CT-based Patient-specific Instrumentation Research Articles

Computed tomography-based patient-specific cutting guides used for positioning of the femoral component of implants during unicompartmental knee arthroplasty: a cadaver study

BackgroundTo investigate whether patient-specific instrumentation (PSI) improves the femoral component positioning of implants during unicompartmental knee arthroplasty (UKA) using cadaver bone models.MethodsFifty adult cadaveric femoral bone specimens collected from February 2016–2018, were randomized to receive medial UKA with a PSI guide (n = 25) or conventional instrumentation (CI) (n = 25). Standard anteroposterior and lateral view radiographs were obtained postoperatively to assess the coronal and sagittal positioning of the femoral prostheses, respectively. The osteotomy time was recorded to assess the convenience of PSI in guiding osteotomy.ResultsOsteotomy time significantly shortened in the PSI group (3.12 ± 0.65 versus 4.33 ± 0.73 min, p < 0.001). There was a significant difference in the postoperative coronal alignment of the femoral component between the PSI and CI groups (varus/valgus angle: 1.43 ± 0.93° vs. 2.65 ± 1.50°, p = 0.001). The prevalence of outliers in coronal alignment was lower in the PSI than the CI group (2/25, 8% vs. 9/25, 36%). Sagittal posterior slope angle of the femoral component was significantly different between the two groups (8.80 ± 0.65° and 6.29 ± 1.88° in the CI and PSI groups, respectively, p < 0.001). The malalignment rate of the femoral component in the sagittal plane was 60% in the CI group, whereas no positioning deviation was observed in the PSI group.ConclusionThis study used a cadaver model to support the fact that CT-based PSI shows an advantage over CI in optimizing implant positioning for UKAs.

Evaluation of the accuracy of resected bone thickness based on patient-specific instrumentation during total knee arthroplasty.

In total knee arthroplasty (TKA) using patient-specific instrumentation (PSI), the correlation between the preoperative surgical plan and intraoperative resection size is unclear. The aims of this study were to evaluate whether the computed tomography (CT)-based PSI surgical plan can be executed accurately and to determine the accuracy of bone resection in TKA using PSI. Data of 45 consecutive knees undergoing TKA using CT-based PSI were retrospectively evaluated. The preoperative plan was prepared using three-dimensional CT acquisitions of the hip, knee, and ankle joints. Resected bone thicknesses of the femoral condyle of the distal medial, distal lateral, posterior medial, posterior lateral, and medial and lateral tibial plateaus were measured with a Vernier caliper intraoperatively. Then these respective measurements were compared with those in the preoperative CT-predicted bone resection surgical plan, and the measured thickness of resection was subtracted from the planned resection thickness. Errors were defined as: acceptable, ≤ 1.5mm; borderline, 1.5-2.5mm; and outliers, > 2.5mm. Overall, 22 (48.9%) knees had no outliers. There were 20 (44.4%) and 3 (6.7%) knees in which only 1 and 2 resection planes were outliers, respectively. The posterior medial tibial plateau had the lowest proportion of acceptable cuts (44.4%). Posterior femoral resection including the medial and lateral condyles had more outliers (n = 18/90 cuts, 20.0%) (p < 0.001) than the tibial condyles (n = 3/90 cuts, 3.3%) and distal femoral cuts (n = 6/90 cuts, 6.7%). The posterior surface of the femur, where the incidence of outliers was higher, tended to have a higher proportion of undercuts than other surfaces of the femur (> 80%). PSI showed only fair-to-moderate accuracy. The cutting guide for the posterior femur was less accurate than that for the tibia and distal femur. Specific attention is required when cutting the posterior femur. The PSI design needs to be improved to reduce errors.

Short-Term Results of Patient Specific Instruments (PSI) – Total Knee Replacement (TKR)

Background: TKR is an effective treatment for severely arthritic knees. PSI TKR is a recent technique, which relies on preoperative formulation of specific instruments for every patient preoperatively, aiming at decreasing surgical time and instruments and increasing accuracy and functional outcome. Objective: Assessment of functional and radiological outcome of PSI TKR after a period of 3 years duration. Patients and Methods: 40 TKRs in 24 patients were done using CT-based PSI technique. Pre-and postoperative knee society score (KSS) were measured and digital long-leg X-rays were obtained for all patients. Hip-knee-ankle, proximal tibia land lateral distal femoral angles together with mechanical axis deviation were measured for all patients to assess the mechanical axis alignment after TKR. Results: HKA (hip knee ankle) has decreased from 4.70 varus preoperatively to 1.27 varus. The mean knee society score had markedly increased from 31.2 preoperatively to 85.3 with fair to excellent KSS was 95% after 3 years duration. Conclusion: PSI TKR is an effective technique in knee replacement as conventional method. With the advantages of reduction of the operative steps and concurrent potential complications.

CT-based patient-specific instrumentation for total knee arthroplasty in over 700 cases: single-use instruments are as accurate as standard instruments

PurposeEfforts in total knee arthroplasty are made to improve accuracy for a correct leg axis and reduce component malpositioning using patient-specific instruments. It was hypothesized that use of patient-specific instruments (vs. computer-navigated and conventional techniques) will reduce the number of outliers. Our second hypothesis was that single-use instrumentation will lead to the same accuracy compared to patient-specific instruments made of metal.Methods708 primary total knee arthroplasties between 2014 and 2018 using computer tomography (CT)-based patient-specific cutting block technique and a preoperative planning protocol were retrospectively reviewed. Preoperative data [hip–knee–angle (HKA), lateral distal femoral angle (LDFA), medial proximal tibial angle (MPTA), tibial slope, femoral component flexion] was compared to postoperative performed standard radiological follow-up X-rays. Differences of > 3° between measurements were defined as outliers.ResultsOverall 500 prostheses using standard instrumentation and 208 prostheses using single-use instruments were implanted. Preoperative HKA axes (− 1.2°; p < 0.001), femoral component flexion (Δ 0.8°, p < 0.001), LDFA (Δ − 1.5°, p < 0.001), MPTA (Δ − 0.5°, p < 0.001) and tibial posterior slopes (Δ 0.5°, p < 0.001), respectively, were different from postoperative axes. More outliers occurred using standard (vs. single-use) instruments (p < 0.001) regarding postoperative HKA (ranges of standard- vs. single-use: instruments: HKA 178.0°–180.5° vs. 178.0°–180.5°, femoral component flexion 0.0°–6.0° vs. 0.0°–4.5°, LDFA 90.0°–91.0° vs. 90.0°–90.0°, MPTA 90.0°–90.0° vs. 90.0°–90.0°, tibial posterior slope − 10° to 10° vs. − 1° to 10°). No differences were seen for other angles measured. Comparing both systems, total number of outliers was higher using standard (8%) vs. single-use instruments (4.3%).ConclusionThis study shows a high accuracy of CT-based patient-specific instrumentation concerning postoperative achieved knee angles and mechanical leg axes. Single-use instruments showed a similar accuracy.Level of evidenceIII.

Patient-Specific or Conventional Instrumentations: A Meta-analysis of Randomized Controlled Trials.

Objective To conduct a meta-analysis of randomized controlled trials (RCTs) to compare knee arthroplasty with patient-specific instrumentation (PSI) with the conventional instrumentation (CI). Methods RCTs were selected in PubMed and Embase from 2012 to 2018. Key data extracted included malalignment of mechanical axis, blood loss, surgical time, Oxford Knee Score (OKS), Knee Society Score (KSS), length of stay, and complications. Subgroup analysis was also performed regarding different PSI systems and different image processing methods. Results 29 RCTs with 2487 knees were eligible for the meta-analysis. Results showed that PSI did not improve the alignment of the mechanical axis compared with CI, but MRI-based PSI and Visionaire-specific PSI decrease the risk of malalignment significantly (P = 0.04 and P = 0.04 and P = 0.04 and P = 0.04 and P = 0.04 and Conclusion PSI reduced the blood loss and improved KSS. MRI-based PSI reduced operative time and risk of malalignment of mechanical axis compared with CT-based PSI. Moreover, Visionaire-specific PSI achieves better alignment result of the mechanical axis than other systems.

MRI-based or CT-based patient-specific instrumentation in Total knee Arthroplasty: How do the two systems compare?

BackgroundPatient-specific instrumentation (PSI) has been introduced into total knee arthroplasty (TKA) to improve accuracy in restoration of alignment. PSI in TKA refers to custom-made cutting jigs manufactured according to anatomic configuration of the patient’s bone based on preoperative magnetic resonance imaging (MRI) or computed tomography (CT) scans. The purpose of this study was to compare the MRI- or CT-based PSI to see if they could reproduce accurate bone resection and postoperative outcomes.MethodsSeventy-one patients who received elective TKA using a PSI system for primary osteoarthritis with varus deformity were prospectively enrolled for this study. We randomly allocated those patients to MRI-based PSI group (36 patients) and CT-based PSI group (35 patients). The actual resection thickness and planned resection thickness by preoperative PSI electronic program were compared between the two groups. Radiographic findings of the postoperative limb alignment, three-dimensional position of the implants, and related complications were also evaluated. Clinical evaluation was also performed before and 2 years after the surgery.ResultsThere were no significant differences in the resection thickness in femur and tibia between actual resection and planned resection in both groups. Furthermore, there were no significant differences between two groups in terms of coronal, sagittal and rotational alignment of the components. All clinical assessments revealed no differences between two groups 2 years after the operation. No specific complication related to PSI was observed.ConclusionsAlthough MRI allows for visualization of cartilage, MRI-based PSI system did not show better accuracy in predicting the thickness of bone resection than CT-based PSI. Moreover, there were no differences in radiographic and clinical outcomes between the two groups.

Fewer femoral rotational outliers produced with CT- than with MRI-based patient-specific instrumentation in total knee arthroplasty.

Previous studies comparing the surgical accuracy between computed tomography (CT)- and magnetic resonance imaging (MRI)-based patient-specific instrumentation (PSI) methods have produced contradictory results. The aim of this study was to determine which is the more reliable imaging method (CT versus MRI) for patient-specific total knee arthroplasty (TKA). CT-based PSI is hypothesised to have an advantage regarding the number of outliers. A total of 22 randomised controlled trials (RCTs), including 1749 TKA cases, were eligible for the meta-analysis. RCTs, systematic reviews and meta-analyses on this topic published in databases before September 2018 were identified by a literature search. The primary outcome was the number of lower extremities with greater than 3° of difference in alignment angles between the postoperative outcomes and target outcomes. The parameters calculated from the meta-analysis included risk ratios (RRs) and 95% confidence intervals (CIs). Additionally, the publication bias and heterogeneity of the studies were assessed. The risk of femoral rotational outliers in the PSI group (RR = 0.48; 95% CI 0.24-0.98) was significantly reduced. Furthermore, subgroup analysis showed that the accuracy in the CT-based PSI group was significantly higher than that in the MRI-based CSI group (RR = 0.31; 95% CI 0.10-0.92). This meta-analysis shows that when performing TKA with PSI, preoperative CT is beneficial for the production of the PSI, resulting in a significantly lower proportion of outliers in femoral rotational alignment. CT should be the preferred choice for imaging when performing TKA surgery with PSI to obtain better femoral rotational alignment. Therapeutic study (systematic review and meta-analysis), Level I.

Planning on CT-Based 3D Virtual Models Can Accurately Predict the Component Size for Total Knee Arthroplasty.

The ability to predict accurate sizing of the implant components for total knee arthroplasty surgery can have several benefits in the operating room, in terms of simplifying the workflow and reducing the number of required instrument trays. Planning on a three-dimensional (3D) virtual model can be used to predict size. The aim of this study was to quantify the accuracy of the surgeon-validated plan prediction on a computed tomography (CT)-based system. The clinical records of 336 cases (267 patients), operated using a CT-based patient-specific instrumentation, have been reviewed for the size of implanted components. Preoperative default planning (according to the preferences of the surgeon) and approved planning have been compared with the size of implanted components for both the femur and tibia. The prosthesis size, preplanned by the manufacturers, was modified by the surgeon during the validation process in 0.9% of cases for the femoral component and in 2.7% of cases for the tibial component. The prosthesis size, preplanned by the surgeon after the validation process, was used in 95.8% for the femur and 92.6% for the tibia. Concordance on the size of the surgeon-validated plan and the finally implanted size was perfect for both, the femoral (κ = 0.951; 95% confidence interval [CI]: 0.92-0.98) and the tibial component (κ = 0.902; 95% CI: 0.86-0.94). The most frequent change of size (51%) was an increase by one size of the planned tibial component. Planning of knee arthroplasty surgery on a 3D virtual, CT-based model is useful to surgeons to help predict the size of the implants to be used in surgery. The system we have used can accurately predict the component size for both the femur and tibia. This study reflects a study of level III evidence.

Significant differences between manufacturer and surgeon in the accuracy of final component size prediction with CT-based patient-specific instrumentation for total knee arthroplasty.

Patient-specific instrumentation (PSI) for total knee arthroplasty (TKA) may improve component sizing. Little has been reported about accuracy of the default plan created by the manufacturer, especially for CT-based PSI. The goal of this study was to evaluate the reliability of this plan and the impact of the surgeon's changes on the final accuracy of the guide sizes. Forty-five patients eligible for primary TKA were prospectively enrolled. The planned implant sizes were prospectively recorded from the initial manufacturer's proposal and from the final plan adjusted in light of the surgeon's evaluation; these two sizes where then compared to the actually implanted sizes. Fisher's exact test was used to test differences for categorical variables. Agreement between pre-operative plans and final implant was evaluated with the Bland-Altman method. The manufacturer's proposal differed from the final implant in 9 (20.0%) femoral and 23 (51.1%) tibial components, while the surgeon's plan in 6 (13.3%, femoral) and 12 (26.7%, tibial). Modifications in the pre-operative plan were carried out for five (11.1%) femoral and 23 (51.1%) tibial components (p = 0.03). Appropriate modification occurred in 22 (88.0%) and 19 (76.0%) cases of femoral and tibial changes. The agreement between the manufacturer's and the surgeon's pre-operative plans was poor, especially with regard to tibial components. The surgeon's accuracy in predicting the final component size was significantly different from that of the manufacturer and changes in the initial manufacturer's plan were necessary to get an accurate pre-operative plan of the implant sizes. Careful evaluation of the initial manufacturer's plan by an experienced knee surgeon is mandatory when planning TKA with CT-based PSI. II.

Revision of partial knee to total knee arthroplasty with use of patient-specific instruments results in acceptable femoral rotation.

Patient-specific instruments (PSI) were initially developed for the alignment of both total knee- (TKA) and partial knee arthroplasty (PKA). We hypothesize that CT-based PSI for PKA-to-TKA revision surgery can restore biomechanical limb alignment and prosthetic component positioning in vivo as calculated pre-operatively, resulting in a limited percentages of outliers. An imaging analysis was performed using CT-based 3D measurement methods based on a pre- and post-revision CT scan. Imaging data were gathered on 10 patients who were operated for PKA-to-TKA revision with the use of PSI based on CT imaging. The planned femur and tibia component position in vivo were compared with the pre-revision planned component position. Outliers were defined as deviations >3.0° from pre-revision planned position for the individual implant components. Adjustments (e.g. resection level and implant size) during surgery were recorded. The HKA axis was restored accurately in all patients with a mean post-operative HKA axis of 178.1° (1.4°). Five femoral (2 varus, 2 internal rotation and 1 extension) and 14 tibial guides (2 varus, 6 anterior slope, 3 internal rotation and 3 external rotation) on a total of 60 outcome measures were identified as outliers. During surgery, an intraoperative tibial resection of 2mm extra was performed in three patients. In 80 and 70% for, respectively, the femur and tibia, the surgeon-planned size was implanted during surgery. All patient-specific guides fitted well in all patients. No intraoperative or post-operative complications related to surgery were registered. This study introduced a unique new concept regarding PSI, PKA-to-TKA revision surgery. Based on the results, we were unable to fully confirm our hypothesis. PSI as a "new" tool for PKA-to-TKA revision surgery appears to be an accurate tool for the alignment of the TKA femur component. The tibial guide seems more susceptible to errors, resulting in a substantial percentage of outliers. Prospective cohort study, Level II.

Favourable alignment outcomes with MRI-based patient-specific instruments in total knee arthroplasty.

Patient-specific instruments (PSIs) are already in relatively common use, and their post-operative radiographic results are equal to those for total knee arthroplasty (TKA) with conventional instrumentation. PSI use requires a preoperative MRI scan, CT scan, or a combination of MRI and a long-leg standing radiograph. However, there is no consensus as to which of these modalities, MRI or CT, is the preferred imaging modality when performing TKA with PSIs. This systematic literature review and meta-analysis studied the differences in alignment outliers between CT- and MRI-based PSI for TKA. A search of the Cochrane Database of Systematic Reviews, MEDLINE/PubMed and Embase was conducted, without restriction on date of publication. Only level I evidence studies written in English that included TKA with the use of MRI- and CT-based PSI were selected. A meta-analysis was then performed of the rate of outliers in the biomechanical axis and individual femoral and tibial component alignment. Where considerable heterogeneity among studies was present or the data did not provide sufficient information for performing the meta-analysis, a qualitative synthesis was undertaken. Twelve randomized controlled trials, studying 841 knees, were eligible for data extraction and meta-analysis. MRI-based PSI resulted in a significantly lower proportion of coronal plane outliers with regard to the lateral femoral component (OR 0.52, 95% CI 0.30-0.89, P=0.02), without significant heterogeneity (n.s.). There were no significant differences regarding the biomechanical axis or frontal femoral and individual tibial component alignment. This systematic review and meta-analysis demonstrate that alignment with MRI-based PSI is at least as good as, if not better than, that with CT-based PSI. To prevent for malalignment, MRI should be the imaging modality of choice when performing TKA surgery with PSI. I.

Novel alignment measurement technique for total knee arthroplasty using patient specific instrumentation.

This study was designed to evaluate the true accuracy of patient specific instrumentation (PSI) for total knee arthroplasty (TKA) using a new 3D measurement method. Consecutive 21 patients (30 knees) who underwent TKA using computed tomography (CT)-based PSI were retrospectively evaluated. Mean patient age was 69.2years (62 to 77). The postoperative three-dimensional (3D) CT image were superimposed onto the preoperative 3D CT plan and measured the absolute difference in the prosthetic alignment using six parameters: coronal, sagittal, and axial alignment of the femoral and tibial prostheses. Cases in which the difference in the prosthetic alignment was greater than 3° were considered outliers. For the femoral prosthesis, mean absolute differences between the preoperative 3D CT plan and postoperative 3D CT image were not significantly different and the rates of outliers were 10.0, 33.3, 23.3% in the coronal, sagittal, and axial planes. For the tibial prosthesis, mean absolute differences were significantly larger in the axial plane than in the coronal and sagittal planes (p < 0.001) and the rates of outliers were 23.3, 36.7, 63.3% in the coronal, sagittal, and axial planes. The rates of outliers for the axial alignment of tibial prosthesis were significantly higher than for the other five planes (p = 0.006). The rotation of the tibial prosthesis with CT-based PSI was less accurate in the axial plane than in the other five planes.

Patient-specific instrumentation for total knee arthroplasty.

To assess the accuracy of total knee replacements (TKRs) performed using CT-based patient-specific instrumentation by postoperative CT scan. Approval from the Ethics Committee was granted prior to commencement of this study. Fifty prospective and consecutive patients who had undergone TKR (Evolis, Medacta International) using CT-based patient-specific instrumentation (MY KNEE, Medacta International) were assessed postoperatively using a CT scan and the validated Perth protocol measurement technique. The hip-knee-ankle (HKA) angle of the lower limb in the coronal plane; the coronal, sagittal, and rotational orientation of the femoral component; and the coronal and sagittal orientation of the tibial component were measured. These results were then compared to each patient's preoperative planning. The percentage of patients found to be less than or equal to 3° of planned alignment was calculated. One patient was excluded as the femoral cutting block did not fit the femur as predicted by planning and therefore underwent a conventional TKR. Ninety-eight percent of patients were within 3° of planned alignment in the coronal plane reproducing the predicted HKA angle. Predicted coronal plane orientation of the tibial and femoral component was achieved in 100% and 96% of patients, respectively. The sagittal orientation of the femoral component was within 3° in 98% of patients. The planned sagittal positioning of the tibial component was achieved in 92% of patients. Furthermore, 90% of patients were found to have a femoral rotation within 3° of planning. Eighty-six percent of patients achieved good-to-excellent outcome at 12 months (Oxford Knee Score > 34). We have found that TKR using this patient-specific instrumentation accurately reproduces preoperative planning in all six of the parameters measured in this study.

Outcomes following total knee arthroplasty with CT-based patient-specific instrumentation.

A 24-month prospective follow-up study was carried out to compare perioperative clinical outcomes, radiographic limb alignment, component positioning, as well as functional outcomes following total knee arthroplasty (TKA) between patient-specific instrumentation (PSI) and conventional instrumentation (CI). Ninety consecutive patients, satisfying the inclusion and exclusion criteria, were scheduled to undergo TKA with either PSI or CI. A CT-based PSI was used in this study, and a senior surgeon performed all surgeries. Patients were clinically and functionally assessed preoperatively, 6 and 24months post-operatively. Perioperative outcomes were also analysed, including operating time, haemoglobin loss, the need for blood transfusion, length of hospitalisation, and radiographic features. At 24-month follow-up, clinical and functional outcomes were comparable between the two groups. PSI performed no better than CI in restoring lower limb mechanical alignment or improving component positioning. There were no differences in operating time, haemoglobin loss, transfusion rate, or length of hospitalisation between PSI and CI. No significant clinical benefit could be demonstrated in using PSI over CI after 24months, and routine use of PSI is not recommended in non-complicated TKA. II.

Computerised tomography vs magnetic resonance imaging for modeling of patient-specific instrumentation in total knee arthroplasty.

To summarise and compare currently available evidence regarding accuracy of pre-operative imaging, which is one of the key choices for surgeons contemplating patient-specific instrumentation (PSI) surgery. The MEDLINE and EMBASE medical literature databases were searched, from January 1990 to December 2013, to identify relevant studies. The data from several clinical studies was assimilated to allow appreciation and comparison of the accuracy of each modality. The overall accuracy of each modality was calculated as proportion of outliers > 3% in the coronal plane of both computerised tomography (CT) or magnetic resonance imaging (MRI). Seven clinical studies matched our inclusion criteria for comparison and were included in our study for statistical analysis. Three of these reported series using MRI and four with CT. Overall percentage of outliers > 3% in patients with CT-based PSI systems was 12.5% vs 16.9% for MRI-based systems. These results were not statistically significant. Although many studies have been undertaken to determine the ideal pre-operative imaging modality, conclusions remain speculative in the absence of long term data. Ultimately, information regarding accuracy of CT and MRI will be the main determining factor. Increased accuracy of pre-operative imaging could result in longer-term savings, and reduced accumulated dose of radiation by eliminating the need for post-operative imaging and revision surgery.

Patient-specific instrumentation improved mechanical alignment, while early clinical outcome was comparable to conventional instrumentation in TKA.

The aim of this prospective study was to compare early clinical outcome, radiological limb alignment, and three-dimensional (3D)-component positioning between conventional and computed tomography (CT)-based patient-specific instrumentation (PSI) in primary mobile-bearing total knee arthroplasty (TKA). Two hundred ninety consecutive patients (300 knees) with severe, debilitating osteoarthritis scheduled for TKA were included in this study using either conventional instrumentation (CVI, n = 150) or PSI (n = 150). Patients were clinically assessed before and 2 years after surgery according to the Knee-Society-Score (KSS) and the visual-analog-scale for pain (VAS). Additionally, the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) and the Oxford-Knee-Score (OKS) were collected at follow-up. To evaluate accuracy of CVI and PSI, hip-knee-ankle angle (HKA) and 3D-component positioning were assessed on postoperative radiographs and CT. Data of 222 knees (CVI: n = 108, PSI: n = 114) were available for analysis after a mean follow-up of 28.6 ± 5.2 months. At the early follow-up, clinical outcome (KSS, VAS, WOMAC, OKS) was comparable between the two groups. Mean HKA-deviation from the targeted neutral mechanical axis (CVI: 2.2° ± 1.7°; PSI: 1.5° ± 1.4°; p < 0.001), rates of outliers (CVI: 22.2%; PSI: 9.6%; p = 0.016), and 3D-component positioning outliers were significantly lower in the PSI group. Non-outliers (HKA: 180° ± 3°) showed better clinical results than outliers at the 2-year follow-up. CT-based PSI compared with CVI improves accuracy of mechanical alignment restoration and 3D-component positioning in primary TKA. While clinical outcome was comparable between the two instrumentation groups at early follow-up, significantly inferior outcome was detected in the subgroup of HKA-outliers. Prospective comparative study, Level II.

Editor's Spotlight/Take 5: Small improvements in mechanical axis alignment achieved with MRI versus CT-based patient-specific instruments in TKA: a randomized clinical trial.

Note from the Editor-In-Chief: In “Editor’s Spotlight,” one of our editors provides brief commentary on a paper we believe is especially important and worthy of general interest. Following the explanation of our choice, we present “Take Five,” in which the editor goes behind the discovery with a one-on-one interview with an author of the article featured in “Editor’s Spotlight.” The authors certify that they, or any members of their immediate family, have no commercial associations (eg, consultancies, stock ownership, equity interest, patent/licensing arrangements, etc) that might pose a conflict of interest in connection with the submitted article. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research ® editors and board members are on file with the publication and can be viewed on request. The opinions expressed are those of the writers, and do not reflect the opinion or policy of CORR ® or the Association of Bone and Joint Surgeons®. This comment refers to the article available at: 10.1007/s11999-014-3784-6.

Small Improvements in Mechanical Axis Alignment Achieved With MRI versus CT-based Patient-specific Instruments in TKA: A Randomized Clinical Trial

Patient-specific instrumentation in TKA has the proposed benefits of improving coronal and sagittal alignment and rotation of the components. In contrast, the literature is inconsistent if the use of patient-specific instrumentation improves alignment in comparison to conventional instrumentation. Depending on the manufacturer, patient-specific instrumentation is based on either MRI or CT scans. However, it is unknown whether one patient-specific instrumentation approach is more accurate than the other and if there is a potential benefit in terms of reduction of duration of surgery. We compared the accuracy of MRI- and CT-based patient-specific instrumentation with conventional instrumentation and with each other in TKAs. The three approaches also were compared with respect to validated outcomes scores and duration of surgery. A randomized clinical trial was conducted in which 90 patients were enrolled and divided into three groups: CT-based, MRI-based patient-specific instrumentation, and conventional instrumentation. The groups were not different regarding age, male/female sex distribution, and BMI. In all groups, coronal and sagittal alignments were measured on postoperative standing long-leg and lateral radiographs. Component rotation was measured on CT scans. Clinical outcomes (Knee Society and WOMAC scores) were evaluated preoperatively and at a mean of 3 months postoperatively and the duration of surgery was analyzed for each patient. MRI- and CT-based patient-specific instrumentation groups were first compared with conventional instrumentation, the patient-specific instrumentation groups were compared with each other, and all three approaches were compared for clinical outcome measures and duration of surgery. Compared with conventional instrumentation MRI- and CT-based patient-specific instrumentation showed higher accuracy regarding the coronal limb axis (MRI versus conventional, 1.0° [range, 0°-4°] versus 4.5° [range, 0°-8°], p < 0.001; CT versus conventional, 3.0° [range, 0°-5°] versus 4.5° [range, 0°-8°], p = 0.02), femoral rotation (MRI versus conventional, 1.0° [range, 0°-2°] versus 4.0° [range, 1°-7°], p < 0.001; CT versus conventional, 1.0° [range, 0°-2°] versus 4.0° [range, 1°-7°], p < 0.001), and tibial slope (MRI versus conventional, 1.0° [range, 0°-2°] versus 3.5° [range, 1°-7°], p < 0.001; CT versus conventional, 1.0° [range, 0°-2°] versus 3.5° [range, 1°-7°], p < 0.001), but the differences were small. Furthermore, MRI-based patient-specific instrumentation showed a smaller deviation in the postoperative coronal mechanical limb axis compared with CT-based patient-specific instrumentation (MRI versus CT, 1.0° [range, 0°-4°] versus 3.0° [range, 0°-5°], p = 0.03), while there was no difference in femoral rotation or tibial slope. Although there was a significant reduction of the duration of surgery in both patient-specific instrumentation groups in comparison to conventional instrumentation (MRI versus conventional, 58 minutes [range, 53-67 minutes] versus 76 minutes [range, 57-83 minutes], p < 0.001; CT versus conventional, 63 minutes [range, 59-69 minutes] versus 76 minutes [range, 57-83 minutes], p < .001), there were no differences in the postoperative Knee Society pain and function and WOMAC scores among the groups. Although this study supports that patient-specific instrumentation increased accuracy compared with conventional instrumentation and that MRI-based patient-specific instrumentation is more accurate compared with CT-based patient-specific instrumentation regarding coronal mechanical limb axis, differences are only subtle and of questionable clinical relevance. Because there are no differences in the long-term clinical outcome or survivorship yet available, the widespread use of this technique cannot be recommended.

Patient-specific computed tomography based instrumentation in total knee arthroplasty: a prospective randomized controlled study.

The aim of this study was to compare radiological results of total knee arthroplasties (TKAs) performed with patient-specific computed tomography (CT)-based instrumentation and conventional technique. The main study hypothesis was that CT-based patient-specific instrumentation (PSI) increases the accuracy of TKA. A prospective, randomized controlled trial was carried out between January and December 2011. A group of 112 patients who met the inclusion and exclusion criteria were enrolled in this study and randomly assigned to an experimental or control group. The experimental group comprised 52 patients operated on with the aid of the Signature CT-based implant positioning system. The control group consisted of 60 patients operated on using conventional instrumentation. The radiographic evaluation of implant positioning and overall coronal alignment was performed 12 months after the surgery by using standing anteroposterior radiographs of the entire lower limb and standard lateral radiographs. Of the 112 patients initially enrolled for the study, 95 were included in the subsequent analyses. There were no statistically significant differences between groups in respect to coronal and sagittal component positioning and overall coronal alignment, except for frontal tibial component positioning. For this parameter, better results were obtained in the control group, with borderline statistical significance. Our study did not reveal superiority of the CT-based PSI system over conventional instrumentation. Further high-quality investigations of patient-specific systems are absolutely indispensable to assess their utility for TKA. In our opinion, the surgeon applying PSI technology is required to have advanced knowledge and considerable experience with the conventional method.

Rotational alignment of the distal femur: anthropometric measurements with CT-based patient-specific instruments planning show high variability of the posterior condylar angle.

Finding the anatomical landmarks used for correct femoral axial alignment can be difficult. The posterior condylar line (PCL) is probably the easiest to find during surgery. The aim of this study was to analyse whether a predetermined fixed angle referencing of the PCL could help find the surgical epicondylar axis (SEA) and this based on a large CT database with enough Caucasian diversity to be representable. A total of 2,637 CT scans and 3D reconstructions from patients on four continents, executed for preoperative planning and creation of patient-specific instrumentation, were used to perform anthropometric measurements and to measure the posterior condylar angle (PCA) between the surgical epicondylar angle and the PCL. The mean (SD) PCA was 4° (1.4°) of external rotation. A significant correlation was found between more external rotation of the SEA and more proximal varus of the tibia or more distal valgus of the femur. For 59% of the study population, 4° external rotation from the PCL would be the right amount of axial rotation to align the femoral component in line with the SEA. Nine per cent needs less, and 32% needs more than 4° of axial rotation. On 105 (4%) CT-based 3D models, external rotation between 7° and 11° was measured and 77 (73%) of those cases were in varus or neutral alignment. In 132 patients, bilateral measurements were available and 94 (71%) had rotation within 1° of the opposite side. This last finding underlines that there is even an intra-individual difference in distal femoral anatomy that can range from 1° to 5°. This study was performed on a very large anthropometric CT and 3D models database and showed that there is a 41% risk of malalignment if a fixed PCA referenced of the PCL is used in total knee arthroplasty. The clinical importance of this study is the observation that femoral axial anatomy is individual and also that it is determined by the tibial anatomy. A group of patients needs more than the average external rotation because they have more distal femoral valgus with dysplastic condyles or more proximal tibial varus with a bigger medial condyle. III.