Glenoid baseplate positioning for reverse total shoulder replacements (rTSR) is key for stability and longevity. 3D planning and image-derived instrumentation (IDI) are techniques for improving implant placement accuracy. This is a single-blinded randomised controlled trial comparing 3D planning with IDI jigs versus 3D planning with conventional instrumentation. Eligible patients were enrolled and had 3D pre-operative planning. They were randomised to either IDI or conventional instrumentation; then underwent their rTSR. 6 weeks post operatively, a CT scan was performed and blinded assessors measured the accuracy of glenoid baseplate position relative to the pre-operative plan. 47 patients were included: 24 with IDI and 23 with conventional instrumentation. The IDI group were more likely to have a guidewire placement within 2mm of the preoperative plan in the superior/inferior plane when compared to the conventional group (p=0.01). The IDI group had a smaller degree of error when the native glenoid retroversion was >10° (p=0.047) when compared to the conventional group. All other parameters (inclination, anterior/posterior plane, glenoids with retroversion <10°) showed no significant difference between the two groups. Both IDI and conventional methods for rTSA placement are very accurate. However, IDI is more accurate for complex glenoid morphology and placement in the superior-inferior plane. Clinically, these two parameters are important and may prevent long term complications of scapular notching or glenoid baseplate loosening. Image-derived instrumentation (IDI) is significantly more accurate in glenoid component placement in the superior/inferior plane compared to conventional instrumentation when using 3D pre-operative planning. Additionally, in complex glenoid morphologies where the native retroversion is >10°, IDI has improved accuracy in glenoid placement compared to conventional instrumentation. IDI is an accurate method for glenoid guidewire and component placement in rTSA

We present a new technique for TKA implantation which utilizes patient-specific femoral and tibial positioning guides developed from MRI to offer an individualized approach to total knee replacement. This is a prospective non controlled study which aims to analyse the precision of this technique, its advantages and inconvenients in comparison with the conventional instrumented technique. Material. The MRI provides a consistent three-dimensional data set of the patient's anatomy which allows for 3D axis identification. The ideal position and sizing is performed by the surgeon on this 3D model and the patient specific guides are manufactured in advance in order to reproduce the bone cuts corresponding to this positioning and implant size. There are no intramedullary nor extramedullary instruments during the surgery. Method. We compared 20 patients operated with this technique with 20 patients operated with the conventional technique. The hypothesis was a difference < 2° between the 2 techniques. The measured parameters were:. HKS, HKA, tibial slope, femoral rotation on CT. Duration, bleeding, pain on VAS and morphine consumption, active flexion, KSS, Oxford score, recovery of independant walking and delay of return to home. Both groups were identical for gender, age, BMI, etiology, comorbidities, pain and rehabilitation protocols. Results. There were no significant differences on HKA, HKS angles, femoral rotation, active flexion, pain, length of hospital stay. The surgery with the patient specific instruments was 10 minutes shorter than the conventional one (p < 0,05) and the bleeding was inferior with a ratio of 1/3 (p=0,02). There were no complications with this technique and the use of the conventional guides were never necessary with the patient specific instrumentation. Discussion and Conclusion. The patient specific instrumentation for TKA has a precision identical to that of the conventional technique, including for femoral rotation and ligament balance. The advantages of this method are:. Reduced per and post operative bleeding. Shortening of the operative procedure. It is reproducible, including for less experimented surgeons and allows teaching and assistance in a lower technological institution. The number of implant sizes is much inferior (2/9) just as the quantity of instruments to be sterilised. These advantages induce a cost reduction which could be inferior to the price of the procedure

Introduction. The degree of glenoid bone loss associated with primary glenohumeral osteoarthritis can influence the type of glenoid implant selected and its placement in total shoulder arthroplasty (TSA). The literature has demonstrated inaccurate glenoid component placement when using standard instruments and two-dimensional (2D) imaging without templating, particularly as the degree of glenoid deformity or bone loss worsens. Published results have demonstrated improved accuracy of implant placement when using three-dimensional (3D) computed tomography (CT) imaging with implant templating and patient specific instrumentation (PSI). Accurate placement of the glenoid component in TSA is expected to decrease component malposition and better correct pathologic deformity in order to decrease the risk of component loosening and failure over time. Different types of PSI have been described. Some PSI use 3D printed single use disposable instrumentation, while others use adjustable and reusable-patient specific instrumentation (R-PSI). However, no studies have directly compared the accuracy of different types of PSI in shoulder arthroplasty. We combined our clinical experience and compare the accuracy of glenoid implant placement with five different types of instrumentation when using 3D CT imaging, preoperative planning and implant templating in a series of 173 patients undergoing primary TSA. Our hypothesis was that all PSI technologies would demonstrate equivalent accuracy of implant placement and that PSI would show the most benefit with more severe glenoid deformity. Discussion and Conclusions. We demonstrated no consistent differences in accuracy of 3D CT preoperative planning and templating with any type of PSI used. In Groups 1 and 2, standard instrumentation was used in a patient specific manner defined by the software and in Groups 3, 4, and 5 a patient specific instrument was used. In all groups, the two surgeons were very experienced with use of the 3D CT preoperative planning and templating software and all of the instrumentation prior to starting this study, as well as very experienced with shoulder arthroplasty. This is a strength of the study when defining the efficacy of the technology, but limits the generalizability of the findings when considering the effectiveness of the technology with surgeons that may not have as much experience with shoulder arthroplasty and/or the PSI technology. Conversely, it could be postulated that greater improvements in accuracy may be seen with the studied PSI technology, when compared to no 3D planning or PSI, with less experienced surgeons. There could also be differences between the PSI technologies when used by less experienced surgeons, either across all cases or based upon the severity of pathology. When the surgeon is part of the method, the effectiveness of the technology is equally dependent upon the surgeon using the technology. A broader study using different surgeons is required to test the effectiveness of this technology. Comparing the results of this study with published results in the literature, 3D CT imaging and implant templating with use of PSI results in more accurate placement of the glenoid implant when compared to 2D CT imaging without templating and use of standard instrumentation. In previous studies, this was most evident in patients with more severe bone deformity. We believe that 3D CT planning and templating provides the most value in defining the glenoid pathology, as well as in the selection of the optimal implant and its placement. However, it should be the judgment of the surgeon, based upon their experience, to select the instrumentation to best achieve the desired result

Computer-assisted orthopaedic surgery (CAOS) improves mechanical alignment and the accuracy of surgical cuts in the context of total knee arthroplasty. A simplified, CAOS enhanced instrumentation system was assessed to determine if the same effects could be achieved through the use of a less intrusive system. Two cohorts of surgeons (experienced and trainees) performed a series of total knee arthroplasty resections in knee models with and without navigation-enhanced instrumentation. The percentage of resections that deviated from the planned cut by more than 2°or 2mm (outliers) was determined by post-resection advanced imaging for six unique outcome metrics. Within each experience level, the use of the CAOS enhanced system significantly reduced the total percentage of outliers as compared to conventional instrumentation (Figure 1). The experienced users improved from 35% to 4% outliers overall (p < .001) and the trainees from 34% to 10% outliers (p < .001). Comparing across experience levels, the experienced surgeons performed significantly better in only a single resection metric with conventional instrumentation (Figure 2A), varus/valgus tibial alignment, with 8.3% outliers compared to the trainee's 63% outliers (p = .004). The use of CAOS enhanced instrumentation eliminated any differences between the two user groups for all measured resections (Figure 2B). Comparing CAOS enhanced to conventional instrumentation specifically between anatomical deformity types revealed that there is significant improvement (p < .05) with the use of enhanced instrumentation for all three deformity types (Figure 3). These results suggest that non-intrusive CAOS enhanced instrumentation is a viable alternative to conventional instrumentation with possible benefits. This trial also demonstrates that additional experience may not correlate to improved surgical accuracy, and outliers may be less a result of individual surgeon ability or specific anatomic deformities, and more so related to limitations of the instrumentation used or other yet unidentified factors

Introduction. Total knee arthroplasty is a highly effective procedure to improve the quality of life in patients with advanced osteoarthritis. The number of these procedures are expected to grow 174% by 2030. This growth rate is expected to economically strain the health care system. A potential solution to alleviate this problem is the utilization of single use instruments (SUI). Potential advantages of SUI include: improved operating room efficiencies, decreased costs associated with traditional instrument management (sterile processing, shipping), and decreased infection risk. The present study examines the clinical results of SUI compared to standard instrumentation. Furthermore, economic modeling is performed to examine the cost savings that is potentially realized with their use. Materials and Methods. 51 patients receiving a TKA with use of SUI were prospectively compared to 49 patients utilizing standard instrumentation. Knee Society Scores and Radiographic alignment will be evaluated. Adverse events will be recorded. Economic modeling of SUI will be performed in 4 different areas: 1. Decreased infection burden; 2. Operating room logistics; 3. Sterile processing savings; and 4. Instrument logistical savings. Results. The average Pre-operative KSS (Objective/Functional) scores were 48.7/41.6 for the SIU patients compared to 50.2/38.7 for the standard instrumentation patients. Post-operative improvements measured 84.0/72.8 and 83.9/76.4 for the 2 groups respectively. The Pre-operative Hip-Knee-Ankle Angle was 176.2 and 177.0 for the 2 groups. The SUI HKA improved to 179.3 while the standard improved to 178.9. There were no statistical differences between the 2 groups. Furthermore, there were no cases of subsidence, migration, loosening, or infection in either group. There were no SUI procedure abandonments. Economic analysis revealed a decreased risk of Infection burden of $28.08/case. Operating room efficiencies include reduced set-up/take-down time and case efficiency savings/case. This averages $348.14/case. Instrument sterilization savings occur by bypassing the central sterile-processing department completely and models to $700/case. Finally, instrument logistics savings include time and money spent organizing/turning over/shipping instrument sets for cases. This estimate is $112.88/case for a total economic value of $1, 189.10/case. Discussion. In summary, the present study confirms that SUI provides similar clinical and radiographic results to standard instrumentation for TKA. Furthermore, SUI offers significant cost savings/case via potential benefits of reduced risk of infection, increased operating room productivity, and significant tray sterilization and loaner instrumentation cost savings

Total knee arthroplasty is a successful procedure that reduces knee pain and improves function in most patients with knee osteoarthritis. Patient dissatisfaction however remains high, and along with implant longevity, may be affected by component positioning. Surgery in obese patients is more technically challenging with difficulty identifying appropriate landmarks for alignment and more difficult exposure of the joint. Patient specific instrumentation (PSI) has been introduced with the goal to increase accuracy of component positioning by custom fitting cutting guides to the patient using advanced imaging. A strong criticism of this new technology however, is the cost associated. The purpose of this study was to determine, using a prospective, randomized-controlled trial, the cost-effectiveness of PSI compared to standard instrumentation for total knee arthroplasty in an obese patient population. Patients with a body mass index greater than 30 with osteoarthritis and undergoing a primary total knee arthroplasty were included in this study. We randomized patients to have their procedure with either standard instrumentation (SOC) or PSI. At 12-weeks post-surgery patients completed a self-reported cost questionnaire and the Western Ontario and McMaster Osteoarthritis Index (WOMAC). We performed a cost-effectiveness analyses from a public health payer and societal perspective. As we do not know the true cost of the PSI instrumentation, we estimated a value of $100 for our base case analysis and used one-way sensitivity analyses to determine the effect of different values (ranging from $0 to $500) would have on our conclusions. A total of 173 patients were enrolled in the study with 86 patients randomized to the PSI group and 87 to the SOC group. We found the PSI group to be both less effective and more costly than SOC when using a public payer perspective, regardless of the cost of the PSI. From a societal perspective, PSI was both less costly, but also less effective, regardless of the cost of the PSI. The mean difference in effect between the two groups was −1.61 (95% CI −3.48, 026, p=0.091). The incremental cost-effectiveness ratio was $485.71 per point increase in the WOMAC, or $7285.58 per clinically meaningful difference (15 points) in the WOMAC. Overall, our results suggest that PSI is not cost-effective compared to standard of care from a public payer perspective. From a societal perspective, there is some question as to whether the decreased effect found with the PSI group is worth the reduced cost. The main driver of the cost difference appears to be time off of volunteer work, which will need to be investigated further. In future, we will continue to follow these patients out to one year to collect cost and effectiveness data to investigate whether these results remain past 12 weeks post-surgery

A primary goal of shoulder arthroplasty is to place the components in anatomic version. However, traditional instrumentation does not accommodate glenoid wear patterns. Therefore, many investigators have attempted to use computer modeling or CT-based algorithms to create custom targeting guides to achieve this goal. There are some recent studies investigating the use of custom guides. Iannotti et al. published in JBJS-American in 2012 on the use of patient specific instrumentation. There were 31 patients included in the study. The authors found that the planning software and patient specific instrumentation were helpful overall, but particularly of benefit in patients with retroversion in excess of 16 degrees. In this group of patients, the mean deviation was 10 degrees in the standard surgical group and 1.2 degrees in the patient specific instrumentation group. Throckmorton presented a study at the AAOS in 2014 on 70 cadaveric shoulders. There was one high volume surgeon (>100 shoulder arthroplasties a year), two middle volume surgeons (20–50 shoulder arthroplasties a year), and two low volume surgeons (less than 20 shoulder arthroplasties per year). Overall, the custom guide was significantly more accurate than standard instrumentation. The custom guides were found to be especially more accurate among specimens with associated glenoid wear. There were no strong trends to indicate consistent differences between high, medium, and low volume surgeons. The authors concluded that custom guides have narrower standard deviation and fewer significant errors than standard instrumentation. Custom guides continue to evolve for use in shoulder arthroplasty including some guides that allow the surgeon to decide intra-operatively between anatomic shoulder arthroplasty and reverse arthroplasty. Additional studies will be necessary to further define the role of patient specific instrumentation in practice

The reverse total shoulder replacement (rTSR) has excellent clinical outcomes and prosthesis longevity, and thus, the indications have expanded to a younger age group. The use of a stemless humeral implant has been established in the anatomic TSR; and it is postulated to be safe to use in rTSR, whilst saving humeral bone stock for younger patients. The Lima stemless rTSR is a relatively new implant, with only one paper published on its outcomes. This is a single-surgeon retrospective matched case control study to assess short term outcomes of primary stemless Lima SMR rTSR with 3D planning and Image Derived Instrumentation (IDI), in comparison to a matched case group with a primary stemmed Lima SMR rTSR with 3D planning and IDI. Outcomes assessed: ROM, satisfaction score, PROMs, pain scores; and plain radiographs for loosening, loss of position, notching. Complications will be collated. Patients with at least 1 year of follow-up will be assessed. With comparing the early radiographic and clinical outcomes of the stemless rTSR to a similar patient the standard rTSR, we can assess emerging trends or complications of this new device. 41 pairs of stemless and standard rTSRs have been matched, with 1- and 2-year follow up data. Data is currently being collated. Our hypothesis is that there is no clinical or radiographical difference between the Lima stemless rTSR and the traditional Lima stemmed rTSR

Introduction. Given the association of osteoarthritis with obesity, the typical patient requiring total knee arthroplasty (TKA) is often obese. Obesity has been shown to negatively influence outcomes following TKA, as it is associated with increased perioperative complications and poorer clinical and functional outcomes. Achieving proper limb alignment can be more difficult in the obese patient, potentially requiring a longer operation compared to non-obese patients. Patient specific instrumentation (PSI), a technique that utilizes MR- or CT-based customized guides for intraoperative cutting block placement, may offer a more efficient alternative to manual instruments for the obese patient. We hypothesize that the additional information provided by a preoperative MRI or CT may allow surgeons to achieve better alignment in less time compared to manual instrumentation. The purpose of this study was to assess whether PSI offers an improved operation length or limb alignment compared to manual instruments for nonmorbidly and morbidly obese patients. Methods. In this retrospective cohort study, we evaluated 77 PSI TKA and 25 manual TKA performed in obese patients (BMI≥30) between February 2013 and May 2015. During this period, all patients underwent PSI TKA unless unable to undergo MR scanning. All cases were performed by a single experienced surgeon and utilized a single implant system (Zimmer Persona™). PSI cases were performed using the MR-based Zimmer Patient Specific Instrumentation system. Tourniquet times were recorded to determine length of operation. Long-standing radiographs were obtained preoperatively and 4-weeks postoperatively to evaluate limb alignment. Cases were subdivided by nonmorbid obesity (30≤BMI<40) and morbid obesity (BMI≥40) to assess the effect of increasing obesity on outcomes. Results. PSI and manual cohorts were similar with regards to age, gender, and preoperative alignment. Tourniquet time was significantly shorter in the PSI group for nonmorbidly obese patients (PSI 49.8 minutes vs manual 58.3 minutes; p=0.005) (Figure 1). Postoperative mechanical axis was similar between groups for both nonmorbidly obese (PSI 1.8° vs manual 2.9°; p=0.338) and morbidly obese patients (PSI 4.0° vs manual 3.6°; p=0.922). Mechanical axis outliers (greater than 3° neutral), though nonsignificant, were fewer in the PSI group for nonmorbidly obese (PSI 21.8% vs manual 35.3%; p=0.318) and morbidly obese patients (PSI 46.1% vs manual 75.0%; p=0.362). Discussion. We found that PSI significantly shortened operation length for nonmorbidly obese patients compared to manual instruments. Obesity is strongly associated with increased perioperative infection rates, as is prolonged operation length. The decreased operation length achieved with PSI in the nonmorbidly obese patient may as a consequence decrease infection rates, though further study is necessary. Though not statistically significant, PSI showed a trend toward decreasing overall mechanical axis outliers for both nonmorbidly obese and morbidly obese patients. The use of patient specific instrumentation compared to manual instruments has been controversial in the literature. However, patient specific instrumentation may be favorable in the obese patient, offering a shorter operation length and possibly improved alignment

Introduction. Total knee arthroplasty is effective for the management of osteoarthritis of the knee. Conventional techniques utilizing manual instrumentation (MI) make use of intramedullary femoral guides and either extramedullary or intramedullary tibial guides. While MI techniques can achieve excellent results in the majority of patients, those with ipsilateral hardware, post-traumatic deformity or abnormal anatomy may be technically more challenging, resulting in poorer outcomes. Computer-assisted navigation (CAN) is an alternative that utilizes fixed trackers and anatomic registration points, foregoing the need for intramedullary guides. This technique has been shown to yield excellent results including superior alignment outcomes compared to MI with fewer outliers. However, studies report a high learning curve, increased expenses and increased operative times. As a result, few surgeons are trained and comfortable utilizing CAN. Patient-specific instrumentation is an alternative innovation for total knee arthroplasty. Custom guide blocks are fabricated based on a patient's unique anatomy, allowing for the benefits of CAN but without the increased operative times or the high learning curve. In this study we sought to evaluate the accuracy of PSI techniques in patients with previous ipsilateral hardware of the femur. Methods. After reviewing our database of 300 PSI total knee arthroplasty patients, 16 were identified (10 male, 6 female) using the Zimmer NexGen Patient Specific Instrumentation System. Fourteen patients included in the study had a preexisting total hip arthroplasty on the ipsilateral side [Figure 1], 1 had a sliding hip screw, and 1 patient had a cephalomedullary nail. Postoperative mechanical axis alignment measurements were performed using plain long-standing radiographs [Figure 2]. The American Knee Society Score was used to evaluate clinical outcomes postoperatively. Results. Sixteen total knee arthroplasties were performed using PSI, all in the setting of previous ipsilateral hardware placement. The average age at the time of surgery was 72, with patients ranging from 56 to 85 years of age [Table 1]. 11 of the included knees had a preoperative varus alignment and 5 had valgus alignment. The average value of a deformity identified via the preoperative planning software was 7.9°(1.5°–15.7°). The average value of a deformity identified via preoperative radiographs was 10.1°(2.2°–14.7°). Average postoperative mechanical axis was 3.1° (1°–5.3°) measured from plain radiographs. Average angle between the FMA and femoral component was 90.0° (85.3°–94.1°). The average angle between the TMA and tibial component was 90.6°(87.6°–92.9°). The average difference between the femoral mechanical and anatomic axes was 5.9°(3.4°–7.0°). The average discrepancy between medial and lateral joint space on an anterior-posterior standing radiograph was 0.4mm(0.0mm–1.1mm). At an average of 4.5 months follow-up, American Knee Society knee scores show an aggregate average score of 82.94. Conclusions. Patient specific instrumentation (PSI) is an innovative technology in TKA that replaces the use of intramedullary femoral guides and either extramedullary or intramedullary tibial guides. This study demonstrates that PSI is capable of producing favorable radiographic and clinical outcomes despite preexisting ipsilateral hardware, which may otherwise preclude the use of customary manual instrumentation. We believe PSI is an accurate and effective tool for use in patients with preexisting ipsilateral hardware

Background. 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. Development. Surgical Approach: A muscle splitting approach with a reduced incision size (∼6–8cm) was developed that markedly reduces muscle disruption, thus potentially improving healing and function. The split was placed between the infraspinatus and teres-minor (Fig.1) as this further reduces damage, provides an obvious dissection plane, and improves access to the retroverted articular surfaces. This approach, however, precludes the use of standard bone preparation methods/instruments that require clear visualization and en-face articular access. Therefore, a novel guidance technique and instrumentation paradigm was developed. Minimally Invasive Surgical Guidance: 3D printed Patient Specific Guides (PSGs) have been developed for TSA; however, these are designed for traditional, highly invasive approaches providing unobstructed access to each articular surface separately. As the proposed approach does not offer this access, a novel PSG with two opposing contoured surfaces has been developed that can be inserted between the humeral and scapular articular surfaces and use the rotator cuff's passive tension to self-locate (Fig.2). During computer-aided pre-operative planning/PSG design, the two bones are placed into an optimized relative pose and the PSG is constructed between and around them. This ensures that when the physical PSG is inserted intra-operatively, the bones are locked into the preoperatively planned pose. New Instrumentation Paradigm: With the constraints of this minimally invasive approach, a new paradigm for bone preparation/instrumentation was required which did not rely on en-face access. This new paradigm involves the ability to simultaneously create glenoid and humeral guide axes – the latter of which can guide humeral bone preparation and be a working channel for tools – by driving a short k-wire into the glenoid by passing through the humerus starting laterally (Fig.3). By preoperatively defining the pose produced by the inserted PSG as one that collinearly aligns the bones’ guide axes, the PSG and an attached c-arm drill guide facilitate this new lateral drilling technique. Subsequently, bone preparation is conducted using novel instruments (e.g. reamers and drills for creating holes radial to driver axis) powered using a trans-humeral driver and guided by the glenoid k-wire or humeral tunnel. Conclusion. To meet the expectations of increasingly younger TSA patients, advancements in procedural invasiveness and implantation accuracy are needed. This need was addressed by developing a novel, fully integrated surgical approach, PSG system, and instrumentation paradigm, the initial in-vitro results of which have demonstrated acceptable accuracy while significantly reducing invasiveness

Background. Obtaining accurate alignment in total knee arthroplasty (TKA) remains a concern. Patient specific instrumentation (PSI) created using preoperative 3D modelling was developed to offer surgeons a simplified, reliable, efficient and customised TKA procedure. Methods. In this prospective study, 60 patients who underwent TKA with conventional instrumentation and 71 patients operated on using PSI were followed for 1 year.(Table 1) The primary endpoint was surgical time. Secondary endpoints included the number of instrument trays used, radiographic limb alignment and clinical outcomes. Results. Compared with conventional instrumentation, PSI significantly reduced total surgical time (mean, 8.9 minutes; ±3.3 minutes (standard deviation); p=0.038), OR time (8.6±4.2 minutes; p=0.043), and number of instrument trays (6 trays, p<0.001).(Table 2) Mechanical axis malalignment of the lower limb >3° was observed in 14% of PSI patients versus 29% with conventional instrumentation (p=0.043).(Figure 1) PSI predicted the size of the actual femoral and tibial components used in 85.9% and 78.9% of cases, respectively. There were no differences in VAS pain, EQ-5D and Oxford Knee Scores at 1-year follow-up. Conclusion. PSI improves alignment, surgical and OR time over conventional instrumentation, reduces the number of instruments trays used and results in fewer outliers in overall mechanical alignment in the coronal plane. No advantages in terms of clinical outcome were noticed up to 1 year of follow-up

Background. Patient specific instrumentation (PSI) for total knee replacement (TKR) has demonstrated mixed success in simplifying the operation, reducing its costs, and improving limb alignment. Evaluation of PSI with tools such as radiostereometric analysis (RSA) has been limited, especially for cut-through style guides providing mechanical alignment. The primary goal of the present study was to compare implant migration following TKR using conventional and PSI surgical techniques, with secondary goals to examine whether the use of PSI reduces operative time, instrumentation, and surgical waste. Methods. The study was designed as a prospective, randomized controlled trial of 50 patients, with 25 patients each in the PSI and conventional groups, powered for the RSA analysis. Patients in the PSI group received an MRI and standing 3-foot x-rays to construct patient-specific cut-through surgical guides for the femur and tibia with a mechanical alignment. All patients received the same posterior-stabilized implant, with marker beads inserted in the bone around the implants to enable RSA imaging. Intraoperative variables such as time, number of instrumentation trays used, and mass of surgical waste were recorded. Patients underwent supine RSA exams at multiple time points (2&6 weeks, 3&6 months and yearly) with 6 months data currently available. Migration of the tibial and femoral components was calculated using model-based RSA software. WOMAC, SF-12, EQ5D, and UCLA outcome measures were recorded pre-operatively and post-operatively. Results. There were no demographic differences between groups. One patient in the PSI group was revised for infection, and three patients required manipulation, with no revisions or manipulations in the conventional group. There was no difference in maximum total point motion between groups for the tibia (mean 0.50 vs. 0.50 mm, p = 0.98) or femur (mean 0.46 vs. 0.48 mm, p = 0.87). The PSI group displayed greater tibial posterior tilt (p = 0.048, Fig. 1) and greater femoral anterior tilt (p = 0.01) and valgus rotation (p = 0.04, Fig. 2) than the conventional group, but there were no other differences in migrations. The PSI group required less instrument trays than the conventional group (mean 4.8 vs. 8.1 trays, p < 0.0001), but procedure time was equivalent (mean 79 vs. 74 min, p = 0.06). The PSI group produced less recyclable waste (mean 0.3 vs. 1.4 kg, p < 0.001), but total waste (Fig. 3) was equivalent between groups (mean 10.1 vs. 10.6 kg, p = 0.32). At 6 months there was no difference between groups for SF-12, WOMAC, EQ5D, or UCLA scores. Discussion. At early RSA follow-up, the two groups were broadly similar in implant fixation except for small rotational changes in the tibial and femoral components. The PSI group provided minimal or no advantage over the conventional group for operative time, instrumentation used, or surgical waste produced. The observed increase in manipulations in the PSI group is concerning, and requires additional investigation. Further radiographic and economic analysis is underway to determine if there is any benefit to the use of PSI for TKR during the perioperative and early follow-up period. For any figures or tables, please contact authors directly (see Info & Metrics tab above).

BACKGROUND. The aim of Patient-specific instrumentation surgery is to improve accuracy and limit the range of surgical variability. The main purpose of this study is to summarize and compare the radiographic outcomes of TKA performed using Patient-specific instrumentation compared with conventional techniques. PURPOSES. In this study, we compared varus/valgus of the individual prosthesis components, rotation of femoral components and posterior slope of tibial components of 40 TKAs performed using a patient-specific technique with values from a matched control group of patients who were operated on by conventional intramedullary alignment technique. METHODS. We retrospectively evaluated 55 primary TKAs performed for osteoarthritis: conventional instrumentation using the PFC Sigma (n = 15) patient-specific instrumentation using GMK MyKnee© (n = 40). Varus/valgus of the individual prosthesis components, rotation of femoral components and posterior slope of tibial components were measured from CT images taken post operation, whether there were more outliers with one of the two methods. The fraction of outliers (> 3°) was determined. RESULTS. There was excellent reliability with low standard deviations for the determination of femoral component rotation and varus/valgus of the tibial components. There were significantly more outliers in the conventional (26.7%) group than in the patient-specific instrument group (10.0%). Outliers in Varus/valgus of femoral components were comparable between groups (7.5% in the patient-specific instrument group and 6.7% in the conventional instrument group). Other parameters such as posterior slope of tibial components did not differ in terms of outliers. CONCLUSIONS. In this study, Patient-specific instrument was effective in significantly reducing outliers of rotational femoral component and varus/valgus of the tibial components alignment during TKA. Therefore, additional studies are needed to determine whether patient-specific instrumentation improves clinical function or patient satisfaction

Introduction:. Total knee arthroplasty (TKA) is an effective operation for the management of osteoarthritis of the knee. Conventional technique utilizing manual instrumentation (MI) allows for reproducible and accurate execution of the procedure. The most common techniques make use of intramedullary femoral guides and either extrameduallary or intrameduallary tibial guides. While these methods can achieve excellent results in the majority of patients, those with ipsilateral hardware, post-traumatic deformity or abnormal anatomy may preclude the accurate use of these techniques. Patient-specific instrumentation (PSI) is an alternative innovation for total knee arthroplasty. Utilizing magnetic resonance imaging (MRI) or computed tomography (CT), custom guide blocks are fabricated based on a patient's unique anatomy. This allows for the benefits of computer assisted navigation (CAN) but without the increased operative times or the high learning curve associated with it. Furthermore it allows the use of familiar cutting blocks and guides to check the accuracy of the PSI guide blocks. In this study we sought to evaluate the accuracy of PSI techniques in patients with previous ipsilateral hardware, which would make the use of MI technically challenging and possibly subject to inaccuracy. Methods:. After reviewing our database of 300 PSI total knee arthroplasty patients, 16 patients were identified (10 male, 6 female) using the Zimmer NexGen Patient Specific Instrumentation System. Fourteen patients included in the study had a preexisting total hip arthroplasty on the ipsilateral side, 1 had a preexisting sliding hip screw, and 1 patient had a preexisting cephalomedullary nail. Postoperative mechanical axis alignment measurements were performed using plain long-standing radiographs. The American Knee Society Score was used to evaluate clinical outcomes postoperatively. Results:. Sixteen total knee arthroplasties were performed using PSI, all in the setting of previous ipsilateral hardware placement. The average age at the time of surgery was 72, with patients ranging from 56 to 85 years of age. Eleven of the included knees had a preoperative varus alignment and 5 had valgus alignment. The average value of a deformity identified via the preoperative planning software was 7.85°. The average value of a deformity identified via preoperative radiographs was 10.1°. Average postoperative mechanical axis was 3.1° measured from plain radiographs. Average angle between the femoral mechanical axis and femoral component was 90.0°. The average angle between the tibial mechanical axis and tibial component was 90.6°. The average difference between the femoral mechanical and anatomic axes was 5.9°. The average discrepancy between medial and lateral joint space on an anterior-posterior standing radiograph was 0.4 mm. At an average of 4.5 months follow-up, American Knee Society knee scores show an aggregate average score of 82.94. Conclusion:. Patient specific instrumentation is an innovative technology in TKA that replaces the use of intramedullary femoral guides and either extramedullary or intramedullary tibial guides. This study demonstrates that PSI is capable of producing favorable radiographic and clinical outcomes despite preexisting ipsilateral hardware, which may preclude the use of customary manual instrumentation. We believe PSI is an accurate and effective tool for use in patients with preexisting ipsilateral hardware

A recent proposed modification in surgical technique in total knee arthroplasty (TKA) has been the introduction of patient specific instrumentation or custom cutting guides (CCGs). With CCGs, preoperative three-dimensional imaging is used to manufacture cutting blocks specific to a patient's native anatomy, with proposed benefits including their ease of use; a decrease in operative times and instrument trays and improved cost-efficiency; the ability to preoperative plan component size, alignment, and position; and an improvement in postoperative alignment versus the use of standard instrumentation. However, to date the majority of reports have not confirmed these proposed benefits. Prior studies focusing on cost-efficiency have shown limited benefits in terms of operating and room turnover times, which fail to offset the additional cost of preoperative imaging and fabrication of the CCGs. Furthermore, a number of reports have noted the frequent need for surgeon-directed changes and alterations in alignment intraoperatively, along with errors in the predetermined implant size. The use of CCGs has also failed to improve overall mechanical and component alignment versus standard instrumentation in the majority of investigations. Perhaps most importantly, no investigation has demonstrated CCGs to improve clinical outcomes postoperatively. Therefore, in the absence of proven clinical or radiographic improvements, the continued implementation of CCGs must be questioned

Introduction. Patient-specific instrumentation (PSI) is a contemporary method to optimize accuracy of alignment in total knee arthroplasty (TKA). As the potential benefits come at the cost of increased economic and logistic expenses, there is great scientific and practical interest in the actual advantages and reliability of such systems. Therefore, the purpose of the present study was to compare clinical results, radiological limb alignment, and three-dimensional (3D)-component positioning between conventional instrumentation (CVI) and a computed tomographic (CT)-based PSI in primary TKA. Methods. Two-hundred-ninety consecutive patients (300 knees) with severe, debilitating osteoarthritis scheduled for TKA were included in this study using either CVI (n=150) or PSI (n=150). Patients were clinically assessed according to the Knee Society Score (KSS), range of motion (ROM), and visual analog scale for pain (VAS) before and two years after surgery. Hip-knee-ankle angle (HKA) and 3D-component positioning were assessed on postoperative radiographs and CT to evaluate accuracy of CVI and PSI. Results. Data of 222 knees (CVI: n=108, PSI: n=114) were available for analysis after a mean follow up of 28.6±5.2 months. Clinical (KSS knee and function, ROM, VAS) and radiological parameters (HKA) improved significantly from pre to postoperative in both groups. At the early follow up, clinical outcome was comparable between the two groups, whereas KSS function and VAS for pain were significantly better in the PSI group. Mean HKA deviation from the targeted neutral mechanical axis (CVI: 2.2°±1.7°; PSI: 1.5°±1.4°; p<0.001), rates of outliers (CVI: 22.2%; PSI: 9.6%; p=0.016), and 3D-component positioning outliers were significantly lower in the PSI group. Additionally, the accuracy of femoral and tibial component positioning was significantly higher in all planes. At early follow up, all clinical scores were significantly better in the subgroup of HKA non-outliers (HKA: 180°±3°) compared to HKA outliers. Conclusions. CT-based PSI compared to CVI improves accuracy of mechanical alignment restoration and 3D-component positioning in primary TKA. While clinical outcome was comparable between the two instrumentation groups at early follow up, significantly inferior outcome was detected in the subgroup of HKA-outliers

Accurate implant placement is important to the success of joint replacement surgery. Three dimensional pre-operative planning optimizing the ability to define the anatomy and select the desired implant and its location. Linking this information into implant and patient specific instrumentation has been termed smart instrumentation. Single use instruments contain the patient's topographical boney anatomy and implant information. This same information can be placed within a bone model and a reusable instrument placed onto the bone model can be adjusted to capture the information originally in the planning software. This instrument can then be placed into the surgical site, registered to the bone surfaces and used to modify the bone surfaces to replicate the surgical plan. These concepts, technology and devices have been developed and clinically tested in randomized clinical trials for shoulder arthroplasty

Custom instrumentation in TKA utilises pre-operative imaging to generate a customised guide for cutting block placement. The surgeon is able to modify the plan using three-dimensional software. Although this technology is increasingly gaining acceptance, there is a paucity of clinical data supporting it. One hundred and eleven patients underwent primary TKA using the Zimmer Patient-Specific Instrumentation (PSI) system, in 28 of the cases surgical navigation was used to validate the PSI-generated cuts. Alignment measurements included long-leg alignment and biplanar distal femoral and proximal tibial cuts. Further measurements evaluated femoral implant placement in the AP plane, femoral component rotation, measured bone resection and implant sizing accuracy. The mean final limb alignment as recorded by computer-assisted surgical (CAS) tools was 0.3° of varus. Only two limbs were malaligned by greater than 3°. The femoral component had a mean alignment of 0.3° of valgus and 4.5° of flexion (PSI plan 3° flexion). The predicted femoral size was accurate in 89% of cases and the anterior femoral cut was congruent with the anterior cortex in 92% of cases. The PSI-directed femoral component rotation was consistent with the surgeon's perceived rotation in 95% of cases. The posterior condylar bone resection had a mean difference of < 1mm from the predicted resection. The tibial component had a mean alignment of 0.5° of varus and 8.5° of posterior slope (PSI plan 7° posterior slope). The only statistically significant deviation in alignment was the increased tibial slope (p = 0.046). The tibial component size was accurately predicted in 66% of cases. Custom instrumentation in total knee arthroplasty accurately achieved implant and limb alignment in our study. The plan was more reproducible on the femoral slide. The overestimation of tibial slope and tibial sizing incongruity were related to some of the reference points for the software. A potential benefit of this technology is improved mid-flexion stability by accurately determining femoral component size, placement, and rotation. Further studies will need to be conducted to determine the efficiency and cost-effectiveness of this technology

Summary. Single use instrumentation had a significant reduction on OR Turnover time and instrument setup/clean up time compared to traditional instrumentation. Introduction. Recently, focus has shifted to improving OR efficiency by surgeons and hospital admin. The purpose of this study was to determine the effect of traditional instrumentation vs. single use instrumentation (SUI) on OR efficiency in navigated primary TKA. Methods. This prospective randomized study was conducted at a single center, community hospital by a single surgeon. Patients were split into two groups: Group 1 (Navigated Traditional (n=23)) and Group 2 (Navigated SUI (n=26)). Efficiency was examined by measuring specific time intervals based on milestones in the OR preparation, surgical procedure, and OR cleanup. Results. Instrument set up time was reduced by an average of 8.5 minutes (min) in Group2 vs. Group1 (p=0.00). Patient set up took slightly longer in Group2 (1.47 min) but not statistically significant (p=0.50). Both groups had similar procedure time (p= 0.21) and patient OR Time (120 min for both groups p=0.93). Instrument clean up time was significantly shorter in Group 2 (difference 3.44 min (p=0.01). Overall surgical episode was significantly faster in the Group 2 by 9.57 min (p=0.02). Tourniquet time significantly reduced in the Group 2 by 4.92 min (p=0.02). Overall Instrument set up and clean up was faster by 11.94 min in Group 2 vs. Group 1. Notably, the OR turnover time was reduced by 23.52 min in the Group 2 vs. Group 1. Conclusion. Single-use instruments had a significant reduction on OR Turnover time and instrument setup/cleanup time compared to traditional instrumentation. A larger prospective trial is warranted