Abstract

High tibial osteotomy (HTO) is a joint preserving alternative to knee replacement for medial tibiofemoral osteoarthritis in younger, more active patients. The procedure is technically challenging and limited also by ‘one size fits all’ plates which can result in patient discomfort necessitating plate removal.

This clinical trial evaluated A novel custom-made HTO system – TOKA (3D Metal Printing LTD, Bath, UK) for accuracy of osteotomy correction and improvements in clinical outcome scores.

The investigation was a single-arm single-centre prospective clinical trial (IRCCS Istituto Ortopedico Rizzoli; ClinicalTrials.gov NCT04574570), with recruitment of 25 patients (19M/6F; average age: 54.4 years; average BMI: 26.8), all of whom received the TOKA HTO 3D planning and surgery. All patients were predominantly diagnosed with isolated medial knee osteoarthritis and with a varus deformity under 20°. Patients were CT scanned pre- and post-operatively for 3D virtual planning and correctional assessment. All surgeries were performed by the lead clinical investigator – a consultant knee surgeon with a specialist interest in and clinical experience of HTO.

On average, Knee Society Scores (KSS) improved significantly (p<0.001) by 27.6, 31.2 and 37.2 percentage points respectively by 3-, 6- and 12-months post-surgery respectively. Other measures assessed during the study (KOOS, EQ5D) produced similar increases.

Our early experience using custom implants is extremely promising. We believe the reduced profile of the plate, as well as the reduced invasiveness and ease of surgery contributed to faster patient recovery, and improved outcome scores compared to conventional techniques. These clinical outcome results compare very favourably other case-series with published KOOS scores using different devices.

Conventional proximal tibial osteotomy is a widely successful joint-preserving treatment for osteoarthritis; however, conventional procedures do not adequately control the posterior tibial slope (PTS). Alterations to PTS can affect knee instability, ligament tensioning, knee kinematics, muscle and joint contact forces as well as range of motion.

This study primarily aimed to provide a comprehensive investigation of the variables influencing PTS during high tibial osteotomy using a 3D surgical simulation approach. Secondly, it aimed to provide a simple means of implementing the findings in future 3D pre-operative planning and /or clinically.

The influence of two key variables: the gap opening angle and the hinge axis orientation on PTS was investigated using three independent approaches: (1) 3D computational simulation using CAD software to perform virtual osteotomy surgery and simulate the post-operative outcome. (2) Derivation of a closed-form mathematical solution using a generalised vector rotation approach (3) Clinical assessment of synthetically generated x-rays of osteoarthritis patients (n=28; REC reference: 17/HRA/0033, RD&E NHS, UK) for comparison against the theoretical/computational approaches.

The results from the computational and analytical assessments agreed precisely. For three different opening angles (6°, 9° and 12°) and 7 different hinge axis orientations (from −30° to 30°), the results obtained were identical. A simple analytical solution for the change in PTS, ΔP_s, based on the hinge axis angle, α, and the osteotomy opening angle, θ, was derived:

ΔP_s=sin^-1(sin α sin θ)

The clinical assessment demonstrated that the absolute values of PTS, and changes resulting from various osteotomies, matched the results from the two relative prediction methods.

This study has demonstrated that PTS is impacted by the hinge axis angle and the extent of the osteotomy opening angle and provided computational evidence and analytical formula for general use.

High tibial osteotomy (HTO) is an effective surgical treatment for isolated medial compartment knee osteoarthritis; however, widespread adoption is limited due to difficulty in achieving the planned correction, and patient dissatisfaction due to soft tissue irritation. A new HTO system – Tailored Osteotomy Knee Alignment (TOKA®, 3D Metal Printing Ltd, Bath, UK) could potentially address these barriers having a custom titanium plate and titanium surgical guides featuring a unique mechanism for precise osteotomy opening as well as saw cutting and drilling guides. The aim of this study was to assess the accuracy of this novel HTO system using cadaveric specimens; a preclinical testing stage ahead of first-in-human surgery according to the ‘IDEAL-D’ framework for device innovation.

Local ethics committee approval was obtained. The novel opening wedge HTO procedure was performed on eight cadaver leg specimens. Whole lower limb CT scans pre- and post-operatively provided geometrical assessment quantifying the discrepancy between pre-planned and post-operative measurements for key variables: the gap opening angle and the patient specific surgical instrumentation positioning and rotation - assessed using the implanted plate.

The average discrepancy between the pre-operative plan and the post-operative osteotomy correction angle was: 0.0 ± 0.2°. The R2 value for the regression correlation was 0.95.

The average error in implant positioning was −0.4 ± 4.3 mm, −2.6 ± 3.4 mm and 3.1 ± 1.7° vertically, horizontally, and rotationally respectively.

This novel HTO surgery has greater accuracy and smaller variability in correction angle achieved compared to that reported for conventional or other patient specific methods with published data available. This system could potentially improve the accuracy and reliability of osteotomy correction angles achieved surgically.

Abstract

Abstract

The screw fastening torque applied during bone fracture fixation has a decisive influence on subsequent bone healing. Insufficient screw tightness can result in device/construct instability; conversely, excessive torques risk damaging the bone causing premature fixation failure. This effect is even more prominent in osteoporotic bone, a condition associated annually with almost 9 million fractures worldwide. During fracture fixation, screw tightening torque is applied using subjective feel. This approach may not be optimal for patient”s recovery, increasing risk of fixation failure, particularly in osteoporotic bone, and potentially require revision surgical interventions.

Besides bone density, various factors influence the performance of screw fixation. These factors include bone geometry, cortical thickness and time-dependant relaxation behaviour of the bone. If the influence of screw fastening torque on the bone and relationships between these factors was better understood, the surgical technique could be optimised to reduce the risk of complications.

Within this study, we developed an axisymmetric finite element (FE) model of bone screw tightening incorporating viscoelastic behaviour of the cortical bone such as creep and stress relaxation. The model anticipated time-dependent behaviour of the bone for different bone thickness and density after a typical bone fixation screw had been inserted. The idealised model has been developed based on CT scans of bones with varying densities and inserted screws. The model was validated through a series of experiments involving bovine tibiae (4–5 months) to evaluate the evolution of surface strains with time (Ncorr v1.2). Stress distribution was assessed in photoelastic experiments using acrylic analogues. Relaxation tests have been performed in aqueous environment for up to 48 hours to ensure the relaxation would be complete. The creep behaviour (maximum principal strain) was compared against computational predictions. Our early simulations predicted relaxation strains on the surface of the bone to be 1.1% within 24 hours comparing favourably to 1.3% measured experimentally. Stress distribution patterns were in agreement with photoelastic results.

Using experimentally derived viscoelastic properties, the model has the potential to predict creep and stress relaxation patterns after screw insertion with different fastening torques for bones with varying density and geometry. We aim to develop this into a planning tool providing guidance to surgeons for optimal tightening when using screw fixation, particularly in reduced quality bone.

Background

The Nottingham Hip Fracture Score (NHFS) is a risk stratifying score that estimates the 30-day and 12-month mortality rates of hip fracture patients. To date, it has only been validated in few centres in the UK. Our study aims to see how our mortality rates compare with those predicted by the NHFS.

Background

A large proportion of the expense incurred due to hip fractures arises due to secondary factors such as duration of hospital stay and additional theatre time due to surgical complications. Studies have shown that the use of intramedullary (IM) nail fixation presents a statistically higher risk of re-fracture than plating, which has been attributed to the stress riser at the end of the nail. It is not clear, however, if this situation also applies to unstable fractures, for which plating has a higher fixation failure rate. Moreover, biomechanical studies to date have not considered newer designs of IM nails which have been specifically designed to better distribute weight-bearing loads. This aim of this experimental study was to evaluate the re-fracture risk produced by a newer type of nailing system compared to an equivalent plate.

Background

Numerical modelling using Finite Element (FE) Analysis has become ubiquitous in orthopaedic biomechanics, with both commercial and freely available packages widely used. Three FE packages in particular have gained popularity: Abaqus (Simulia); Ansys (ANSYS, Inc.) and FEBio (University of Utah). Although FEBio is now well established, its developers advise that comparisons should be made against more extensively tested software before trusting its results for specific problems. The aim of the study to conduct a comparison of mesh convergence and to provide validated open-source models of the femur for use all three FE packages.

Femoral head collapse is a possible complication after surgical treatment of femoral neck fractures. The purpose of this study was to examine whether implantation of a Sliding Hip Screw (SHS) or an X-Bolt could increase the risk of femoral head collapse. Similar to traditional hip screws, the X-Bolt is implanted through the femoral neck; however, it uses an expanding cross-shape to improve rotational stability. The risk of collapse was investigated alongside patient factors, such as osteonecrosis.

This numerical study assessed the risk of femoral head collapse using linear eigenvalue buckling (an established method [1]), and also from the maximum von Mises stress within the cortical bone. The femoral head was loaded using the pressures reported by Yoshida et al. for a patient sitting down (reported to put the femoral head at greatest risk of collapse [2]), with a peak pressure of 9.4 MPa and an average pressure of 1.59 MPa. The femur was fixed in all degrees of freedom at a plane through the femoral neck. The X-Bolt and SHS were implanted in accordance with the operative techniques. The femoral head and implants were meshed with quadratic tetrahedral elements, and cortical bone was meshed with triangular thin shell elements. A converged mesh seeding density of 1.2 mm was used. All models were create and solved using ABAQUS finite element software (version 6.12, Simulia, Dassault Systèmes, France). The influence of implant type and presence was examined alongside a variety of patient factors:

Osteonecrosis, modelled as a cone of bone of varying angle, and varying modulus values

Twenty-two finite element models were run for each implant condition (intact; implanted with the X-Bolt; implanted with a SHS), resulting in a total of 66 models. The finite element models were validated using experimental tests performed on five 4^th generation composite Sawbones femurs (Malmö, Sweden), and verified against previously published results [1].

No significant difference was found between the X-Bolt and the SHS, for either critical buckling pressure (p=0.964), or the maximum von Mises stress (p=0.274), indicating no difference in the risk of femoral head collapse. The maximum von Mises stress (and therefore the risk of collapse) within the cortical bone was significantly higher for the intact femoral head compared to both implants (X-Bolt: p=0.048, SHS: p=0.002). Of the factors examined, necrosis of the femoral head caused the greatest increase in risk.

The study by Volokh et al. [1] concluded that deterioration of the cancellous bone underneath the cortical shell can greatly increase the risk of femoral head collapse, and the results of the present study support this finding. Interestingly the presence of either an X-Bolt or SHS implant appeared to reduce the risk of femoral head collapse.

Finite element modelling is being extensively used to evaluate the biomechanical behaviour of fractured bone treated with fixation devices. Appropriate modelling of the bone-implant interface is key to quality biomechanical prediction.

The present study considers this interface modelling in the context of locking plates. A majority of previous studies assume the interface to be represented by a tied constraint or a fully bonded interface. Many other studies incorporate a frictional interface but ignore screw threads. This study compares the various interface modelling strategies. An interface with screw threads explicitly included is also considered.

The study finds that interface modelling has significant impact on both the global and local behaviour. Globally, the load-deflection behaviour shows considerable difference depending on the interface model. Locally, the stress-strain environment within the bone close to the screws is significantly altered.

The results show that the widely used tie constraint can overestimate stiffness of a construct which must be correctly predicted to avoid non-union or periprosthetic re-fracture, especially in osteoporotic bone. In addition, the predictions of screw loosening, bone damage and stress shielding are very different when screw threads are included in the model.