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Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_9 | Pages 131 - 131
1 May 2016
Pierrepont J Riddell W Miles B Baré J Shimmin A
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Introduction. The primary purpose of Total Hip Arthroplasty (THA), aside from pain relief, is to restore hip biomechanics such that the patient experiences no discernible functional deficit, while also providing an environment conducive to implant longevity. Key factors in determining a successful THA include achieving the desired pre-operative femoral offset and leg length, as well as the restoration of range of motion (ROM). Minor leg length discrepancies (LLDs), less than a centimetre, are common after THA and usually well tolerated. However, in some patients, even these small discrepancies are a source of dissatisfaction. More significant discrepancies can be a risk factor for more serious concerns such as nerve injury, abnormal gait and chronic pain. The level of the femoral neck osteotomy is a critical step in reproducing a planned femoral stem position. Frequently the femoral osteotomy is too high and can lead to an increase in leg length and varus stem positioning. If the desired implant positions are identified from preoperative 3D templating, a planned femoral osteotomy can be used as a reference to recreate the correct leg length and offset. The aim of this study was assess the accuracy of a 3D printed patient-specific guide for delivering a pre-planned femoral neck osteotomy. Methodology. A consecutive series of 33 patients, from two surgeons at a single institution, were sent for Trinity OPS pre-operative planning (Optimized Ortho, Australia). Trinity OPS is a pre-operative, dynamic, patient-specific modelling system for acetabular and femoral implant positioning. The system requires a pre-operative CT scan which allows patient specific implant sizing as well as positioning. Once the preoperative implant positioning plan was confirmed by the surgeon, a patient-specific guide was designed and printed to enable the planned level of femoral neck osteotomy to be achieved, Fig 1. All patients received a Trinity cementless acetabular component (Corin, UK) and a cementless TriFit TS femoral component (Corin, UK) through a posterior approach. The achieved level of osteotomy was confirmed postoperatively by doing a 3D/2D registration, in the Mimics X-ray Module (Materialise, Belgium), of the planned 3D resected femur to the postoperative AP radiograph, Fig 2. The image was then scaled and the difference between the planned and achieved level of osteotomy was measured (imatri Medical, South Africa), Fig 2. Results. The mean absolute difference between the planned and achieved osteotomy level was 0.7mm (range 0.1mm − 6.6mm). Only 1 patient had a difference of more than 3mm, Fig 3. Of the 33 patients, 28 had a difference of less than 1mm. Conclusions. The results from this initial series of 33 patients suggest that a 3D printed patient-specific guide can be a simple and accurate way of intraoperatively reproducing a planned femoral neck osteotomy, though there was one significant outlier. Whether the 3D planning, patient-specific guide and accurate femoral osteotomy can then be used to achieve precise leg length and offset recreation is the subject of an on-going evaluation


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 119 - 119
1 Apr 2019
Cabarcas B Cvetanovich G Orias AE Inoue N Gowd A Liu J Verma N
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Background. Accurate placement of the glenoid component in total shoulder arthroplasty (TSA) is critical to optimize implant longevity. Commercially available patient-specific instrumentation systems can improve implant placement, but may involve considerable expense and production delays of up to six weeks. The purpose of this study was to develop a novel technique for in-house production of 3D-printed, patient-specific glenoid guides, and compare the accuracy of glenoid guidepin placement between the patient-specific guide and a standard guide using a cadaveric model. Methods. Twenty cadaveric shoulder specimens were randomized to receive glenoid guidepin placement via standard TSA guide (Wright Medical, Memphis, TN) or patient-specific guide. Three-dimensional scapular models were reconstructed from CT scans with Mimics 20.0 imaging software (Materialise NV, Leuven, Belgium). A pre-surgical plan was created for all specimens for the central glenoid guidepin of 0º version and inclination angles. Central pin entry and exit points were also calculated. Patient-specific guides were constructed to achieve the planned pin trajectory in Rhino3D software (Robert McNeel & Associates, Seattle, WA). Guides were 3D-printed on a Form2 printer with Formlabs Dental SG Resin (Formlabs, Somerville, MA). Glenoid labrum and cartilage were removed with preservation of other soft tissues in all specimens to mimic intraoperative TSA conditions. A fellowship-trained, board-eligible orthopaedic surgeon placed a 2.5 mm diameter titanium guidepin into each glenoid using the assigned guide for each specimen. After pin placement, repeat CT scans were performed, and a blinded measurer used superimposed 3D scapular reconstructions to calculate deviation from the pre-surgical plan in version and inclination angles, dot product angle, and guide pin entry and exit points. Student's t tests were performed to detect differences between pin placements for the two groups. Results. Cadaver age, sex, and BMI did not differ between groups (p>0.05 for all). Average production cost and time for the patient-specific guides were $29.95 and 4 hours and 40 minutes per guide, respectively. Guidepin version deviation did not differ between the patient-specific and standard guides (1.59º ± 1.60º versus 2.88 º ± 2.11º, respectively, p=0.141). Guidepin inclination deviation was significantly lower in the patient-specific group (1.54º ± 1.58º versus 6.42º ± 5.03º, p=0.009), similarly the dot product angle was lower in the patient-specific compared to standard guide group (2.35º ± 1.66º versus 7.48º ± 4.76º, p=0.005). Glenoid entry site exhibited less deviation for the patient-specific compared to standard guide (0.75mm ± 0.54mm versus 2.05mm ± 1.19mm, p=0.006). Glenoid exit site also was closer to the target for the patient- specific compared to standard group (1.75mm ± 0.99mm versus 4.75mm ± 2.97mm, p=0.010). Conclusion. We present a novel technique for in-house production of 3D-printed, patient-specific glenoid guides for TSA glenoid pin placement. These patient-specific guides improved pin placement accuracy based on 3D-CT measurements compared to standard TSA guides in a cadaveric model. Our patient-specific glenoid guides can be produced on-demand, in-house, inexpensively, and with significantly reduced time compared to commercially available guides. Future studies are required to validate these findings in clinical applications and determine the potential impact on implant longevity


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_28 | Pages 21 - 21
1 Aug 2013
Kunz M Rudan J Mann S Twiss R Ellis R
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Introduction. Computer-assisted methods for acetabulum cup navigation have shown to be able to improve the accuracy of the procedure, but are time-consuming and difficult to use. The goal of this project was to develop an easy-to-use navigation technique, requiring minimal equipment for acetabular cup alignment. Material. A preoperative CT scan was obtained, a 3D model of the acetabulum was created, the pelvic plane determined and the cup orientation planned. A registration area, which included the accessible part of the acetabular fossa and the surrounding articular surface, was chosen for the individualised guide. A guidance cylinder, aligned along the planned cup orientation, was attached in the centre of the guide. To transfer the planned alignment information from the registered guide to the impacting of the cup, we developed an intraoperative guidance method based on inertia sensors. The sensors were aligned orthogonal to the central cylinder of the patient-specific guide and the orientation was recorded. At the time of impacting the cup, the sensors were attached to the impactor and the surgeon used the recorded information for the alignment of the impactor. Results. To measure the accuracy of the proposed registration method, we performed an in-vitro trial on three fresh-frozen hemipelves with seven participants. The deviation between the planned and registered inclination averaged 3.01° (StDev 5.7). In anteversion, we measured an average error of 4.33° (StDev 2.8). We tested the feasibility of the proposed method in a clinical trial. The postoperative radiographic measured angles in this trial were 45° anteversion (planned 45°) and 25° inclination (planned 20°). Discussion. We introduce a novel method for computer-assisted cup alignment, which is easy to integrate into the surgical workflow. Our preliminary results suggest that this method is accurate. However, further clinical studies are necessary to verify its clinical feasibility and accuracy


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).


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_5 | Pages 24 - 24
1 Feb 2016
Giles JW Baena FRY
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Patient Specific Instruments (PSIs) are becoming an increasingly common method to provide surgeons with assistance in accurately performing procedures; however, to our knowledge, these new instruments have only been applied to traditional, highly invasive surgical approaches. However, PSIs have the potential to decreased surgical invasiveness by reducing the surgeon's need to clearly visualise anatomical landmarks. Therefore, we designed and evaluated a novel PSI for minimally invasive shoulder arthroplasty.

The proposed minimally invasive approach prevents en face access to the articular surfaces and thus the PSI was designed to guide the accurate placement of a trans-humeral bone tunnel which would permit surgical steps to be conducted. To accurately create this tunnel and place a guide pin in the glenoid, the PSI was designed as a two sided guide that incorporates unique anatomical features from both bones, which would lock the two bones in a predefined pose relative to one another. Proper registration of the PSI is aided by the joint's passive compression force, which is not disrupted due to the soft tissue sparing approach. Once the bones are locked together, a guide pin could be passed through the humeral head – creating a bone tunnel to guide later humeral bone preparation – and into the glenoid to guide reaming and drilling. By designing the guide in this way, it is possible to avoid the need to perform surgical steps with a clear en face view.

The PSI was created by loading 3D reconstructed CT models of the humerus and scapula into a CAD package, aligning the desired humeral and scapular guide axes such that the bones' relative pose is fully defined, and finally constructing the guide itself between and around the articular surfaces, such that sufficient anatomical features are incorporated to provide complete physical registration with the bones. This PSI was subsequently customised, based on a cadaveric specimen and fabricated using a 3D printer. The PSI's usability and accuracy in achieving the pre-operative plan were then assessed using optical tracking and surface based registration procedure.

Results of the evaluation demonstrated that the designed PSI is capable of accurately registering the two bones to within 5mm and 14° of the intended pre-operative plan, while also effectively reducing the invasiveness of the surgical procedure. Therefore, this novel PSI may represent a new avenue to improve the clinical impact of CAOS systems, by achieving good surgical accuracy, but with a greatly reduced invasiveness.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_4 | Pages 109 - 109
1 Apr 2019
Wakelin E Twiggs J Moore E Miles B Shimmin A
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Introduction & aims

Patient specific instrumentation (PSI) is a useful tool to execute pre-operatively planned surgical cuts and reduce the number of trays in surgery. Debate currently exists around improved accuracy, efficacy and patient outcomes when using PSI cutting guides compared to conventional instruments. Unicompartmental Knee Arthroplasty (UKA) revision to Total Knee Arthroplasty (TKA) represents a complex scenario in which traditional bone landmarks, and patient specific axes that are routinely utilised for component placement may no longer be easily identifiable with either conventional instruments or navigation. PSI guides are uniquely placed to solve this issue by allowing detailed analysis of the patient morphology outside the operating theatre. Here we present a tibia and femur PSI guide for TKA on patients with UKA.

Method

Patients undergoing pre-operative planning received a full leg pass CT scan. Images are then segmented and landmarked to generate a patient specific model of the knee. The surgical cuts are planned according to surgeon preference. PSI guide models are planned to give the desired cut, then 3D printed and provided along with a bone model in surgery. PSI-bone and PSI-UKA contact areas are modified to fit the patient anatomy and allow safe placement and removal.

The PSI-UKA contact area on the tibia is defined across the UKA tibial tray after the insert has been removed. Further contact is planned on the tibial eminence if it can be accurately segmented in the CT and the anterior superior tibia on the contralateral compartment, see example guide in Figure 1. Contact area on the femur is defined on the superior trochlear groove, native condyle, femur centre and femoral UKA component if it can be accurately segmented in the CT.

Surgery was performed with a target of mechanical alignment using OMNI APEX PS implants (Raynham, MA). The guide was planned such that the OMNI cut block could be placed on the securing pins to translate the cut. Component alignment and resections values were calculated by registering the pre-operative bones and component geometries to post-operative CT images.


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.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_2 | Pages 117 - 117
1 Jan 2016
Kobayashi M Nagaya Y Goto H Nozaki M Mitsui H Iguchi H Otsuka T
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Introduction

Patient specific surgical guide (PSSG) is a relatively new technique for accurate total knee arthroplasty (TKA), and there are many reports supporting PSSG can reduce the rate of outlier in the coronal plane. We began to use PSSG provided by Biomet (Signature®) and have reported the same results. Before using Signature, we performed TKA by modified gap technique (parallel cut technique) to get the well balanced flexion gap. Signature is the one of the measured resection technique using the anatomical landmarks as reference points on the images of CT or MR taken before surgery. We usually measure the center gap width and gap balance during operation with the special device “knee balancer”(Fig. 1) that can be used on patella reposition. After cutting all of the bone with Signature, gap balance in the extension position was very good but the gap balance was shown slight lateral opening in the 90 degrees flexion position. So we have changed the surgical procedure. We use Signature for cutting only distal femur and proximal tibia to get extension gap and apply the modified gap technique to decide the rotation of the femoral component (Signature with modified gap technique).

The purpose of this study is to compare the gap balance between the two techniques.

Materials & Methods

From November, 2012 through March, 2014, 50 CR type TKA (Vanguard Knee®, Biomet) in osteoarthritis patients were performed using Signature. 25 TKA were performed using only Signature (group S) and other 25 TKA were done using Signature with modified gap technique (group SG). After all osteotomies of femur and tibia were completed, applying femoral trial, center gap width and gap balance (plus means lateral opening angle) were measured using knee balancer with respect to 30 degrees of the knee flexion angle from zero to 120 degrees (Fig. 2).


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_3 | Pages 19 - 19
23 Feb 2023
Sandow M Cheng Z
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This paper presents an ongoing review of the use of a wedge-shaped porous metal augments in the shoulder to address glenoid retroversion as part of anatomical total shoulder arthroplasty (aTSA). Seventy-five shoulders in 66 patients (23 women and 43 men, aged 42 to 85 years) with Walch grade B2 or C glenoids underwent porous metal glenoid augment (PMGA) insertion as part of aTSA. Patients received either a 15º or 30º PMGA wedge (secured by screws to the native glenoid) to correct excessive glenoid retroversion before a standard glenoid component was implanted using bone cement. Neither patient-specific guides nor navigation were used. Patients were prospectively assessed using shoulder functional assessments (Oxford Shoulder Score [OSS], American Shoulder and Elbow Standardized Shoulder Assessment Form [ASES], visual analogue scale [VAS] pain scores and forward elevation [FE]) preoperatively, at three, six, and 12 months, and yearly thereafter, with similar radiological surveillance. Forty-nine consecutive series shoulders had a follow-up of greater than 24 months, with a median follow-up of 48 months (range: 24–87 months). Median outcome scores improved for OSS (21 to 44), ASES (24 to 92), VAS (7 to 0), and FE (90º to 140º). Four patients died, but no others were lost to follow-up. Apart from one infection at 18 months postoperatively and one minor peg perforation, there were no complications, hardware failures, implant displacements, significant lucency or posterior re-subluxations. Radiographs showed good incorporation of the wedge augment with correction of glenoid retroversion from median 22º (13º to 46º) to 4º. All but four glenoids were corrected to within the target range (less than 10º retroversion). The porous metal wedge-shaped augments effectively addressed posterior glenoid deficiency as part of aTSA for rotator cuff intact osteoarthritis, producing satisfactory clinical outcomes with no signs of impending future failure


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_8 | Pages 67 - 67
1 May 2016
Jones G Jaere M Clarke S Cobb J
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Introduction. Opening wedge high tibial osteotomy is an attractive surgical option for physically active patients with early osteoarthritis and varus malalignment. Unfortunately use of this surgical technique is frequently accompanied by an unintended increase in the posterior tibial slope, resulting in anterior tibial translation, and consequent altered knee kinematics and cartilage loading(1). To address this unintended consequence, it has been recommended that the relative opening of the anteromedial and posterolateral corners of the osteotomy are calculated pre-operatively using trigonometry (1). This calculation assumes that the saw-cut is made parallel to the native posterior slope; yet given the current reliance on 2D images and the ‘surgeon's eye’ to guide the saw-cut, this assumption is questionable. The aim of this study was to explore how accurately the native posterior tibial slope is reproduced with a traditional freehand osteotomy saw-cut, and whether novel 3D printed patient-specific guides improve this accuracy. Methods. 26 fourth year medical students with no prior experience of performing an osteotomy were asked to perform two osteotomy saw-cuts in foam cortical shell tibiae; one freehand, and one with a 3D printed surgical guide (Embody, London) that was designed using a CT scan of the bone model. The students were instructed to aim for parallelity with a hinge pin which had been inserted (with the use of a highly conforming 3D printed guide) parallel to the posterior slope of the native joint. For the purpose of analysis, the sawbones were consistently orientated along their mechanical and anatomical tibial axes using custom moulded supports. Digital photographs taken in the plane of the osteotomy were analysed with ImageJ software to calculate the angular difference in the sagittal plane between the hinge-pin and saw-cut. Statistical analysis was performed with SPSS v21 (Chicago, Illinois); a paired t-test was used to compare the freehand and patient-specific guide techniques. Statistical significance was set at a p-value <0.05. Results. Using the traditional freehand technique, the mean difference in angle between the hinge pin and osteotomy saw-cut was 5.40 (SD 4.6), which contrasted with 1.40(SD 1) when the osteotomy was performed using a 3D printed guide [See Figure 1]. This difference was significant (p<0.001). Discussion. This study highlights the large degree of error in the posterior slope of an osteotomy saw-cut when performed using a freehand technique, and which is likely to be a factor in the unintended change in tibial slope commonly observed in post-operative patients. We found that a 3D printed patient-specific osteotomy guide significantly improved the accuracy and reduced the variability of this procedure. A follow-up multi-centre clinical trial is currently underway to ascertain whether these results are replicated in-vivo


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_8 | Pages 68 - 68
1 May 2016
Jones G Clarke S Jaere M Cobb J
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The treatment of patients with osteoarthritis of the knee and associated extra-articular deformity of the leg is challenging. Current teaching recognises two possible approaches: (1) a total knee replacement (TKR) with intra-articular bone resections to correct the malalignment or (2) an extra-articular osteotomy to correct the malalignment together with a TKR (either simultaneously or staged). However, a number of these patients only have unicompartmental knee osteoarthritis and, in the absence of an extra-articular deformity would be ideal candidates for joint preserving surgery such as unicompartmental knee replacement (UKR) given its superior functional outcome and lower cost relative to a TKR [1). We report four cases of medial unicondylar knee replacement, with a simultaneous extra-articular osteotomy to correct deformity, using novel 3D printed patient-specific guides (Embody, UK) (see Figure 1). The procedure was successful in all four patients, and there were no complications. A mean increase in the Oxford knee score of 9.5, and in the EQ5D VAS of 15 was observed. To our knowledge this is the first report of combined osteotomy and unicompartmental knee replacement for the treatment of extra-articular deformity and knee osteoarthritis. This technically challenging procedure is made possible by a novel 3D printed patient-specific guide which controls osteotomy position, degree of deformity correction (multi-plane if required), and orientates the saw-cuts for the unicompartmental prosthesis according to the corrected leg alignment. Using 3D printed surgical guides to perform operations not previously possible represents a paradigm shift in knee surgery. We suggest that this joint preserving approach should be considered the preferred treatment option for suitable patients


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. 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. 95-B, Issue SUPP_34 | Pages 282 - 282
1 Dec 2013
DeClaire J Lombardi A Berend K
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Background:. Coronal malalignment occurs frequently in total knee arthroplasty (TKA) and reduces implant longevity and function. Designed to improve consistency and efficiency, patient- specific positioning guides (PSPG) generated from preoperative imaging studies represent a paradigm shift from manual instrumentation (MI) and intraoperative computer navigation. Purposes:. We compare the efficacy of PSPG to MI in (1) restoring mechanical axis of the extremity and (2) achieving neutral alignment of the femoral and tibial components. Methods:. We retrospectively examined 696 postoperative anteroposterior standing long-leg radiographs after TKA (545 PSPG, 151 MI) by two surgeons. Coronal alignment was assessed by determining the zone in which the overall mechanical axis (OMA) passed through the knee, measuring the hip-knee-ankle (HKA) angle between the tibial and femoral mechanical axes, and finally, noting the alignment of the femoral and tibial components with respect to their mechanical axes. Results:. The OMA passed through the central third more frequently with PSPG than MI for both surgeons (JHD: 86.6% vs. 77%, p = 0.02; AVL: 86.4% vs. 74.5%, p = 0.11). For the senior author, while percent of HKA outliers >3ï,° was similar between PSPG and MI, the mean error from neutral for these patients was significantly less with PSPG than MI (4.50ï,° vs. 5.25ï,°, p = 0.0031). The tibial component demonstrated no significant difference between PSPG and MI. With PSPG, average individual deviation from neutral for the femoral component was significantly less (0.91ï,° vs. 1.34ï,°, p = 0.0005) and had fewer outliers >2ï,° (4.9% vs. 19.6%, p = 0.017). Discussion:. Improved coronal alignment in total knee arthroplasty (TKA) is associated with greater patient satisfaction, better functional scores and increased implant longevity [11,30,31,36]. Recently, preoperative three-dimensional imaging and custom manufacturing have enabled the development of patient-specific positioning guides (PSPG). Designed to improve consistency and efficiency, PSPG represents a paradigm shift away from intramedullary and extramedullary guides, or manual instrumentation (MI), and an evolution from intraoperative computer-assisted navigation (CAN). Even in the hands of experienced surgeons, MI frequently results in significant component angulation and mechanical axis malalignment [32]. Multiple studies support the restoration of a neutral axis as a critical factor in implant performance and potential longevity of total knee arthroplasty [2, 3, 5, 18, 41, 44]. Intraoperative CAN has been shown to improve precision and accuracy of alignment compared to MI with a reduction in the number of outliers (less than 3ï,° varus/valgus) [32, 38] and the amount of blood loss [39], but is hindered by time-consuming landmark registration, increased operative length [7], greater cost, the risk for stress fracture, pin loosening, and a substantial learning curve [6, 22, 29, 43]. Patient-specific positioning guides, on the other hand, purportedly eliminate many of the disadvantages of CAN while still allowing the bone resections to match the measured overall mechanical axis. While accurate and precise alignment guides are potent tools in restoring the proper overall mechanical axis, they are not a substitute for careful preoperative planning, good clinical and intraoperative judgment, appropriate soft tissue balancing, and precise implantation technique. Nevertheless, patient-specific positioning guides can provide the first step in the right direction to a successful TKA. Conclusions:. Patient-specific positioning guides can assist in restoration of the mechanical axis with reduction in outliers. Level of Evidence: Level III, retrospective case-control study


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLIV | Pages 82 - 82
1 Oct 2012
Paul L Docquier PL Cartiaux O Delloye C Banse X
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Primary malignant bone tumor often requires a surgical treatment to remove the tumor and sometimes restore the anatomy using a frozen allograft. During the removal, there is a need for a highest possible accuracy to obtain a wide safe margin from the bone tumour. In case of reconstruction using a bone allograft, an intimate and precise contact at each host-graft junction must be obtained (Enneking 2001). The conventional freehand technique does not guarantee a wide safe margin nor a satisfying reconstruction (Cartiaux 2008). The emergence of navigation systems has procured a significant improvement in accuracy (Cartiaux 2010). However, their use implies some constraints that overcome their benefits, specifically for long bones. Patient-specific cutting guides become now available for a clinical use and drastically simplify the intra-operative set-up. We present the use of pre-operative assistances to produce patient-specific cutting guides for tumor resection and allograft adjustment. We also report their use in the operative room. We have developed technical tools to assist the surgeon during both pre-operative planning and surgery. First, the tumor extension is delineated on MRI images. These MRI images are then merged with Computed Tomography scans of the patient. The tumor and the CTscan are loaded in custom software that enables the surgeon to define target (desired) cutting planes around the tumor (Paul 2009) including a user-defined safe margin. Finally, cutting guides are designed on the virtual model of the patient as a mould of the bone surface surrounding the tumor, materialising the desired cutting planes. When required, a massive bone allograft is selected by comparing shapes of the considered patient's bone and available allografts. The resection planes are transferred onto the selected allograft and a second guide is designed for the allograft cutting. The virtually-designed cutting guides are then manufactured by a rapid prototyping machine using biocompatible material. This procedure has been used to excise a local recurrence of a tibial sarcoma and reconstruct the anatomy using a frozen tibial allograft. The pre-operative planning using virtual models of the patient's bone, tumor and the available allografts enabled the surgeon to localise the tumor, define the desired cutting planes and select the optimal allograft. Patient- and allograft-specific guides have been designed and manufactured. A stable and accurate positioning of guide onto the patient's tibia was made easier thanks to the plate formerly put in place during the previous surgery. An accurate positioning of the allograft cutting guide has been obtained thanks to its design. The obtained reconstruction was optimal with a adjusted allograft that was perfectly fitting the bone defect. The leg alignment was also optimally restored. Computer assistances for tumor surgery are progressively appearing. We have presented at CAOS 2010 an optical navigation system for tumor resection in the pelvis that was promising. However, such a tool is not well adapted for long bones. We have used patient-specific guides on a clinical case to assess the feasibility of the technique and check its accuracy in the resection and reconstruction. The surgeon has benefited from the 3D planning to define his strategy. He had the opportunity to select the optimal transplant for his patient and plan the same cuttings for the allograft and the patient. During the surgery, guide positioning was straightforward and accurate. The bone cuttings were very easy to perform. The use of custom guides decreases the operating time when compared to the conventional procedure since there is no need for measurements between cutting trajectories and anatomical landmarks. Furthermore, the same cutting planes were performed around the tumor and onto the allograft to obtain a transplant that optimally fills the defect. We recommend the use of such an intra-operative assistance for tumor surgery


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 29 - 29
1 Feb 2020
Abe I Shirai C
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Background. Accurate acetabular cup positioning is considered to be essential to prevent postoperative dislocation and improve the long-term outcome of total hip arthroplasty (THA). Recently various devices such as navigation systems and patient-specific guides have been used to ensure the accuracy of acetabular cup positioning. Objectives. The present study evaluated the usefulness of CT-based three-dimensional THA preoperative planning for acetabular cup positioning. Methods. This study included 120 hips aged mean 68.3 years, who underwent primary THA using CT-based THA preoperative planning software ZedHip® (LEXI, Tokyo Japan) and postoperative CT imaging (Fig.1). The surgical approach adopted the modified Watson-Jones approach in the lateral decubitus position and Trident HA acetabular cups were used for all cases. Preoperatively the optimum cup size and position in the acetabular were decided using the ZedHip® software, taking into consideration femoral anteversion and to achieve the maximum range of motion in dynamic motion simulation. Radiographic inclination (RI) was selected in the range between 40°∼45° and radiographic anteversion (RA) in the range between 5°∼25°. Three-dimensional planning images of the cup positioning were obtained from the ZedHip® software, and the distances between the edge of the implant and anatomical landmarks such as the edge of the anterior or superior acetabular wall were measured on the three-dimensional images and recorded (Fig.2). Intraoperatively, the RI and RA were confirmed by reference to these distances and the acetabular cup was inserted. Relative positional information of the implant was extracted from postoperative CT imaging using the ZedHip® software and used to reproduce the position of the implant on preoperative CT imaging with the software image matching function. The difference between the preoperative planning and the actual implant position was measured to assess the accuracy of acetabular cup positioning using the ZedHip® software. Results. Actual cup size corresponded with that of preoperative planning in 95% of cases (114 hips). Postoperative mean RI was 42.3° ± 4.2° (95% confidence interval (CI), 41.5° ∼ 43.0°) and mean RA was 16.1° ± 5.9° (95%CI, 15.0° ∼ 17.1°). Deviation from the target RI was 4.2° ± 3.7° (95%CI, 3.5° ∼ 4.9°) and deviation from the target RA was 4.0° ± 3.6° (95%CI, 3.4° ∼ 4.7°). Overall 116 hips (96.7%) were within the RI safe zone (30° ∼ 50°) and 108 hips (90.0%) were within the RA safe zone (5° ∼ 25°), and 105 hips (87.5%) were within both the RI and RA safe zones (Fig.3). Mean cup shift from preoperative planning was 0.0mm ± 3.0mm to the cranial side in the cranio-caudal direction, 2.1mm ± 3.0mm to the anterior side in the antero-posterior direction, and 1.7mm ± 2.1mm to the lateral side in the medio-lateral direction. Conclusion. The accuracy of acetabular cup positioning using our method of CT-based three-dimensional THA preoperative planning was slightly inferior to reported values for CT-based navigation, but obviously superior to those without navigation and similar to those with portable navigation. CT-based three-dimensional THA preoperative planning is effective for acetabular cup positioning, and has better cost performance than expensive CT-based navigation. For any figures or tables, please contact the authors directly


Introduction. Patient-specific cutting guides entered into clinical practice few years ago, first introduced in total knee replacement and recently also for other joint replacements. Advantages claimed are improving accuracy and repeatability in implant placement. New patient-specific guides to perform an accurate femoral neck resection and provide a precise alignment reference for acetabular reaming in total hip arthroplasty (THA) were recently developed by Medacta International: MyHip Technology. To date femoral guides can be designed for both anterior and posterior approaches, whereas acetabular guides are available only for posterior approach. Evaluation of the repeatability and reproducibility of MyHip guides placement on cadavers is performed using a navigation system. Accuracy of femoral MyHip guides is evaluated also through one author's clinical experience (RP). Materials and Methods. During each cadaveric session one body (2 hips) was available. A pre-operative CT scan has been obtained and used in order to create the 3D bone model of the pelvis and proximal femurs. Afterwards, a surgical planning for THA has been performed for each case, and, once it was approved by the surgeons, the designed patient-specific blocks were made. Intraobserver and interobserver agreement in positioning the guides was assessed getting measures of femoral head resection height (mm), femoral head plane inclination/anteversion (°) and acetabular reaming axis orientation (°). 9 surgeons, through 2 cadaveric sessions, positioned each guide, removed it and re-positioned it 5 times alternatively. The system is judged as accurate if all measures differ less than 3mm and 5°for lengths and angles respectively from the average among all the acquisitions. Clinical experience includes 68 THA which were performed between March 2014 and April 2015. Anterior femoral MyHip guides were used for the femoral head resection, while the acetabular side was prepared using the standard metal instrumentation for minimally invasive anterior approach. Intra-operative complications, as well post-operative leg length difference and implant positioning are assessed. Results. During cadaveric sessions, all measures taken meet the acceptance criteria with the exception of two measures, which are −5,98° and −5,57°, in femoral head plane anteversion and inclination respectively with femoral anterior guides. Looking at intraobserver variation, MyHip Femoral anterior guide positioning average deviation was between −0.91 mm and 1.44 mm (resection height), −1.25° and 1.41° (anteversion), and −0.85° and 0.82° (inclination); MyHip Femoral posterior guide positioning average deviation was between −0.47 mm and 0.67 mm (resection height), −1.33° and 1.50° (anteversion), −0.66° and 1.50° (inclination); MyHip Acetabular posterior guide had an average z-axis deviation from the mean value between −0.91° and 0.91°. All surgeries were successfully performed. The surgeon feels a good fitting and stability of the guide during each surgery. A preliminary analysis suggests optimal outcomes in terms of accurate prosthetic component positioning and reduction of occurrence of leg length inequality. Conclusion. Cadaveric sessions show intraobserver and intraobserver agreement, demonstrating reproducibility and repeatability in placement of MyHip patient specific cutting guides. Clinical experience confirms the advantages claimed by this technique, suggesting a possible reduction of complications usually linked to implant malpositioning, such as wear, impingement, risk of luxation


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%)


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 41 - 41
1 Dec 2013
D'Lima D Patil S Bunn A Bugbee W Colwell C
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Introduction:. Despite over 95% long-term survivorship of TKA, 14–39% of patients express dissatisfaction due to anterior knee pain, mid-flexion instability, reduction in range of flexion, and incomplete return of function. Changing demographics with higher expectations are leading to renewed interest in patient-specific designs with the goal of restoring of normal kinematics. Improved imaging and image-processing technology coupled with rapid prototyping allow manufacturing of patient-specific cutting guides with individualized femoral and tibial components with articulating surfaces that maximize bony coverage and more closely approximate the natural anatomy. We hypothesized that restoring the articular surface and maintaining medial and lateral condylar offset of the implanted knee to that of the joint before implantation would restore normal knee kinematics. To test this hypothesis we recorded kinematics of patient-specific prostheses implanted using patient-specific cutting guides. Methods:. Preoperative CT scans were obtained from nine matched pairs of human cadaveric knees. One of each pair was randomly assigned to one of two groups: one group implanted with a standard off-the-shelf posterior cruciate-retaining design using standard cutting guides based on intramedullary alignment; the contralateral knee implanted with patient-specific implants using patient-specific cutting guides, both manufactured from the preoperative CT scans. Each knee was tested preoperatively as an intact, normal knee, by mounting the knee on a dynamic, quadriceps-driven, closed-kinetic-chain Oxford knee rig (OKR), simulating a deep knee bend from 0° to 120° flexion. Following implantation with either the standard or patient-specific implant, knees were mounted on the OKR and retested. Femoral rollback, tibiofemoral rotation, tibial adduction, patellofemoral tilt and shift were recorded using an active infrared tracking system. Results:. To reduce the effect of variability, change in each kinematic measure was quantified as the absolute difference between the normal kinematic measure and the same measure after implantation (10° flexion increments). The cumulative difference from normal kinematics was calculated by summing the area beneath the curve (Fig 2). Cumulative differences in kinematics from normal were statistically lower for the patient-specific group compared to the standard group for all measures except patellar shift (Fig 2, paired t-test). Discussion:. Knee kinematics with the patient-specific design more closely approximated normal femoral rollback and tibial adduction than knees with the standard design. Femoral rollback is significantly closer qualitatively and quantitatively to normal in specimens implanted with patient-specific designs (Figs 1). The tibia rotated internally with flexion; however, the patient-specific group more closely approximated normal rotation. The patient-specific group more closely approximated normal tibial adduction suggesting ligament balance was better restored. Due to substantial differences in articular morphology among genders, races and patients, it is impossible to provide multiple sized implants to address the full range of inter-patient variability. Patient-specific designs that remove this variation, restore normal articular geometry, and maintain alignment are more likely to result in normal kinematics. Our results support the hypothesis that knees with patient-specific implants generate kinematics more closely resembling normal knee kinematics than standard knee designs. Clinical outcome studies are necessary to determine if our results translate into better outcomes


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