3D printed Patient Specific Guides (PSGs) can improve the accuracy of joint-replacement. Pre-operative CT bone models are used to design a PSG that fits the patient's specific bone geometry. A key design requirement is to maximize docking robustness such that the PSG can maintain a stable position in the planned location. However, current PSG designs are typically manually defined, lack a quantitative assessment of robustness, and have an unknown consistency of docking rigidity between patients. Limited research exists on the stability and robustness of surgical guides, and no software packages are available to facilitate this analysis. Our goal was to develop such a software. In this paper, the contact between a patient's bone and the PSG is modelled using robotic grasping theory, and its docking robustness is quantified by analysis of the PSG's grasp wrench space (GWS) (i.e. the combination of contact forces and torques between the bone and PSG). To this end, a PSG design and analysis tool with a graphical user interface was developed in MATLAB. This tool allows the user to load shapes (e.g. STL bone models), select and manipulate possible contact points, and optimize the contact point locations according to the largest-minimum resisted wrench (LRW) that the grasp can resist in any direction. The LRW is a grasp quality metric equivalent to the radius of the largest (hyper)sphere contained within the convex hull of the GWS, and its value can be evaluated using frame-variant GWS calculations (i.e. centroid-dependent) or frame-invariant GWS calculations (i.e. centroid-independent).Introduction
Methods
Patient Specific Guides (PSGs) are used to increase the accuracy of arthroplasty. PSGs achieve this by incorporating geometry that fits in one unique position and orientation on a patient's bone. Sufficient docking rigidity ensures PSGs do not shift before being fixed by pins. Despite the importance of PSG docking rigidity, minimal research has been conducted on this issue. This study aims to determine whether commercially available PSGs, in their equilibrium position, provide sufficient stability for reliable surgical use. A commercially available PSG (Glenoid PSG, BLUEPRINT™, Wright Medical) was analyzed and tested in this study; the mechanical performance of this guide was assessed using a custom testing apparatus mounted to a universal testing machine (UTM) (MTI-10k, Materials Testing Inc), assembled with a high-precision load cell (MiniDyn Type 9256C, Kistler). The apparatus accepts an additively manufactured glenoid surrogate and was designed to transform vertical crosshead forces from the UTM into PSG-applied forces transverse to the glenoid plane along anterior-posterior and superior-inferior axes and PSG-applied torques about lateral, anterior, and superior axes. Three trials were recorded for each force and torque application. Prior to each test, the glenoid surrogate and PSG were articulated together with a constant 27N compressive force — equivalent to the normal force exerted by a surgeon using the guide — applied using springs. Forces were recorded when the guide was displaced 2mm by transverse loads or 5° by torque application; if the guide visibly dislodged from the glenoid surrogate before either criterion was met, force was recorded at the time of dislodgement. If no PSG movement occurred, testing ceased at 75N or 1.19N⋅m, depending on the test type.Introduction
Materials and Methods
Reverse shoulder arthroplasty (RSA) provides an effective alternative to anatomic shoulder replacements for individuals with cuff tear arthropathy, but certain osteoarthritic glenoid deformities make it challenging to achieve sufficient long term fixation. To compensate for bone loss, increase available bone stock, and lateralize the glenohumeral joint center of rotation, bony increased offset RSA (BIO-RSA) uses a cancellous autograft for baseplate augmentation that is harvested prior to humeral head resection. The motivations for this computational study are twofold: finite element (FE) studies of BIO-RSA are absent from the literature, and guidance in the literature on screw orientations that achieve optimal fixation varies. This study computationally evaluates how screw configuration affects BIO-RSA graft micromotion relative to the implant baseplate and glenoid. A senior shoulder specialist (GSA) selected a scapula with a Walch Type B2 deformity from patient CT scans. DICOM images were converted to a 3D model, which underwent simulated BIO-RSA with three screw configurations: 2 divergent superior & inferior locking screws with 2 convergent anterior & posterior compression screws (SILS); 2 convergent anterior & posterior locking screws and 2 superior & inferior compression screws parallel to the baseplate central peg (APLS); and 2 divergent superior & inferior locking screws and 2 divergent anterior & posterior compression screws (AD). The scapula was assigned heterogeneous bone material properties based on the DICOM images’ Hounsfield unit (HU) values, and other components were assigned homogenous properties. Models were then imported into an FE program for analysis. Anterior-posterior and superior-inferior point loads and a lateral-medial distributed load simulated physiologic loading. Micromotion data between the RSA baseplate and bone graft as well as between the bone graft and glenoid were sub-divided into four quadrants.INTRODUCTION
METHODS
To validate the efficacy and accuracy of a novel patient specific guide (PSG) and instrumentation system that enables minimally invasive (MI) short stemmed total shoulder arthroplasty (TSA). Using Amirthanayagam et al.'s (2017) MI posterior approach reduces incision size and eliminates subscapular transection; however, it precludes glenohumeral dislocation and the use of traditional PSGs and instruments. Therefore, we developed a PSG that guides trans-glenohumeral drilling which simultaneously creates a humeral guide tunnel/working channel and glenoid guide hole by locking the bones together in a pre-operatively planned pose and drilling using a c-shaped drill guide (Figure 1). To implant an Affinis Short TSA system (Mathys GmbH), novel MI instruments were developed (Figure 2) for: humeral head resection, glenoid reaming, glenoid peg hole drilling, impaction of cruciform shaped humeral bone compactors, and impaction of a short humeral stem and ceramic head. The full MI procedure and instrument system was evaluated in six cadaveric shoulders with osteoarthritis. Accuracy was assessed throughout the procedure: 1) PSG physical registration accuracy, 2) guide hole accuracy, 3) implant placement accuracy. These conditions were assessed using an Optotrak Certus tracking camera (NDI, Waterloo, CA) with comparisons made to the pre-operative plan using a registration process (Besl and McKay, 1992).PURPOSE
MATERIALS AND METHODS
Patient Specific Instruments (PSIs) are becoming increasingly common in arthroplasty but have only been used with highly invasive surgical approaches that can result in significant complications. We have previously described a novel PSI for minimally invasive total shoulder arthroplasty and shown that it can accurately guide the creation of guide holes in the humerus and scapula. However, conducting shoulder replacement in a minimally invasive environment precludes the use of traditional instruments. In this work, we describe and evaluate the efficacy of a set of novel instruments that, in conjunction with our PSIs, enable accurate minimally invasive total shoulder arthroplasty to be achieved for the first time. The key components of this surgical procedure are: 1) a new minimally invasive posterior surgical approach that avoids the need for muscle transection; 2) a novel PSI that enables accurate guide tunnels to be simultaneously created in the humerus and scapula using a c- shaped drill guide that mates to the PSI; 3) a custom humeral head resection guide that uses the humeral guide tunnel; 4) a novel reamer and 3D metal printed gear mechanism for radial displaced drilling both powered by a central driver placed through the humeral head; and 5) custom impactors for glenoid and humeral implantation – the latter is achieved using a modular slap hammer that is guided by the central humeral drill hole. Accuracy of this system was assessed at each surgical step using an optical tracking camera and an iterative closest point registration method to map measurements to the pre-operative plan. The accuracy results for the physical PSI registration and guide hole drilling were found to be in line with our previously reported results: the intra-articular guide hole locations were 2.2mm and 3.9mm for the humerus and glenoid with angular errors of 2.8° and 8°, respectively. After humeral resection, the humeral cut plane had an angular error of 10.1°. The final humeral implant location had an error of 12.1° and 1.9mm. For the glenoid implant, the positional error was 3.8mm with angular errors of 3.3° ante-retroversion and 8.6° supero- inferior inclination. We believe that these initial results demonstrate that this minimally invasive PSI and instrumentation system can accurately guide total shoulder replacement while avoiding the complications of open surgery. A full cadaveric testing series is currently being completed.
Despite reverse total shoulder arthroplasty (RTSA) being primarily indicated for massive rotator cuff tears, it is often possible to repair portions of the infraspinatus and subscapularis of patients undergoing this procedure. However, there is disagreement regarding whether these tissues should be repaired, as their effects remain unclear. Therefore, we investigated the effects of rotator cuff repair and changes in humeral and glenosphere lateralisation (HLat & GLat) on deltoid and joint loading. Six shoulders were tested on an in-vitro muscle driven active motion simulator. Cuff tear arthropathy was simulated in each specimen, which was then implanted with a custom adjustable RTSA fitted with a six axis load sensor. We assessed the effects of 4 RTSA configurations (i.e. all combinations of 0&10mm of HLat & GLat) on deltoid force, joint load, and joint load angle during abduction with/out rotator cuff repair. Deltoid and joint loads recorded by the load cell are reported as a % of Body Weight (%BW). Repeated measures ANOVAs and pairwise comparisons were performed with p<0.05 indicating significance. Cuff repair interacted with HLat & GLat (p=0.005, Fig. 1) such that with no HLat, GLat increased deltoid force without cuff repair (8.1±2.1%BW, p=0.012) and this effect was significantly increased with cuff repair (12.8±3.2%BW, p=0.010). However, adding HLat mitigated this such that differences were not significant. HLat and GLat affected deltoid force regardless of cuff status (−2.5±0.7%BW, p=0.016 & +7.7±2.3%BW, p=0.016, respectively). Rotator cuff repair did significantly increase joint load (+11.9±2.1%BW, p=0.002), as did GLat (+13.3±1.5%BW, p<0.001). The increases in deltoid and joint load caused by rotator cuff repair confirm that it acts as an adductor following RTSA and increases deltoid work. Additionally, cuff repair's negative effects are exacerbated by GLat, which strengthens its adduction affect, while Hlat increases the deltoid's abduction effect thus mitigating the cuff's antagonistic effects. Cuff repair increases concavity compression within the joint; however, Hlat produces a similar effect by wrapping the deltoid around the greater tuberosity – which redirects its force – and does so without increasing the magnitude of muscle and joint loading. The long-term effects of increased joint loading due to rotator cuff repair are unknown, however, it can be postulated that it may increase implant wear, and the risk of deltoid fatigue. Therefore, RTSA implant designs which improve joint compression without increasing muscle and joint loading may be preferable to rotator cuff repair.
Total Shoulder Arthroplasty (TSA) has been shown to improve the function and pain of patients with severe degeneration. Recently, TSA has been of interest for younger patients with higher post-operative expectations; however, they are treated using traditional surgical approaches and techniques, which, although amenable to the elderly population, may not achieve acceptable results with this new demographic. Specifically, to achieve sufficient visualization, traditional TSA uses the highly invasive deltopectoral approach that detaches the subscapularis, which can significantly limit post-operative healing and function. To address these concerns, we have developed a novel surgical approach, and guidance and instrumentation system (for short-stemmed/stemless TSA) that minimize muscle disruption and aim to optimize implantation accuracy.
Background
Development
