractures in patients with poor bone stock and early mobilisation in feeble and polymorbide patients is challenging. Development of a fixation approach for augmentation of conventional LISS (less invasive stabilization system) plating may result in superior long-term clinical outcomes and enhance safe weight bearing.

Aim

Open fractures still have a high risk for fracture-related Infection (FRI). The optimal duration of perioperative antibiotic prophylaxis (PAP) for open fractures remains controversial due to heterogeneous guidelines and highly variable prophylactic regimens in clinical practice. In order to provide further evidence with which to support the selection of antibiotic duration for open fracture care, we performed a preclinical evaluation in a contaminated rabbit fracture model.

Aim

Treatment regimens for fracture-related infection (FRI) often refer to the classification of Willenegger and Roth, which stratifies FRIs based on time of onset of symptoms. The classification includes early (<2 weeks), delayed (2–10 weeks) and late (>10 weeks) infections. Early infections are generally treated with debridement and systemic antibiotics but may not require implant removal. Delayed and late infections, in contrast, are believed to have a mature biofilm on the implant, and therefore, treatment often involves implant removal. This distinction between early and delayed infections has never been established in a controlled clinical or preclinical study. This study tested the hypothesis that early and delayed FRIs respond differently to treatment comprising implant retention.

Aim

Antibiotic prophylaxis is critical for the prevention of fracture related infection (FRI) in trauma patients, particularly those with open wounds. Administration of prophylactic antibiotics prior to arrival at the hospital (e.g. by paramedics) may reduce intraoperative bacterial load and has been recommended; however scientific evidence for pre-hospital administration is scarce.

Aim

Staphylococcus epidermidis has emerged as an important opportunistic pathogen causing orthopedic device-related infections (ODRIs). In this prospective clinical and laboratory study, we have investigated the association of genome variation and phenotypic features of the infecting S. epidermidis isolate with the clinical outcome of the infected patient.

This longitudinal microCT study revealed the osteolytic response to a Staphylococcus epidermidis-infected implant in vivoand also demonstrates how antibiotics and/or a low bone mass state influence the morphological changes in bone and the course of the infection.

Colonisation of orthopaedic implants with Staphylococcus aureusor S. epidermidisis a major clinical concern, since infection-induced osteolysis can drastically impair implant fixation or integration within bone. High fracture incidence in post-menopausal osteoporosis patients means that this patient group are at risk of implant infection. The low bone mass in these patients may exacerbate infection-induced osteolysis, or alter antibiotic efficacy. Therefore, the aims of this study were to examine the bone changes resulting from a S. epidermidisimplant infection in vivousing microCT imaging, and to determine if a low bone mass stateinfluences the course of the infection and the efficacy of antibiotic therapy. An in vivomodel system using microCT scanning [1], involving the implantation of either a sterile or a S. epidermidis-colonised PEEK screw into the proximal tibia of 24 week-old female Wistar rats, was used to investigate the morphological changes in bone following infection over a 28 day period. In addition, the efficacy of a combination antibiotic therapy (rifampin and cefazolin: administered twice daily from days 7–21 post-screw implantation) for affecting osteolysis was also assessed. A subgroup of animals was subjected to ovariectomy (OVX) at 12 weeks of age, allowing for a 12 week period for bone loss prior to screw implantation at 24 weeks. Bone resorption and formation rates, bone-implant contact and peri-implant bone volume in the proximity of the screw were assessed by microCT scanning at days 0, 3, 6, 9, 14, 20 and 28 days post-surgery. Following euthanasia at day 28, the implanted screw, bone and soft tissues were subjected to quantitative bacteriology as a measure of the efficacy of the antibiotic regimen. In non-OVX animals S. epidermidisinfection induced marked osteolysis, which peaked between 9 and 14 days post-screw implantation. Peak bone resorption was detected at day 6, before recovering to baseline levels at day 14. Infection also resulted in extensive deposition of mineralised tissue, initially within the periosteal region (day 9–14), then subsequently in the osteolytic region at day 20–28. Quantitative bacteriology indicated all non-OVX animals remained infected. Rifampin and cefazolin successfully cleared the infection in 5/6 non-OVX animals group although there was no difference observed in CT-derived bone parameters. OVX resulted in extensive loss of trabecular bone but this did not alter the temporal pattern of infection-induced osteolysis, or mineralised tissue deposition, which was similar to that observed in the non-OVX animals. Similarly, there was no difference in bacterial counts between non-OVX and OVX animals (39,005 colony-forming units (CFU) [range: 3,675–156,800] vs 37,665 CFU [range 3,250–84,000], respectively). Interestingly, antibiotic treatment was less effective in the OVX animals (3/5 remained infected), suggesting that antibiotics have reduced efficacy in OVX animals. This study demonstrates S. epidermidis-induced osteolysis displays a similar temporal pattern in both normal and low bone mass states, with comparable bacterial loads present within the localised infection site.

Aim

The aim of this study was to define the role of implant material and surface topography on infection susceptibility in a preclinical in vivo model incorporating appropriate fracture biomechanics and bone healing.

Aim

Thermal stability is a key property determining the suitability of an antibiotic agent for local application. Long-term data describing thermal stability without interference from carrier materials are scarce.

Aim

Determine the time concentration profile required to achieve vancomycin-mediated eradication of Staphylococcus aureus biofilm. This is critical for the identification of performance targets for local antibiotic delivery, yet has not been described.

Summary

An in vivo model of implant infection was developed to assess immune response. Titanium and PEEK implants were tested in the presence of an osteotomy and Staphylococcus aureus contamination. Immune response differed yet the outcome of contamination did not.

Summary Statement

In vivo microCT allows monitoring of subtle bone structure changes around infected implants in a rat model.

The common practice for insertion of distal locking screws of intramedullary (IM) nails is a freehand technique under fluoroscopic control. The process is technically demanding, time-consuming and afflicted to considerable radiation exposure to patient and surgical personnel. A new technique is introduced which guides the surgeon by landmarks on the X-ray projection.

18 fresh frozen human below-knee specimens (incl. soft tissue) were used. Each specimen was instrumented with an Expert Tibial Nail (Synthes GmbH, Switzerland) and was mounted on an OR-table. Two distal interlocking techniques were performed in random order using a Siemens ARCADIS C-arm system (Siemens AG, Munich, Germany). The newly developed guided technique, guides the surgeon by visible landmarks projected onto the fluoroscopy image. A computer program plans the drilling trajectory by 2D-3D conversion and provides said guiding landmarks for drilling in real-time. No additional tracking or navigation equipment is needed.

All four distal screws (2 mediolateral, 2 anteroposterior) were placed in each procedure. Operating time, number of taken X-rays and radiation time were recorded per procedure and for each single screw.

8 procedures were performed with the freehand technique and 10 with the guided technique. A 58% reduction in number of fluoroscopy shots per screw was found for the guided technique (7.4±3.4 vs. 17.6±10.3; p < 0.001). Total radiation time was 55% lower for the guided technique (17.1 ± 3.7s vs. 37.9 ± 9.1s) (p = 0.001). Operating time was shorter by 22% in the guided technique (3.2±1.2 min vs. 4.1±2.1 min p = 0.018).

In an experimental setting, the newly developed guided freehand technique has proven to markedly reduce radiation exposure when compared to the conventional freehand technique. The method enhances established clinical workflows and does not require cost intensive add-on devices or extensive training.

A newly developed simple navigated technique has proven to markedly reduce radiation exposure and time for distal locking of intramedullary nails.