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Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_2 | Pages 96 - 96
1 Jan 2016
Kawamoto T Iida S
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Background. Variability in component alignment continues to be a major in total knee arthroplasty(TKA). In the long term, coronal plane malalignment has been associated with an increased risk of loosening, insatability, and wear. Recently, patient specific guide in total knee arthroplasty have been introduced, in which preoperative 3-dementional imaging is used to manufacture disposable cutting guide specific to a patient's anatomy. The goals of patient specific guide are to improve the accuracy of post operative alignment and eliminate outlier cases. The aim of this study is to evaluate clinical results and quantify the coronal plane alignment between a group of patients who underwent TKA using patient specific guide versus standard instrumentation. Patients and Method: An unselected consecutive series of seventy patients undergoing primary TKA using the same cruciate retaining cemented total knee system (Vanuard. TM. , Biomet, Inc, warsaw, Indiana USA) between April 2010 and September 2013 were studied. Patients were included only if they were deemed to be candidates for a. Cruciate retaining TKA. Patients were excluded if they had a flexion contracture greater than 40°, or severe valgus or varus deformity. Forty-nine knees was operated a TKA with standard instrumentation method. Subsequently twenty-one knees was received a TKA using CT-based patient specific guide(Signature. TM. ). Postoperatively standing AP hip-to-ankle radiographs were obtained, from which the lower extremity mechanical axis, component angle were measured. The alignment goals were a neutral mechanical axis defined as a hip-to-ankle angle of 0°with the femoral and tibial components aligned perpendicular to the mechanical axis. The total operating time were quantified utilising an operating room database. The total operating time between TKAs performed with standard instrumentation and those performed with patient specific guides was compared in each group. All patients postoperatively was evaluated of clinical results the Japan Orthopedics Association(JOA) Knee scores. Postoperative blood loss volume and postoperative concentrations of D-dimer were also measured. Results. The mechanical axis angle in patient specific guide group was 1.8°, while the standard instrumentation group was 3.4°and there was no statistical significance. The number of outliers for mechanical axis angle was virtually identical between patient specific guide group 29.0% and the standard group 38.8%. The components angle between the two groups did not achieve statistical significance. The operative time in patient specific guide was 117.4 minutes and significantly less compared to the time of standard group 130.4 minutes. The JOA Knee score of standard instrumentation group was 80.8 points, and the score of patient specific guides group was 85.7 points. There was no statistical significance between the two groups on the clinical score. The blood loss volume of between the two group was no different substantially. The postoperative concentrations of D-dimer of patient specific guide group was 5.3(μg/ml), more less significantly than standard group 9.2 (μg/ml). Conclusion. patient specific guide improved operative time and postoperative concentrations of D-dimer in TKA, this study demonstrates patient specific guide to obtain same angle of overall mechanical axis angle and component alignment. The use of patient specific guide did achieve shorter operative time


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_5 | Pages 38 - 38
1 Jul 2020
Govaers K Philips T Vandekelft A
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We report on a cadaveric study and early experience using patient specific drill guides to prevent cortex perforations and reduce the need for a trochanteric osteotomy in revision THA. Mimic software (Materialise) was used for 3D analysis of the cement mantle and cement plug. Based on the CT findings a Cannulated drill guide with the shape of the femoral stem was printed in medical graded nylon intraoperative findings and complications were recorded on videotape using a standard 5mm laparoscope for medullary inspection. Surgical Technique was to attain a pre-operative CT scan with MARS protocol of the proximal femur to evaluate the femoral stem positioning, the 3D anatomy of the cement mantle, the length of the cement plug and the quality of the surrounding bone. Subsequent a 3D printing of patient specific cannulated drill guide with the shape of the removed femoral component but an eccentric cannulation was made. Endoscopic inspection was performed of the inside of the cement mantle, then insertion of the autoclaved cannulated drill guide in the existing cement mantle. After perforation of the distal plug through the PSI drill guide using either a long drill or an ultrasound plug perforation tool (Zimmer Biomet, Warsaw) the excessive cement was removed with standard available flexible femoral shaft reamers (Zimmer Biomet). Further laproscopic examination of the femoral canal performed to verify completeness of the cement removal. Results. CT scans with 3D reconstruction of the existing cement mantle is possible using Modern CT with MARS protocols. After the training on sawbones and cadaveric bones a predictable plug perforation was obtained in all clinical cases. There were no intraoperative cortex perforations and no intraoperative femoral fractures. Conclusion. CT scan analysis of femoral cement mantles together with patient specific drill guides are promising tools to reduce the risk of femoral perforation in revision total hip arthroplasty


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_16 | Pages 54 - 54
17 Nov 2023
Bishop M Zaffagnini S Grassi A Fabbro GD Smyrl G Roberts S MacLeod A
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Abstract. Background. Distal femoral osteotomy is an established successful procedure which can delay the progression of arthritis and the need for knee arthroplasty. The surgery, however, is complex and lengthy and consequently it is generally the preserve of highly experienced specialists and thus not widely offered. Patient specific instrumentation is known to reduce procedural complexity, time, and surgeons’ anxiety levels. 1. in proximal tibial osteotomy procedures. This study evaluated a novel patient specific distal femoral osteotomy procedure (Orthoscape, Bath, UK) which aimed to use custom-made implants and instrumentation to provide a precision correction while also simplifying the procedure so that more surgeons would be comfortable offering the procedure. Presenting problem. Three patients (n=3) with early-stage knee arthritis presented with valgus malalignment, the source of which was predominantly located within the distal femur, rather than intraarticular. Using conventional techniques and instrumentation, distal femoral knee osteotomy cases typically require 1.5–2 hours surgery time. The use of bi-planar osteotomy cuts have been shown to improve intraoperative stability as well as bone healing times. 2. This normally also increases surgical complexity; however, multiple cutting slots can be easily incorporated into patient specific instrumentation. Clinical management. All three cases were treated at a high-volume tertiary referral centre (Istituto Ortopedico Rizzoli, Bologna) using medial closing wedge distal femoral knee osteotomies by a team experienced in using patient specific osteotomy systems. 3. Virtual surgical planning was conducted using CT-scans and long-leg weight-bearing x-rays (Orthoscape, Bath, UK). Patient specific surgical guides and custom-made locking plates were design for each case. The guides were designed to allow temporary positioning, drilling and bi-planar saw-cutting. The drills were positioned such that the drills above and below the osteotomy became parallel on closing following osteotomy wedge removal. This gave reassurance of the achieved correction allowed the plate to be located precisely over the drills. All screw lengths were pre-measured. Discussion. The surgical time reduced to approximately 30 minutes by the third procedure. It was evident that surgical time was saved because no intraoperative screw length measurements were required, relatively few x-rays were used to confirm the position of the surgical guide, and the use of custom instrumentation significantly reduced the surgical inventory. The reduced invasiveness and ease of surgery may contribute to faster patient recovery compared to conventional techniques. The final post-operative alignment was within 1° of the planned alignment in all cases. Declaration of Interest. (a) fully declare any financial or other potential conflict of interest


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 123 - 123
1 Jul 2014
Kerens B Boonen B Schotanus M Kort N
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Summary Statement. This is the first report of a new technique for unicompartmental to total knee arthroplasty revision surgery in which patient specific guides are formed based on preoperative CT imaging. This technique can help to make revision surgery less technically demanding. Introduction. Unicompartmental to total knee arthroplasty revision surgery can be a technically demanding procedure. Joint line restoration, rotation and augmentations can cause difficulties. This study describes a new technique in which single way fitting guides serve to position knee system cutting blocks. Methods. Preoperatively an image of the distal femur and proximal tibia are formed using CT-scanning. This image is used to create patient specific guides that fit in one single position on the contours of the bone and prosthesis in situ. These guides are fixed with pins and thereafter removed. The pins determine the position of the cutting blocks. Ten consecutive revisions were performed using this technique. Results. All guides fitted well. All femoral prostheses were properly inserted using this technique. One proximal tibia however did not have not enough bonestock so that conversion to intramedular referencing was performed. This was to be expected after the preoperative planning. Postoperative position of the prosthesis was good in all cases. Discussion. This new technique can help to make unicompartmental to total knee arthroplasty less demanding. Problems such as the need for augmentations can be predicted in the preoperative planning. Radiation issues due to CT scanning are limited. The instrumentation needs to be redesigned in order to make this technique work in cases with minimal bonestock present


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 53 - 53
1 Nov 2021
ten Heggeler R Schröder F de Graaf F Fluit R Becea D Verdonschot N Hoogeslag R
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Introduction and Objective. After anterior cruciate ligament reconstruction one of the risk factors for graft (re-)rupture is an increased posterior tibial slope (PTS). The current treatment for PTS is a high tibial osteotomy (HTO). This is a free-hand method, with 1 degree of tibial slope correction considered to be equal to 1 or even 1.67 mm of the anterior wedge resection. Error rates in the frontal plane reported in literature vary from 1 – 8.6 degrees, and in the sagittal plane outcomes in a range of 2 – 8 degrees are reported when planned on PTSs of 3 – 5 degrees. Therefore, the free-hand method is considered to have limited accuracy. It is expected that HTO becomes more accurate with patient specific saw guides (PSGs), with an accuracy margin reported in literature of 2 degrees. This proof of concept porcine cadaver case study aimed to investigate whether the use of PSGs improves the accuracy of HTO to less than 2 degrees. Secondly, the reproducibility of tibial slope measurement was evaluated. Materials and Methods. Preoperative MRI images of porcine cadaver knees (n = 3) were used to create 3D anatomical bone models (Mimics, Materialise, Belgium). These 3D models were subsequently used to develop PSGs (3-Matic, Materialise, Belgium) to correct all tibias for 3 degrees PTS and 4 degrees varus. The PSG mediated HTOs were performed by an experienced orthopaedic surgeon, after which postoperative MRI images were obtained. 3D anatomical models of postoperative tibias were created, and tibial slopes were assessed on both pre- and postoperative tibias. The tibial slope was defined as the angle between the mechanical axis and 3D tibial reference plane in the frontal and sagittal plane. The accuracy of the PSG mediated HTO (median and range) was defined as the difference in all possible combinations of the preoperatively planned and postoperatively obtained tibial slopes. To ensure reproducibility, the pre- and postoperative tibial slopes were measured thrice by one observer. The intra-class correlation coefficients (ICCs) were subsequently calculated to assess the intra-rater reliability (SPSS, IBM Corp., Armonk, N.Y., USA). Results. An accuracy within 2 degrees was achieved in all three cases. The median and range in accuracy for each specimen were +0.46 (−0.57 – 1.45), +0.60 (−1.07 – 1.00), and +0.45 (−0.16 – 0.71) degrees in the frontal plane, and −0.45 (−1.97 – 1.22), −0.80 (−2.42 – 1.77), and 0.00 (−2.19 – 1.93) degrees in the sagittal plane. The pre- and postoperatively planned tibial slopes in the frontal and sagittal plane were measured with a good up to excellent reproducibility. The ICCs of the preoperative planned tibial slopes were 0.82 (95% CI, 0.11 – 1.0), and 0.77 (95% CI, 0.17 – 1.0) for the frontal and sagittal plane, respectively. Postoperative, the ICC for the frontal plane was 0.92 (95% CI, 0.43 – 1.0), and 0.67 (95% CI, −0.06 – 0.99) for the sagittal plane. Conclusions. This proof of concept porcine case study showed an accuracy for the PSG mediated HTO within 2 degrees for each specimen. Moreover, the tibial slopes were measured with a good up to excellent reproducibility. Therefore, the PSG mediated HTO seems to be accurate and might be better than the current used free-hand HTO method. These results offer perspective for implementation of PSG mediated HTO to correct PTS and metaphyseal varus


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_4 | Pages 118 - 118
1 Apr 2019
Wakelin E Twiggs J Roe J Bare J Shimmin A Suzuki L Miles B
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Introduction & aims. Resurfacing of the patella is an important part of most TKA operations, usually using an onlay technique. One common practice is to medialise the patellar button and aim to recreate the patellar offset, but most systems do not well control alignment of the patella button. This study aimed to investigate for relationships between placement and outcomes and report on the accuracy of patella placement achieved with the aid of a patella Patient Specific Guide (PSG). Method. A databse of TKR patients operated on by five surgeons from 1-Jan-2014 who had a pre-operative and post-operative CT scan and 6-month postoperative Knee Osteoarthritis and Outcome (KOOS) scores were assessed. Knees were excluded if the patella was unresurfaced or an inlay technique was used. All knee operations were performed with the Omni Apex implant range and used dome patella buttons. A sample of 40 TKRs had a patella PSG produced consisting of a replication of an inlay barrel shaped to fit flush to the patient's patella bone. The centre of the quadriceps tendon on the superior pole of the patella bone and the patella tendon on the inferior were landmarked. 3D implant and bone models from the preoperative CT scans were registered to the post-operative CT scan. The flat plane of the implanted patella button was determined and the position of the button relative to the tendon attachments calculated. Coverage of the bone by the button and patellar offset reconstruction were also calculated. The sample of 40 TKRs for whom a patella PSG was produced had their variation in placement assessed relative to the wider population sample. All surgeries were conducted with Omni Apex implants using a domed patella. Results. A total of 322 patients were identified in the database, and 82 were subsequently excluded as inlay rather than onlay patella. 59% (142) were female and the average age was 68.9 years (+/− 7.2). Coverage percentage of the cut patella surface by the button was 67% (± 7%), with 83% (200) knees having greater than 60%, and 40% (96) greater than 70%. Component position was on average centralised in terms of mediolateral position (0.09mm ± 1.93 lateral). When comparing the alignment of the patients whose knees used PSG guides with those who did not, it was found there was a statistically significant reduction in the variation that both external rotation error and flexional error had (p-values 0.048 and 0.022 respectively.). Excess medialisation of the patella button was found to weakly correlate with reduced postoperative KOOS symptoms scores (coefficient=0.14, p-value = 0.035). When subdivided into patients who reported knee clicking sometimes or more often and those who did not, patients with highly medialised buttons had a 1.5× likelihood of reporting clicking of their knee joint (p-value = 0.036). Conclusions. The patella-femoral joint remains a crucial component in the TKA knee, but the process of resurfacing the bone is not well controlled and can negatively influence patient outcomes. PSG's are one potential mechanism of controlling patella component alignment


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_4 | Pages 74 - 74
1 Apr 2019
Giles J Broden C Tempelaere C Rodriguez-Y-Baena F
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PURPOSE. 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). MATERIALS AND METHODS. 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). RESULTS. 3D translational accuracy of PSG physical registration was: humeral PSG- 2.2 ± 1.1 mm and scapula PSG- 2.5 ± 0.7 mm. The humeral and scapular guide holes had angular accuracies of 6.4 ± 3.2° and 8.1 ± 5.1°, respectively; while the guide hole positional accuracies on the articular surfaces (which will control bone preparation translational accuracy) were 2.9 ± 1.2 mm and 2.8 ± 1.3 mm. Final implantation accuracy in translation was 2.9 ± 3.0 mm and 5.7–6.8 ± 2.2–4.0° across the implants’ three rotations for the humerus and in translation was 2.8 ± 1.5 mm and 2.3–4.3 ± 2.2–4.4° across the implants’ three rotations for the scapula (Figure 3). DISCUSSION. The overall implantation accuracy was similar to results of previously reported open, unassisted TSA (3.4 mm & 7–12°, Hendel et al., 2012, Nguyen et al., 2009). Analysis of the positional PSG registration accuracy very closely mirrors the final implantation accuracy (humerus:2.2 mm vs 2.9 mm, and scapula:2.2 mm vs 2.8mm), thus, this is likely the primary predictor of implantation accuracy. Furthermore, the greatest component of PSG registration error was mediolateral translation (i.e. along the guiding axis) and thus should not affect guide hole drilling accuracy. The drilled guide hole positional and angular error was low for the humerus (2.9 mm and 6.4°) but somewhat higher in rotation (8.1°) for the glenoid which may indicate a slight shift in the PSG prior to guide hole drilling due to the weight of the arm applied when the PSGs are locked together. In conclusion, this work has detailed the step-by-step surgical errors associated with the developed system and demonstrated that it achieves similar accuracy to open, unassisted TSA, while avoiding complications related to muscular transection and dislocation. Therefore, we believe this technique is worthy of clinical investigation


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_5 | Pages 109 - 109
1 Mar 2017
Reitman R Pierrepont J Shimmin A McMahon S Kerzhner E
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Introduction. Restoration of the femoral head centre during THR should theoretically improve muscle function and soft tissue tension. The aim of this study was to assess whether 3D planning and an accurately controlled neck osteotomy could help recreate hip anatomy. Methods. 100 consecutive THR patients received OPS. TM. 3D femoral planning. For each patient a 3D stem+head position was pre-operatively planned which restored the native head height, restored global offset after cup medialisation and reproduced anterior offset, in the superior-inferior, medial-lateral and anterior-posterior directions respectively. The femoral osteotomy was planned preoperatively and controlled intra-operatively with a patient specific guide. All procedures were performed through a posterior approach with a TriFit/Trinity uncemented implant combination. Post-op implant position was determined from CT. Results. The mean difference between planned and achieved head height was 0.9mm (−1.2mm to 4.6mm). The mean difference between planned and achieved medial offset was −0.9mm (−6.2mm to 3.1mm). The mean difference between planned and achieved anterior offset was 3.2mm (−0.4mm to 6.6mm). Resultant 3D change between the planned and achieved head centre was 4.4mm (0.6mm to 9.1mm). The change in anterior offset was strongly correlated (r=0.78) to the change in achieved stem anteversion in comparison to the plan; mean values of 16.3° and 10.5° respectively. Conclusions. In this single centre pilot study, femoral centre of rotation was accurately reproduced by using 3D templating and controlling the femoral neck osteotomy with a patient-specific guide


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_4 | Pages 130 - 130
1 Jan 2016
Wilson C Stevens A Mercer G Krishnan J
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Alignment and soft tissue balance are two of the most important factors that influence early and long term outcome of total knee arthroplasty. Current clinical practice involves the use of plain radiographs for preoperative planning and conventional instrumentation for intra operative alignment. The aim of this study is to assess the Signature. TM. Personalised system using patient specific guides developed from MRI. The Signature. TM. system is used with the Vanguard. R. Complete Knee System. This system is compared with conventional instrumentation and computer assisted navigation with the Vanguard system. Patients were randomised into 3 groups of 50 to either Conventional Instumented Knee, Computer Navigation Assisted Knee Arthroplasty or Signature Personalised Knee Arthoplasty. All patients had the Vanguard Total knee Arthroplasty Implanted. All patients underwent Long leg X-rays and CT Scans to measure Alignment at pre-op and 6 months post-op. All patients had clinical review and the Knee Society Score (KSS) at 1 year post surgery was used to measure the outcome. A complete dataset was obtained for 124 patients. There were significant differences in alignment on Long leg films ot of CT scan with perth protocol. Notably the Signature group had the smallest spread of outliers. In conclusion the Signature knee system compares well in comparison with traditional instrumentation and CAS Total Knee Arthroplasty


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_1 | Pages 75 - 75
1 Feb 2015
Victor J
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Osteotomy is one of the oldest orthopaedic interventions and has evolved significantly over the years. The procedure is well established as a biomechanical solution in the treatment of arthritis and instability of the knee. The operation is technically demanding and carries risks of neurovascular injury, inadequate fixation and under- or overcorrection. These technical problems have given osteotomy significant headwind in the orthopaedic community. The relative success of knee arthroplasty (uni or total) in the past decade has fed the perception that this procedure is the only remaining treatment to be trusted for patients with knee arthritis. However, both registry data and single center studies often show disappointing results for knee arthroplasty in the young, active and demanding patient population. Osteotomy has a significant role for these patients, provided they have unicompartmental arthritis with constitutional malalignment. Also, more complex deformities as seen in the post-traumatic setting often need a biomechanical approach based upon osteotomy principles. Recently, technology was developed to allow the surgeon perform a three-dimensional evaluation of the deformity and prediction of postoperative alignment. Patient specific guides with a broad fit on the femur or tibia can guide the osteotomy and fixation accurately, within 2 degrees of accuracy. With this technological approach, a new dawn for osteotomy appears on the horizon


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_5 | Pages 54 - 54
1 Feb 2016
Darwood A Emery R Reilly P Richards R Baena FRY Tambe A
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Introduction. Optimal orthopaedic implant placement is a major contributing factor to the long term success of all common joint arthroplasty procedures. Devices such as 3D printed bespoke guides and orthopaedic robots are extensively described in the literature and have been shown to enhance prosthesis placement accuracy. These technologies have significant drawbacks such as logistical and temporal inefficiency, high cost, cumbersome nature and difficult theatre integration. A radically new disruptive technology for the rapid intraoperative production of patient specific instrumentation that obviates all disadvantages of current technologies is presented. Methods. An ex-vivo validation and accuracy study was carried out using the example of placing the glenoid component in a shoulder arthroplasty procedure. The technology comprises a re-usable table side machine, bespoke software and a disposable element comprising a region of standard geometry and a body of mouldable material. Anatomical data from 10 human scapulae CT scans was collected and in each case the optimal glenoid guidewire position was digitally planned and recorded. The glenoids were isolated and concurrently 3D printed. In our control group, guide wires were manually inserted into 1 of each pair of unique glenoid models according to a surgeon's interpretation of the optimal position from the anatomy. The same surgeon used the guidance system and associated method to insert a guide wire into the second glenoid model of the pair. Achieved accuracy compared to the pre-operative bespoke plan was measured in all glenoids in both the conventional group and the guided group. Results. The technology was successfully able to intraoperatively produce sterile, patient specific guides according to a pre-operative plan in 5 minutes including device set up and planning, at a minimal cost. In the manual insertion group, average accuracy achieved was 6.8° and 1.58mm with respect to the plan compared to the guided group where an average of 0.74mm and 1.72 ° was achieved


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_22 | Pages 89 - 89
1 Dec 2016
Lombardi A
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Patient specific instruments have been developed in response to the conundrum of limited accuracy of intramedullary and extramedullary alignment guides and chaos caused by computer assisted orthopaedic surgery. This technology facilitates preoperative planning by providing the surgeon with a three dimensional (3-D) anatomical reconstruction of the knee, thereby improving the surgeon's understanding of the preoperative pathology. Intramedullary canal penetration of the femur and tibia is unnecessary, and consequently, any potential for fat emboli is eliminated. Component position and alignment are improved with a decrease in the number of outliers. Patient specific instruments utilise detailed magnetic resonance imaging (MRI) or computed tomography (CT) scans of the patient's knee with additional images from the hip and ankle for determination of critical landmarks. From these studies a 3-D model of the patient's knee is created and with integration of rapid prototyping technology, guides are created to apply to the patient's native anatomy to direct the placement of the cutting jigs and ultimately the placement of the components. The steps in considering utilization of patient specific guides are as follows: 1) the surgeon determines that the patient is a candidate for TKA, 2) an MRI or CT scan is obtained at an approved facility in accordance with a specific protocol, 3) the MRI or CT is forwarded to the manufacturer, 4) the manufacturer creates the 3-D reconstructions, anatomical landmarks are identified, implant size is determined, and ultimately femoral and tibial component implant placement is determined via an algorithm, 4) the surgical plan is executed, 5) the physician reviews and modifies or approves the plan, 6) the guides are then produced via rapid prototyping technology and delivered to the hospital for the surgical procedure. Guides generated from MRIs are designed to uniquely register on cartilage surface whereas guides produced from CT scans must register on bony anatomy. There are currently two types of guides produced: those which register on the femur and tibia and allow for the placement of pins to accommodate the standard resection blocks; and those produced by some manufacturers which accommodate the saw blade and therefore are a combination of resection and pin guides. The utilization of patient-specific positioning guides in TKA has several benefits. They facilitate preoperative planning, obviate the need for violation of the intramedullary canals, reduce operating times and improve OR efficiency, decrease instrumentation requirements and thereby reduce potential for perioperative contamination. They are easier to use than computer navigation with no capital equipment purchase and no significant learning curve. Most importantly, patient-specific guides facilitate accurate component position and alignment, which ultimately has been shown to enhance long-term survivorship in total knee arthroplasty


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_22 | Pages 117 - 117
1 Dec 2016
Cobb J
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Patients presenting with arthrosis following high tibial osteotomy (HTO) pose a technical challenge to the surgeon. Slight overcorrection during osteotomy sometimes results in persisting medial unicompartmental arthrosis, but with a valgus knee. A medial UKA is desirable, but will result in further valgus deformity, while a TKA in someone with deformity but intact cruciates may be a disappointment as it is technically challenging. The problem is similar to that of patients with a femoral malunion and arthrosis. The surgeon has to choose where to make the correction. An ‘all inside’ approach is perhaps the simplest. However, this often means extensive release of ligaments to enable ‘balancing’ of the joint, with significant compromise of the soft tissues and reduced range of motion as a consequence. As patients having HTO in the first place are relatively high demand, we have explored a more conservative option, based upon our experience with patient matched guides. We have been performing combined deformity correction and conservative arthroplasty for 5 years, using PSI developed in the MSk Lab. We have now adapted this approach to the failed HTO. By reversing the osteotomy, closing the opening wedge, or opening the closing wedge, we can restore the obliquity of the joint, and preserve the cruciate ligaments. Technique: CT based plans are used, combined with static imaging and on occasion gait data. Planning software is then used to undertake the arthroplasty, and corrective osteotomy. In the planning software, both tibial and femoral sides of the UKA are performed with minimal bone resection. The tibial osteotomy is then reversed to restore joint line obliquity. The placing of osteotomy, and the angling and positioning in relation to the tibial component are crucial. This is more important in the opening of a closing wedge, where the bone but is close to the keel cut. The tibial component is then readjusted to the final ‘Cartier’ angle. Patient guides are then made. These include a tibial cutting guide which locates both the osteotomy and the arthroplasty. At operation, the bone cuts for the arthroplasty are made first, so that these cuts are not performed on stressed bone. The cuts are not in the classical alignment as they are based upon deformed bone so the use of patient specific guides is a real help. The corrective osteotomy is then performed. If a closing wedge is being opened, then a further fibular osteotomy is needed, while the closing of an opening wedge is an easier undertaking. Six cases of corrective osteotomy and partial knee replacement are presented. In all cases, the cruciates have been preserved, together with normal patello-femoral joints. Patient satisfaction is high, because the deformity has been addressed, restoring body image. Gait characteristics are those of UKA, as the ACL has been preserved and joint line obliquity restored


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 19 - 19
1 Jan 2016
Marel E Walter L Solomon M Shimmin A Pierrepont J
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Achieving optimal acetabular cup orientation in Total Hip Replacement (THR) remains one of the most difficult challenges in THR surgery (AAOR 2013) but very little has been added to useful understanding since Lewinnek published recommendations in 1978. This is largely due to difficulties of analysis in functional positions. The pelvis is not a static reference but rotates especially in the sagittal plane depending upon the activity being performed. These dynamic changes in pelvic rotation have a substantial effect on the functional orientation of the acetabulum, not appreciated on standard radiographs [Fig1]. Studies of groups of individuals have found the mean pelvic rotation in the sagittal plane is small but large individual variations commonly occur. Posterior rotation, with sitting, increases the functional arc of the hip and is protective of a THR in regards to both edge loading and risk of dislocation. Conversely Anterior rotation, with sitting, is potentially hazardous. We developed a protocol using three functional positions – standing, supine and flexed seated (posture at “seat-off” from a standard chair). Lateral radiographs were used to define the pelvic tilt in the standing and flexed seated positions. Pelvic tilt was defined as the angle between a vertical reference line and the anterior pelvic plane (defined by the line joining both anterior superior iliac spines and the pubic symphysis). In the supine position pelvic tilt was defined as the angle between a horizontal reference line and the anterior pelvic plane. Supine pelvic tilt was measured from computed tomography. Proprietary software (Optimized Ortho, Sydney) based on Rigid Body Dynamics then modelled the patients’ dynamics through their functional range producing a patient-specific simulation which also calculates the magnitude and direction of the dynamic force at the hip and traces the contact area between prosthetic head/liner onto a polar plot of the articulating surface, Fig 2. Given prosthesis specific information edge-loading can then be predicted based on the measured distance of the contact patch to the edge of the acetabular liner. Delivery of desired orientation at surgery is facilitated by use of a solid 3D printed model of the acetabulum along with a patient specific guide which fits the model and the intra-operative acetabulum (with cartilage but not osteophytes removed) - an incorporated laser pointer then marks a reference point for the reamer and cup inserter to replicate the chosen orientation. Results and conclusions. The position of the pelvis in the sagittal plane changes significantly between functional activities. The extent of change is specific to each patient. Spinal pathology is a potent “driver” of pelvic sagittal rotation, usually unrecognised on standard radiographs. Pre-operative patient assessment can identify potential orientation problems and even suitability for hard on hard bearings. Optimal cup orientation is likely patient-specific and requires an evaluation of functional pelvic dynamics to pre-operatively determine the target angles. Post-operatively this technique can identify patient and implant factors likely to be causing edge loading leading to early failure in metal on metal bearings or squeaking in ceramic on ceramic bearings


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_9 | Pages 31 - 31
1 May 2016
Pierrepont J McMahon R Miles B McMahon S
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Introduction. Appropriate acetabular cup orientation is an important factor in reducing instability and maximising the performance of the bearing after Total Hip Arthroplasty (THA). However, postoperative analyses of two large cohorts in the US have shown that more than half of cups are malorientated. In addition, there is no consensus as to what inclination and anteversion angles should be targeted, with contemporary literature suggesting that the orientation should be customised for each individual patient. The aim of this study was to measure the accuracy of a novel patient specific instrumentation system in a consecutive series of 22 acetabular cups, each with a customised orientation. Methodology. Twenty-two consecutive total hip replacement patients were sent for Trinity Optimized Positioning System (OPS) acetabular planning (Optimized Ortho, Sydney). The Trinity OPS planning is a preoperative, dynamic analysis of each patient performing a deep flexion and full extension activity. The software calculates the dynamic force at the hip to be replaced and plots the bearing contact patch as it traces across the articulating surface. The software modelled multiple cup orientations and the alignment which best centralised the load was chosen by the surgeon from the preoperative reports. Once the target orientations had been determined, a unique patient specific guide was 3D printed and used intra-operatively with a laser guided system to achieve the planned alignment, Fig 1. All patients received a post-operative CT scan at 3 months and the radiographic cup inclination and anteversion was measured. The study was ethically approved by The Avenue Hospital Human Research Ethics Committee, Trial Number 176. Results. The mean planned radiographic inclination, reference to the Anterior Pelvic Plane (APP), was 42.8° (range 36.2° – 50.1°). The mean planned radiographic anteversion, reference to the APP, was 28.3° (range 19.4° – 37.0°). Only 23% of the planned orientations fell within Lewinnek's “safe zone”, taking into consideration that that this safe zone is not comparable to the coronal plane of radiographs. However, all 22 cups were planned within a range of 40° ± 10° of inclination and 25° ± 10° of anteversion, when referenced to the coronal plane when supine. The mean inclination difference between the planned and achieved orientations was −1.3° (range −7.6° – 9.2°). The mean anteversion difference was 1.2° (range −5.3° – 7.0°). The mean absolute difference was 4.2° for inclination (range 0.4° – 9.2°) and 3.6° for anteversion (range 0.6° – 7.0°). All 22 cups were within ±10° of their intended target orientation, Fig 2. All 22 cups were within the range of 40° ± 10° of inclination and 25° ± 10° of anteversion, when reference to the coronal plane when supine, Fig 3. Conclusions. These are the early results of a new technology for planning and delivering a customised acetabular cup orientation. We expect further improvements in accuracy with current developments. However, the results suggest that Trinity OPS is a simple way to achieve a patient-specific cup orientation, with accuracy comparable to imageless navigation


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_30 | Pages 62 - 62
1 Aug 2013
Frame MC
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3D printing and rapid prototyping in surgery is an expanding technology. It is often used for preoperative planning, procedure rehearsal and patient education. There have been recent advances in orthopaedic surgery for the development of patient specific guides and jigs. The logical next step as the technology advances is the production of custom orthopaedic implants. I aimed to use freely available open source software and online cloud 3D printing services to produce a patient specific orthopaedic implant without requiring the input of a university department, specialised equipment or implant companies. Using standard CT scan DICOM data, a 3D surface reconstruction was made of a patient's uninjured radial head using open source DICOM viewer OsiriX. This was then manipulated in other open source software packages called Meshlabs and Netfabb to create a mirror image 3D model of the radial head with a stem to produce a prosthesis suitable to replace the contralateral fractured radial head. This was then uploaded and printed in stainless steel via cloud printing service . Shapeways.com. . The model produced was an exact replication of the patient's original anatomy, except a mirror image suitable for replacement of the contralateral side. The process did not involve any specialist equipment or input from an academic department or implant company. It took a total of 10 days to produce and cost less than £40. From this study I was able to show that production of patient specific orthopaedic implants is possible. It also highlights that the technology is accessible to all, and does not require any special equipment or large investment. It can be achieved quickly and for a very small financial outlay. As a proof of concept it has been very successful


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 51 - 51
1 Dec 2013
Dujardin J Vandenneucker H Bellemans J Victor J
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A prospective randomized trial on 128 patients with end-stage osteoarthritis was conducted to assess the accuracy of patient-specific guides. In cohort A (n = 64), patient- specific guides from four different manufacturers (Subgroup A1 Signature ®, A2 Trumatch ®, A3 Visionaire ® and A4 PSI ®) were used to guide the bone cuts. Surgical navigation was used as an intraoperative control for outliers. In cohort B (n = 64), conventional instrumentation was used. All patients of cohorts A and B underwent a postoperative full-leg standing X-ray and CT scan for measuring overall coronal alignment of the limb and three-planar alignment of the femoral and the tibial component. Three-planar alignment was the primary endpoint. Deviation of more than three degrees from the target in any plane, as measured with surgical navigation or radiologic imaging, was defined as an outlier. In 14 patients (22%) of cohort A, the use of the patient-specific guide was abandoned because of outliers in more than one plane. In 18 patients (28%), a correction of the position indicated by the guide, was made in at least one plane. A change in cranial-caudal position was most common. Cohort A and B showed a similar percentage of outliers in long-leg coronal alignment (24.6%, 28.1%, p = 0.69), femoral coronal alignment (6.6%, 14.1%, p = 0.24) and femoral axial alignment (23%, 17.2%, p = 0.50). Cohort A had more outliers in coronal tibial alignment (14.6%) and sagittal tibial alignment (21.3%) than cohort B (3.1%, p = 0.03 and 3.1%, p = 0.002, respectively). These data indicate that patient specific guides do not improve accuracy in total knee arthroplasty


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XL | Pages 29 - 29
1 Sep 2012
Cobb J
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The current generation of knee replacements are based upon assumptions from kinematic studies that preceded their designs. These implants were further limited by practical restrictions imposed by affordability, materials and manufacturing, and finally by the methods available to surgeons to prepare the bone and implant them. The early designs of knee seldom distinguished left from right, as the early kinematic work had not appreciated the very different functions of the medial and lateral compartments. Trochlea shape and position within devices was also limited by the published work on the way the knee bends. Surgical insertion has been limited to landmark based registration, and adjustment of the kinematics by soft tissue releases. However accurately such operations were performed, they could not restore normal function, as the kinematics of the joint were quite different from the normal knee. Recently, we have begun to appreciate three distinct axes of the knee joint: the flexion axis, the extension axis and the trochlea axis. These can be reliably found from 3d imaging, but cannot be immediately established by eye, or by conventional jigs, which must rely on unreliable landmarks acquired in surgery. The current market leaders in knee joint sales do not reflect these three axes in their joint designs, so the instrumentation used to insert them cannot restore the kinematics of the normal knee. The emerging partial replacements can be designed to take the axes and their resulting kinematics into account. If they are then inserted using robotic assistance, or patient specific guides, they can restore joints to these axes reliably. Knee function following such conservative surgery reflects this improvement in kinematics with higher functional scores and faster top walking speeds than has ever been possible using conventional devices inserted using the conventional landmark based surgical techniques


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 322 - 322
1 Jul 2014
Frame M
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Summary Statement. We are taking very expensive cutting edge technology, usually reserved for industry, and using it with the help of open source free software and a cloud 3D printing services to produce custom and anatomically unique patient individual implants for only £32. This is approx. 1/100. th. of the traditional cost of implant production. Introduction. 3D printing and rapid prototyping in surgery is an expanding technology. It is often used for preoperative planning, procedure rehearsal and patient education. There have been recent advances in orthopaedic surgery for the development of patient specific guides and jigs. The logical next step as the technology advances is the production of custom orthopaedic implants. Our aim was to use freely available open source software, a personal computer and consumer access online cloud 3D printing services to produce an accurate patient specific orthopaedic implant without utilising specialist expertise, capital expenditure on specialist equipment or the involvement of traditional implant manufacturing companies. This was all to be done quickly, cost effectively and in department. Methods & Materials. Using standard computed tomography (CT) scan and the standard file format of digital imaging and communications in medicine (DICOM) data, a 3D surface reconstruction was made of a cadaveric radial head using the software OsiriX (DICOM image processing software for Apple OS X). This data was then processed in Meshlabs (a system for the processing and editing of unstructured 3D triangular meshes) to create a mirror image 3D model of the radial head with a stem added to produce prosthesis suitable to replace the contra lateral radial head. Both packages are distributed under open-source licensing—Lesser General Public Licence (LGPL)—and are therefore free. This was then uploaded and 3D printed using a process of selective laser sintering (SLS) in stainless steel via the commercial cloud printing service . Shapeways.com. . Results & Conclusions. The model produced was an accurate mirror image replica of the patient's original anatomy (all measurements equal +/− 0.2mm using TS411212 Digital Vernier Expert Caliper 300mm P=0.001 Showing no significant statistical difference. Production from original CT scan took a total of 10 days and the total cost including shipping was £32. This was then re-implanted in to the contra lateral cadaveric radius. We achieved our aims and goals of quick, cost effective and accurate implant creation


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_8 | Pages 73 - 73
1 May 2014
Berend M
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Component and limb alignment are important considerations during Total Knee Arthroplasty (TKA). Three-dimensional positioning of TKA implants has an effect on implant loosening, polyethylene stresses, and gait. Furthermore, alignment, in conjunction with other implant and patient variables such as body mass index (BMI) influence osseous loading and failure rates. Fortunately, implant survivorship after TKA has been reported to be greater than 95% at 20 years, despite up to 28% of TKAs having component position greater than 3 degrees from neutral. How good are we at positioning TKA implants with standard instrumentation? Ritter, et al examined 6,070 primary TKAs and found that from 2 degrees – 7 degrees of valgus, the failure rate was 0.5% for limb alignment. Importantly 28% of the TKAs were outside the 2 degrees – 7 degrees range in the hands of experienced surgeons. What about cases with retained hardware or deformities that preclude IM or EM guides. Clearly there is room for improvement in surgical technique, but this improvement must be (1) time efficient and cost effective; (2) have a low complication rate, and (3) be reproducible with a minimal learning curve. One of the technologies that has been developed to help surgeons implant and position TKA components is a patient matched guide. Preoperative computerised planning of the arthroplasty, development of patient specific guides, combined with limited mechanical instruments has been a significant step forward for the surgeon and patient. “The logistical benefits include possible decreased operating room time, decreased turnover time, less time spent sterilising and preparing trays, less inventory, less strain on surgical technicians and nurses, and no capital cost associated with computer navigation. Patient benefits include potentially less tourniquet time, less surgical exposure, no requirement of intramedullary canal preparation, and improved mechanical alignment, which may translate to increased implant longevity. Surgeon benefits include potentially more accurate landmark registration than computer navigation, more efficient surgery, decreased intraoperative stress due to less required decision making, and the ability to perform more surgeries due to time saved.”. Ng, et al compared 569 TKAs performed with patient-specific positioning guides and 155 with manual instruments. The overall mean hip-knee-ankle angle for patient-specific positioning guides (180.6 degrees) was similar to manual instrumentation (181.1 degrees), but there were fewer ± 3 degrees hip-knee-ankle angle outliers with patient-specific positioning guides (9%) than with manual instrumentation (22%)