title: Accuracy and efficacy of osteotomy in total knee arthroplasty with patient-specific navigational template. Patient-specific instrumentation improves tibial component rotation in TKA Rotation in total knee arthroplasty: no difference between patient-specific and conventional instrumentation No radiological and clinical advantages with patient-specific positioning guides in total knee replacement Patient-specific Guides Do Not Improve Accuracy in Total Knee Arthroplasty: A Prospective Randomized Controlled Trial Component alignment during total knee arthroplasty with use of standard or custom instrumentation: a randomized clinical trial using computed tomography for postoperative alignment measurement. Patient-Specific CT-Based Instrumentation versus Conventional Instrumentation in Total Knee Arthroplasty: A Prospective Randomized Controlled Study on Clinical Outcomes and In-Hospital Data Improved alignment and operating room efficiency with patient-specific instrumentation for TKA. No improvement in reducing outliers in coronal axis alignment with patient-specific instrumentation Patient-specific instrumentation in total knee arthroplasty: simpler, faster and more accurate than standard instrumentation—a randomized controlled trial No difference in clinical outcome between patient-matched positioning guides and conventional instrumented total knee arthroplasty two years post-operatively: a multicentre, double-blind, randomised controlled trial. Patient-matched instruments versus standard instrumentation in total knee arthroplasty: a prospective randomized study Intra-operative results and radiological outcome of conventional and patient-specific surgery in total knee arthroplasty: a multicentre, randomised controlled trial Stability and alignment do not improve by using patient-specific instrumentation in total knee arthroplasty: a randomized controlled trial Patient-specific instrumentation does not shorten surgical time: a prospective, randomized trial. Patient-specific instrumentation improved mechanical alignment, while early clinical outcome was comparable to conventional instrumentation in TKA Custom-fit minimally invasive total knee arthroplasty: effect on blood loss and early clinical outcomes Component alignment and clinical outcome following total knee arthroplasty: a randomised controlled trial comparing an intramedullary alignment system with patient-specific instrumentation. Accuracy of manual instrumentation of tibial cutting guide in total knee arthroplasty Comparison between patient-specific instruments and conventional instruments and computer navigation in total knee arthroplasty: a randomized controlled trial Contribution of patient-specific cutting guides to lower limb alignment for total knee arthroplasty. Patient-specific computed tomography based instrumentation in total knee arthroplasty: a prospective randomized controlled study Rotational alignment of femoral component between custom cutting block and conventional technique in total knee arthroplasty. A comparison of patient-specific and conventional instrumentation for total knee arthroplasty: a multicentre randomised controlled trial. Is TKA Using Patient-specific Instruments Comparable to Conventional TKA? A Randomized Controlled Study of One System
abstract: This study develops and vali date s a novel patient-specific navigational template for total knee arthroplasty ( TKA ) . A total of 70 patients who underwent TKA were r and omized and divided into conventional method group and navigational template group . In the navigational template group , the patient-specific navigational templates were design ed and used intraoperatively to assist 35 patients with knee arthroplasty . Information on operation time and blood loss was recorded . After surgery , the positions of the prosthesis were evaluated using CT scan and X-rays . Analysis showed significant differences in errors between the two techniques . In addition , mean operation time and mean blood loss were statistically and significantly lower in the navigational template group than in the conventional group . Overall , the navigational template method showed a high degree of accuracy and efficacy Purpose To compare the femoral and tibial components rotational alignment in total knee arthroplasty ( TKA ) performed either with conventional or with patient-specific instrumentation . Methods Forty-five patients underwent primary TKA and were prospect ively r and omized into two groups : 22 patients into the conventional instrumentation group ( group A ) and 23 patients into the Signature ™ patient-specific instrumentation group ( group B ) . All patients underwent computed tomography of the operated knee in the first week after surgery to measure  the components rotation . Results The femoral component rotation was 0.0 ° ( −0.25 , 1.0 ) in group A , and 0.0 ° ( 0.0 , 1.0 ) in group B. The tibial component rotation was −16.0 ° ( −18.5 , 11.8 ) in group A , and −16.0 ° ( −19.0 , −14.0 ) in group B. There were no significant differences between the two groups in tibial and femoral components rotation . The difference between the tibial component rotation and the neutral tibial rotation was similar in both groups [ 2.0 ° ( −0.5 , 6.3 ) in group A and 2.0 ° ( −1.0 , 4.0 ) in group B ] , but the dispersion around the median was different between the two groups . The amplitude of the difference between tibial rotation and neutral position was 27 ° ( −13 , 14 ) in group A and 9 ° ( −3 , 6 ) in group B. Conclusions There is a smaller chance of internal malrotation of the tibial component with the Signature ™ patient-specific instrumentation system , with less dispersion and amplitude of the tibial component rotation around the neutral position . Level of evidence II Abstract Purpose It was our hypothesis that patient-specific instrumentation ( PSI ) can improve the accuracy of the rotational alignment in TKA based on the concept of the system and on the potential to clearly identify pre-operatively during planning the classical anatomical l and marks that serve as references to set-up the rotation both for the femur and tibia . Material s and methods In this prospect i ve comparative r and omized study , 40 patients ( 20 in each group ) operated in our institution between September 2012 and January 2013 by the 2 senior authors were included . R and omization of patients into one of the two groups was done by the Hospital Informatics Department with the use of a systematic sampling method . All patients received the same cemented high-flex mobile bearing TKA . In the PSI group , implant position was compared to the planed position using previously vali date d dedicated software . The position of the implants ( frontal and sagittal ) was compared in the 2 groups on st and ard X-rays , and the rotational position was analysed on post-operative CT-scan . Results 90 % of the patients add < 2 ° or mm of difference between the planned position of the implants and the obtained position , except for the tibial rotation where the variations were much higher . Mean HKA was 179 ° ( 171–185 ) in the PSI group with 4 outliers ( 2 varus : 171 ° and 172 ° :184 ° and 185 ° ) and 178.3 ° with 2 outliers ( 171 ° and 176 ° ) in the control group . No difference was observed between the two groups concerning the frontal and sagittal position of the implants on the ML and AP X-rays . No significant difference of femoral rotation was observed between the two groups with a mean of 0.4 ° in the PSI group and 0.2 ° in the control group ( p : n.s ) . Mean tibial rotation was 8 ° of internal rotation in the PSI group and 15 ° of internal rotation in the st and ard group ( p : n.s ) . Conclusion Based on our results , we were unable to confirm our hypothesis as PSI can not improve rotation in TKA . More work needs to be done to more clearly define the place of PSI in TKA , to keep on improving the accuracy of the system and to better define the individual targets in TKA in terms of frontal , sagittal and rotational positioning of the implant for each patient . Level of evidence Prospect i ve comparative r and omized study , Level II Background and purpose — Although the use of patient-specific positioning guides ( PSPGs ) in total knee replacement ( TKR ) in theory is promising , the technique has not yet proven its superior- ity compared with the conventional method . We compared radio- logical alignment and clinical outcome between TKR performed with the use of PSPGs and the conventional operation method . Patients and methods — 3 hospitals participated in a prospec- tive trial . 109 patients were r and omized to either the conventional method or to the use of PSPGs .  Postoperatively a full-length st and ing anteroposterior radiograph and a postoperative CT scan were taken . On the CT scan the alignments were measured for both the femoral and tibial components in the frontal , sagit- tal , and axial plane . The Knee injury and Osteoarthritis Outcome Score ( KOOS ) , the Eurocol-5D-3L ( Eq5D ) descriptive system and visual analogue scale ( VAS ) , a pain score ( NRS ) , and range of motion ( ROM ) were recorded preoperatively , and at 3 months , 1 , and 2 years . The operation time and length of hospital stay were recorded . Results — 90 patients were available for postoperative CT mea- surements . A statistically significant difference was found between the conventional TKR instrumentation and the use of PSPGs for the frontal femoral ( mean ( SD ) 0.6 ° ( 1.7 ) vs. –0.3 ° ( 2.2 ) , CI 0.08 to 1.69 ) and tibial ( –0.3 ° ( 1.5 ) vs. 0.9 ° ( 2.1 ) , CI –1.98 to –0.44 ) compo- nent angles and for the tibial alignment in the sagittal plane ( –3.8 ° ( 3.0 ) vs. –2.2 ° ( 2.5 ) , CI –2.72 ; –0.42 ) . The proportions of outliers were similar between the groups as well as the hip – knee – ankle angle , the KOOS sub scores , the Eq5D , pain ( NRS ) , ROM , opera- tion time , and length of hospital stay . Interpretation — The use of PSPGs requires a preoperative CT scan or MRI and the guides have an additional cost . As this study was not able to prove any extra benefit of the use of PSPGs we recommend the conventional operation method for TKR Background Recently , patient-specific guides ( PSGs ) have been introduced , cl aim ing a significant improvement in accuracy and reproducibility of component positioning in TKA . Despite intensive marketing by the manufacturers , this cl aim has not yet been confirmed in a controlled prospect i ve trial . Questions / purpose sWe ( 1 ) compared three-planar component alignment and overall coronal mechanical alignment between PSG and conventional instrumentation and ( 2 ) logged the need for applying changes in the suggested position of the PSG . Methods In this r and omized controlled trial , we enrolled 128 patients . In the PSG cohort , surgical navigation was used as an intraoperative control . When the suggested cut deviated more than 3 ° from target , the use of PSG was ab and oned and marked as an outlier . When cranial-caudal position or size was adapted , the PSG was marked as modified . All patients underwent long-leg st and ing radiography and CT scan .  Deviation of more than 3 ° from the target in any plane was defined as an outlier . Results The PSG and conventional cohorts showed similar numbers of outliers in overall coronal alignment ( 25 % versus 28 % ; p = 0.69 ) , femoral coronal alignment ( 7 % versus 14 % ) ( p = 0.24 ) , and femoral axial alignment ( 23 % versus 17 % ; p = 0.50 ) . There were more outliers in tibial coronal ( 15 % versus 3 % ; p = 0.03 ) and sagittal 21 % versus 3 % ; p = 0.002 ) alignment in the PSG group than in the conventional group . PSGs were ab and oned in 14 patients ( 22 % ) and modified in 18 ( 28 % ) . Conclusions PSGs do not improve accuracy in TKA and , in our experience , were somewhat impractical in that the procedure needed to be either modified or ab and oned with some frequency . Level of Evidence Level I , therapeutic study . See instructions for authors for a complete description of levels of evidence BACKGROUND Patient-specific femoral and tibial cutting blocks produced with use of data from preoperative computed tomography ( CT ) or magnetic resonance imaging ( MRI ) scans have been employed recently to optimize component alignment in total knee arthroplasty . We report the results of a r and omized controlled trial in which CT scans were used to compare postoperative component alignment between patients treated with custom instruments  and those managed with traditional instruments . METHODS The in-hospital data and early clinical outcomes , including Knee Society scores , were determined in a r and omized clinical trial of forty-seven patients who had undergone a total of forty-eight primary total knee arthroplasties with patient-specific instruments ( twenty-two knees ) or st and ard instruments ( twenty-six knees ) . Orientation of the implants was compared by using three-dimensional CT data . RESULTS No significant differences were found between the study and control groups with respect to any clinical outcome after a minimum of six months of follow-up . The patient-specific tibial cutting block was ab and oned in favor of a st and ard external alignment jig in seven of the twenty-two study knees because of possible malalignment . A detailed analysis of intent-to-treat and per- protocol groups of study and control knees did not show any significant improvement in component alignment , including femoral component rotation in the axial plane , in the patients treated with the custom instruments . The percentage of outliers -- defined as less than -3 ° or more than 3 ° from the correct orientation of the tibial slope -- was significantly higher in the group treated with use of patient-specific blocks than it was in the control group , in both the intent-to-treat ( 32 % versus 8 % , p = 0.032 ) and the per- protocol ( 47 % versus 6 % , p = 0.0008 ) analysis . CONCLUSIONS There were no significant improvements in clinical outcomes or knee component alignment in patients treated with patient-specific cutting blocks as compared with those treated with st and ard instruments . The group treated with patient-specific cutting blocks had a significantly higher prevalence of malalignment in terms of tibial component slope than the knees treated with st and ard instruments Total knee arthroplasty ( TKA ) is a frequently performed procedure in orthopaedic surgery . Recently , patient-specific instrumentation was introduced to facilitate correct positioning of implants . The aim of this study was to compare the early clinical results of TKA performed with patient-specific CT-based instrumentation and conventional technique . A prospect i ve , r and omized controlled trial on 112 patients was performed between January 2011 and December 2011 . A group of 112 patients who met the inclusion and exclusion criteria were enrolled in this study and r and omly assigned to an experimental or control group . The experimental group comprised 52 patients who received the Signature CT-based implant positioning system , and the control group consisted of 60 patients with conventional instrumentation .  Clinical outcomes were evaluated with the KSS scale , WOMAC scale , and VAS scales to assess knee pain severity and patient satisfaction with the surgery . Specified in-hospital data were recorded . Patients were followed up for 12 months . At one year after surgery , there were no statistically significant differences between groups with respect to clinical outcomes and in-hospital data , including operative time , blood loss , hospital length of stay , intraoperative observations , and postoperative complications . Further high- quality investigations of various patient-specific systems and longer follow-up may be helpful in assessing their utility for TKA BACKGROUND Achieving accurate alignment in total knee arthroplasty ( TKA ) remains a concern . Patient-specific instrumentation ( PSI ) produced using preoperative 3D models was developed to offer surgeons a simplified , reliable , efficient and customised TKA procedure . METHODS In this prospect i ve study , 60 patients underwent TKA with conventional instrumentation and 71 patients were operated on using PSI .  The primary endpoint was surgical time . Secondary endpoints included operating room ( OR ) time , the number of instrument trays used and postoperative radiographic limb alignment . RESULTS Compared to conventional instrumentation , PSI significantly reduced total surgical time by 8.9 ± 3.3 min ( p=0.038 ) , OR time by 8.6 ± 4.2 min ( p=0.043 ) , and the number of instrument trays by six trays ( p<0.001 ) . Mechanical axis malalignment of the lower limb of > 3 ° was observed in 13 % of PSI patients versus 29 % with conventional instrumentation ( p=0.043 ) . PSI predicted the size of the femoral and tibial components actually used in 85.9 % and 78.9 % of cases , respectively . CONCLUSION PSI  improves alignment , surgical and OR time , reduces the number of instruments trays used compared to conventional instrumentation in patients undergoing TKA and results in fewer outliers in overall mechanical alignment in the coronal plane . LEVEL OF EVIDENCE II Prospect i ve comparative therapeutic study Purpose and hypothesisPatient-specific instrumentation ( PSI ) uses 3D preoperative imaging to produce individualized cutting blocks specific to patients ’ anatomy and according to the preoperative plan with the aim to reduce the number of mechanical leg alignment ( MLA ) outliers , to improve implant positioning and to decrease surgery time . The primary purpose of this study was to investigate the efficacy of a specific PSI in comparison with st and ard instrumentation ( SI ) in reducing the number of MLA outliers . It was hypothesized that the number of MLA outliers would be significantly lower in the PSI group . Methods A multicenter r and omized controlled trial was implemented . There were 59 patients in the PSI group and 66 in the SI group . The absolute number of outliers outside the ± 3 ° target neutral MLA was compared between the groups with a Chi-square test . As secondary outcomes , the Knee Society Score ( KSS ) and the Knee Injury and Osteoarthritis Outcome Score ( KOOS ) were compared between the groups preoperatively and at 90-day follow-up . Results There were 15 ( 26.3 % ) MLA outliers in the PSI group and 8 ( 12.3 % ) in the SI group . The number of outliers was not independent from the group ( X2(1 ) = 3.8 , p = 0.04 ; Relative risk = 1.5 ) . Preoperatively , there were no significant differences between the groups when comparing their KSS and KOOS sub-scores . At 90 days postoperatively , the patients in the SI group showed better KOOS- Quality of Life ( KOSS-QOL ) in comparison with the PSI group ( p < 0.0001 ) . Conclusion The use of PSI did not significantly reduce the number of MLA outliers in comparison with SI . There were no differences when comparing the achieved mean MLA of both groups . Level of evidence Level I , prospect i ve r and omized controlled trial Abstract Purpose This r and omized controlled trial was conducted to compare patient-specific instrumentation ( PSI ) to st and ard instrumentation regarding efficacy to achieve a good coronal alignment and differences in surgical time , blood loss and length of stay . Methods Ninety-five of 100 r and omized patients eligible for total knee arthroplasty were analysed .  PSI with magnetic resonance and long-leg radiograph was performed in 47 patients , while 48 patients received st and ard instrumentation .  Primary outcome measure was coronal alignment , evaluated with long-leg radiograph . Deviation > 3 ° varus/valgus was considered an outlier . Surgical time was compared from skin to skin . Length of stay was a post hoc analysis . Blood loss was evaluated comparing the number of blood units spent , fall in haemoglobin and haematocrit levels . Results St and ard instrumentation had a higher number of outliers in the coronal alignment with a relative risk of 3.015 , compared to PSI . Surgical time was reduced by 18 min ( 24.8 % ) with the  PSI  , as well as length of stay , with a half-day reduction . Number of blood units spent was significantly less in the PSI group . Relative risk of transfusion was 7.09 for patients in the st and ard instrumentation group . Difference in Hg and Htc levels were not significant . No patient had to ab and on PSI . Minor changes to preoperative plan occurred in 14.9 % of the patient : cut review in 4.3 % and insert change in 10.6 % . Conclusions Patient-specific instrumentation ( PSI ) is able to provide important advantages over st and ard instrumentation in total knee arthroplasty : it lowers the risk of outliers and transfusion , is a faster procedure and enables a shorter length of stay with a low rate of intraoperative adjustments . Level of evidence AIMS We wished to compare the clinical outcome , as assessed by question naires and the rate of complications , in total knee arthroplasty ( TKA ) undertaken with patient-matched positioning guides ( PMPGs ) or conventional instruments . PATIENTS AND METHODS A total of 180 patients ( 74 men , 106 women ; mean age 67 years ) were included in a multicentre , adequately powered , double-blind , r and omised controlled trial . The mean follow-up was 44 months ( 24 to 57 ) . RESULTS There were no significant or clinical ly relevant differences between the two groups for all outcome measures ( Knee Society Score , p = 0.807 ; Oxford Knee Score , p = 0.304 ; Western Ontario and McMaster osteoarthritis index , p = 0.753 ; visual analogue scale for pain , p = 0.227 ; EuroQol-5D-3L index score , p = 0.610 ; EuroQol-5D-3L VAS health , p = 0.968 . ) There was no difference in the rate of complications ( p = 0.291 ) . CONCLUSION PMPGs are already in relatively common use and their short-term clinical results are equal to conventional instrumented TKA . Cite this article : Bone Joint J 2016;98-B:939 - 44 Summary Background Optimal positioning of implants and restoration of neutral mechanical axis are two primary surgical goals in total knee arthroplasty ( TKA ) . Despite modern instruments and improved surgical techniques , malalignment remains an important cause of early failure after TKA . The aim of this prospect i ve r and omized study was to compare the value of a new patient-matched instrument system ( PMI ) ( SignatureTM ; Biomet , Inc , Warsaw , Indiana ) to that of st and ard TKA surgical instrumentation ( STD ) in terms of coronal mechanical alignment , time of operation and blood loss . Patients and methods A total of 38 patients waiting for primary TKA were enrolled and r and omized into two groups ( 19 PMI and 19 STD ) . Magnetic resonance imaging was performed in all patients in the PMI group , and specific instruments for the femur and tibia were design ed preoperatively . All patients were operated on using the st and ard medial parapatellar approach with no use of tourniquet . Mechanical axis , time for the operation , and blood loss were evaluated . Results Patients in both groups had comparable age , body mass index , preoperative mechanical axis , Knee Society Score , and level of hemoglobin . Postoperative results showed that the PMI group fell significantly closer to neutral mechanical axis ( STD : 2.7 ± 1.7 , PMI : 1.7 ± 0.9 ; P = 0.013 ) with no outliers and a reduced time for the operation . There was no difference in the evaluation blood loss . Conclusions The use of PMI can contribute in achieving better mechanical axis with reduction in outliers and decreased operation time . Due to small differences between PMI and st and ard instruments , additional research are needed to confirm these preliminary results , and to discover potential benefits and functional improvements in the long-term outcome Purpose This prospect i ve , double-blind , r and omised controlled trial was design ed to address the following research questions : firstly , is there a significant difference in outliers in alignment in the frontal and sagittal plane between PSG TKA and conventional TKA . Secondly , is there a significant difference in operation time , blood loss and length of hospital stay between the two techniques . We hypothesise that there will be fewer outliers with PSG TKA and that operation time , blood loss and length of hospital stay can be significantly reduced with PSG . Methods A total of 180 patients were r and omised for PSG TKA ( group 1 ) or conventional TKA ( group 2 ) in two centres . Patients were stratified per hospital . Alignment of the mechanical axis of the leg and flexion/extension and varus/valgus of the individual prosthesis components were measured on digital , st and ing , long-leg and st and ard lateral radiographs by two independent outcome assessors in both centres . Percentages of outliers ( > 3 ° ) were determined . We compared blood loss , operation time and length of hospital stay . Results There was no statistically significant difference in mean mechanical axis or outliers in mechanical axis between groups . No statistically significant difference was found for the alignment of the individual components in the frontal plane nor for the percentages of outliers . There was a statistically significant difference in outliers for the femoral component in the sagittal plane , with a higher percentage of outliers in the group 1 ( p = 0.017 ) . No such significant result was found for the tibial component in that plane . All interclass correlation coefficients were good . Blood loss was 100 mL less in group 1 ( p < 0.001 ) . Operation time was 5 min shorter in group 1 ( p < 0.001 ) . Length of hospital stay was identical with a mean of 3.6 days ( p = 0.657 ) . Conclusions The results in terms of obtaining a neutral mechanical axis and a correct position of the prosthesis components did not differ between groups . A small reduction in operation time and blood loss was found with the PSG system . Future research should especially focus on cost-effectiveness analysis and functional outcome of PSG TKA.Level of evidence Purpose The primary aim of the study was to examine stability and alignment after total knee arthroplasty ( TKA ) using patient-specific instrumentation ( PSI ) and conventional instrumentation ( CI ) . The hypothesis was that stability and alignment would be better using PSI than CI , 12 months postoperatively . The secondary aim included the evaluation of clinical outcomes after TKA . Methods In this prospect i ve r and omized controlled trial , 42 patients with knee osteoarthritis received a Genesis II PS prosthesis with either PSI or CI . Patients visited the hospital preoperatively and postoperatively after 6 weeks and 3 and 12 months . To evaluate stability , varus – valgus laxity was determined in extension and flexion using stress radiographs 12 months postoperatively . Three months postoperatively , a long-leg radiograph and CT scan were obtained to measure hip – knee – ankle ( HKA ) alignment and component rotation . Furthermore , frontal and sagittal alignment of the components , the Knee Society Score , VAS Pain , VAS Satisfaction , Knee injury and Osteoarthritis Outcome score , Patella score ( Kujala ) , University of California Los Angeles activity score , anterior – posterior laxity , ( serious ) adverse device-related events , and intraoperative complications were reported . The clinical outcomes were compared using independent t tests or non-parametric alternatives , and repeated measurements ANOVA with a significance level of p < 0.05 . Results No significant differences were found between the two groups regarding stability , HKA angle , and rotational alignment . In four patients , the PSI did not fit correctly on the tibia and /or femur requiring intraoperative modifications . Both groups improved significantly over time on all clinical outcomes , with no significant differences between the groups 12 months postoperatively . The PSI group showed less tibial slope than the patients in the CI group [ PSI 2.6 ° versus CI 4.8 ° ( p = 0.02 ) ] . Finally , the PSI group more frequently received a thinner insert size than the CI group ( p = 0.03 ) . Conclusions Patients operated with PSI did not differ from CI in terms of stability and alignment . However , in the PSI  group ligament releases were more often required intraoperatively . Furthermore , the two methods did not show different clinical results . It seems that the preoperative planning for the PSI facilitates more conservative bone cuts than CI , but whether this is clinical ly relevant should be investigated . Since PSI is more expensive and time consuming than CI , and does not outperform CI with regard to clinical results , we recommend to use CI.Level of evidence The primary purpose of this prospect i ve , r and omized study was to determine if patient-specific instrumentation ( PSI ) for total knee arthroplasty ( TKA ) shortened surgical time . Secondarily the number of instrument trays and alignment were also compared to cases performed with traditional instrumentation ( TI ) .  Fifty-two cases ( 26 per group ) were r and omized and videotaped to measure the length of surgery , as well as each individual surgical step . Component alignment and mechanical axis was measured radiographically for each patient . Total surgical time was over 4 minutes shorter for patients in the TI group ( 57.4 minutes vs. 61.8 minutes ; P<0.01 ) . More instrument trays were used in the TI group ( 7.3 vs. 2.5 ; P<0.001 ) . There was no significant difference in mechanical alignment between groups on postoperative long alignment radiographs ( P=0.77 ) . In conclusion , PSI did not shorten surgical time or improve alignment compared with TI in this prospect i ve , r and omized trial , but did reduce the required number of trays Abstract Purpose The aim of this prospect i ve 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 ) . Methods 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 clinical ly 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 . Results Data of 222 knees ( CVI : n = 108 , PSI : n = 114 ) were available for analysis after a mean follow-up of 28.6 ± 5.2 months . 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 . Conclusions 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 . Level of evidence Prospect i ve comparative study , Level II Purpose Recently , new custom-fit pin guides in total knee arthroplasty ( TKA ) have been introduced . Use of these guides may reduce operating time . Use of the guides combined with the absence of intramedullary alignment jigs may lead to reduced blood loss and improved early outcomes . Our aim was to evaluate blood loss and early clinical outcomes in patients undergoing minimally invasive TKA using custom-fit magnetic resonance imaging (MRI)–based pin guides . Methods A prospect i ve study in 80 patients was carried out . Patients were divided r and omly into 2 equal groups . In one group , intramedullary alignment jigs were used . In the second group , custom-fit MRI-based pin guides were used . All patients received the same cemented posterior-stabilized implant through a mini-midvastus approach . The volume in the drain bottles was recorded after 48 h. Hb loss was estimated by subtracting the postoperative from the preoperative Hb level . Transfusion requirements and surgical time were recorded . Outcome measures were Knee Society Scores ( KSS ) , knee flexion , knee swelling and pain . Results There was lower mean drainage of blood in the custom-fit group ( 391 ml vs. 603 ml ; p < 0.0001 ) . There was no difference in estimated loss of Hb ( 3.6 g/dl vs. 4.1 g/dl ; n.s . ) and in transfusion requirements ( 7.5 % vs. 10 % ; n.s . ) . Surgical time was reduced in the custom-fit group ( 12 min less ; p = 0.001 ) . KSS measured at week 2 , 6 and 12 showed no significant difference between groups . Knee flexion measured on days 7 , 10 and at week 6 , 12 and knee swelling and pain measured on days 1 , 3 , 10 and at week 6 , 12 showed no significant difference between groups . Conclusions Using custom-fit pin guides reduces blood drainage , but not the estimated Hb loss in minimally invasive TKA and does not affect transfusion rate . Surgical time is reduced . There is no effect on the early clinical outcomes .Level of evidence Therapeutic study , Level AIMS We conducted a r and omised controlled trial to assess the accuracy of positioning and alignment of the components in total knee arthroplasty ( TKA ) , comparing those undertaken using st and ard intramedullary cutting jigs and those with patient-specific instruments ( PSI ) . PATIENTS AND METHODS There were 64 TKAs in the st and ard group and 69 in the PSI group . The post-operative hip-knee-ankle ( HKA ) angle and positioning was investigated using CT scans . Deviation of > 3 ° from the planned position was regarded as an outlier . The operating time , Oxford Knee Scores ( OKS ) and Short Form-12 ( SF-12 ) scores were recorded . RESULTS There were 14 HKA-angle outliers ( 22 % ) in the st and ard group and nine ( 13 % ) in the PSI group ( p = 0.251 ) . The mean HKA-angle was 0.5 ° varus in the st and ard group and 0.2 ° varus in the PSI group ( p = 0.492 ) . The accuracy of alignment in the coronal and axial planes and the proportion of outliers was not different in the two groups . The femoral component was more flexed ( p = 0.035 ) and there were significantly more tibial slope outliers ( 29 % versus 13 % ) in the PSI group ( p = 0.032 ) . Operating time and the median three-month OKS were similar ( p = 0.218 and p = 0.472 , respectively ) . Physical and mental SF-12 scores were not significantly different at three months ( p = 0.418 and p = 0.267 , respectively ) or at one year post-operatively ( p = 0.114 and p = 0.569 ) . The median one-year Oxford knee score was two points higher in the PSI group ( p = 0.049 ) . CONCLUSION Compared with st and ard intramedullary jigs , the use of PSI did not significantly reduce the number of outliers or the mean operating time , nor did it clinical ly improve the accuracy of alignment or the median Oxford Knee Scores . Our data do not support the routine use of PSI when undertaking TKA . Cite this article : Bone Joint J 2016;98-B:1043 - 9 Purpose The aim of this study was to evaluate the accuracy of conventional instrumentation for tibial resection in total knee arthroplasty ( TKA ) as assessed by a computer-based navigation system during each phase of the surgical procedure . The hypothesis is that conventional instrumentation fails to achieve optimal accuracy in final implant positioning , thus leading to surgical errors . Methods Forty primary TKAs were performed .  The resection guide was placed using an extramedullary guide . Accurate guide positioning was assessed by the navigation system prior to the osteotomy . The alignment measurement was repeated after resection and after component implantation in order to quantify the deviation caused by the manual positioning of the prosthetic components . A deviation ≥2 ° was considered unsatisfactory . Results In the frontal plane , unsatisfactory results observed were as follows : 15 % with reference to manual positioning of the resection guide and 10 % with reference to definition of the resection plane with a tendency towards varus malalignment . In the sagittal plane , unsatisfactory results were as follows : 45 % with reference to manual positioning of the resection guide and 40 % with reference to definition of the resection plane with a trend of decreased tibial slope angle . The deviation between bone resection and subsequent implant placement was ≥2 ° in none of the cases . Conclusions The study confirms the hypothesis that conventional instrumentation fails to achieve optimal accuracy in the positioning of the tibial component . During each phase of the surgical procedure , a tendency towards varus malalignment and a decreased tibial slope angle were observed . Levels of evidence II Abstract Purpose The current study investigated the accuracy in achieving proper lower limb alignment and individual component positions after total knee arthroplasty ( TKA ) with 3 different instrumentation techniques . It was hypothesized that patient-specific instruments ( PSI ) would achieve more accurate lower limb alignment and component positions compared to conventional instruments ( CON ) . Methods Ninety knees in 81 patients were r and omized in 1:1:1 ratio into  CON , computer navigation ( NAV )  and PSI  groups to receive TKA . The surgical routines were st and ardized . The lower limb mechanical axis and individual component positions were assessed on st and ard radiographs . Tourniquet time , operation time and patients ’ functional scores were documented . Results Conventional instruments and PSI were more likely to result in an excessively flexed femoral component ( p = 0.001 ) compared to NAV . Number of outliers in postoperative lower limb alignment , and other components positions in the coronal and sagittal plane showed no statistically significant difference . The mean tourniquet time and operation time was significantly shorter in CON and PSI groups than NAV group ( p < 0.001 ) . Four early complications occurred in the PSI group ( p = 0.015 ) . At 3-month follow-up , there was no difference in terms of the knee range of motion and patients ’ function among the 3 groups . Conclusion No significant radiological and clinical benefit could be demonstrated in using PSI over CON or NAV in TKA . Routine use of PSI is not recommended because of the extra cost and waiting time . Level of evidence UNLABELLED Patient-specific cutting guides ( PSCG ) are an extension of preoperative planning for total knee arthroplasty ( TKA ) . We wanted to evaluate their contribution to postoperative lower limb alignment . This study involved primary TKA cases being performed with PSCG between 10/05/2010 and 05/03/2013 and then followed prospect ively . The analysis involved the PSCG usage and postoperative measurement of the patient 's HKA , medial distal femoral joint angle ( MDFA ) and medial proximal tibia joint angle ( MPTA ) .  Of the 104 eligible cases , 68 were included ; 11 of these cases were not performed completely with the PSCG as initially planned . Thus we compared these 11 cases with the 57 where PSCG were used . The preoperative HKA in the included cases was 175.8 ° ± 7.8 ; the postoperative angles on average were 179.2 ° ± 2.9 for the HKA , 89.9 ° ± 1.6 for the MDFA and 89.0 ° ± 2.3 for the MPTA . The average postoperative deviation from the target values was 2.22 ° ± 2.14 for the HKA angle , 1.07 ° ± 1.15 for the MDFA and 1.66 ° ± 1.90 for the MPTA . There were no significant differences between the two groups in any of the measurements . The lower limb alignment goal was achieved in 50 cases ( 73 % ) , with 41 of these achieved with PSCG ( 82 % ) . Of the 18 cases where the target was not achieved , PSCG were used 16 times ( 88 % ) . In this study cohort , lower limb alignment was not significantly closer to an HKA of 180 ° or achieved more often with the use of PSCG versus st and ard instrumentation . Since the results of the two groups can be superimposed , we found no evidence that use of PSCG  improves postoperative lower limb alignment . LEVEL OF EVIDENCE IV . STUDY TYPE Cohort Purpose 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 . Methods A prospect i ve , r and omized 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 r and omly 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 st and ing anteroposterior radiographs of the entire lower limb and st and ard lateral radiographs . Results 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 . Conclusions 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 OBJECTIVE Rotation of femoral components could be optimized to improve function and durability of the knee joint . The purpose of the present study was to assess rotational alignment of femoral component comparing between CT-based , custom cutting blocks and the contemporary total knee arthroplasty , instrument technique . MATERIAL AND METHOD The prospect i ve control study of 80 patients underwent total knee arthroplasty by using PFC Sigma PS total knee design . Rotation offemoral component was analyzed in all patients using postoperative CT scan .  Forty patients were perfonned on by using CT-based , patient-specific cutting blocks with femoral rotational axis relative to transepicondylar axis while forty patients were performed on by using contemporaly instrumentation with alignment at 3 degrees external rotation from posterior condylar line . The rotation of the femoral component with external rotation ofmore than 3 degrees or internal rotation was considered outlier . RESULTS There was no statistically significant difference among ages , gender ; BMI , pre-operative mechanical axis between the two groups . There were eleven outliers in conventional group ( range , 5 degrees ofexternal rotation to 3 degrees of internal rotation ) , three femoral components were in excessive external rotation with the angle of more than 3 degrees and eight femnoral components were in internal rotation . In contrast with custom cutting block group was no outliers offemoral rotation . The average rotational alignment was 1.040 + /- 0.62 external rotation from epicondylar axis in custom cutting group and 1.58 + /- 1.750 in contemporary group . CONCLUSION Custom cutting , block technique significantly reduced the outlier of the femoral component rotation and aided in positioning of the femoral component in optimal alignment . The improvement of femoral rotation showed no difference in clinical outcome between the two groups In this study we r and omised 140 patients who were due to undergo primary total knee arthroplasty ( TKA ) to have the procedure performed using either patient-specific cutting guides ( PSCG ) or conventional instrumentation ( CI ) . The primary outcome measure was the mechanical axis , as measured at three months on a st and ing long-leg radiograph by the hip-knee-ankle ( HKA ) angle . This was undertaken by an independent observer who was blinded to the instrumentation . Secondary outcome measures were component positioning , operating time , Knee Society and Oxford knee scores , blood loss and length of hospital stay . A total of 126 patients ( 67 in the CI group and 59 in the PSCG group ) had complete clinical and radiological data . There were 88 females and 52 males with a mean age of 69.3 years ( 47 to 84 ) and a mean BMI of 28.6 kg/m(2 ) ( 20.2 to 40.8 ) .  The mean HKA angle was 178.9 ° ( 172.5 to 183.4 ) in the CI group and 178.2 ° ( 172.4 to 183.4 ) in the PSCG group ( p = 0.34 ) . Outliers were identified in 22 of 67 knees ( 32.8 % ) in the CI group and 19 of 59 knees ( 32.2 % ) in the PSCG group ( p = 0.99 ) . There was no significant difference in the clinical results ( p = 0.95 and 0.59 , respectively ) . Operating time , blood loss and length of hospital stay were not significantly reduced ( p = 0.09 , 0.58 and 0.50 , respectively ) when using PSCG . The use of PSCG in primary TKA did not reduce the proportion of outliers as measured by post-operative coronal alignment Background Patient-specific CT-based instrumentation may reduce implant malpositioning and improve alignment in TKA . However , it is not known whether this innovation is an advance that benefits patients . Questions / purpose sWe evaluated ( 1 ) the precision of  patient-specific TKA by comparing the incidence of outliers in postoperative alignment between TKAs using  patient-specific instruments  and TKAs using conventional instruments , and ( 2 ) the reliability of patient-specific instruments by intraoperatively investigating whether the surgery could be completed with patient-specific instruments alone . Methods In this r and omized controlled trial , we compared  patient-specific TKA instruments from one manufacturer ( n = 50 ) with conventional TKA instruments ( n = 50 ) . Postoperative hip-knee-ankle angles , femoral component rotation , and coronal and sagittal alignments of each component were measured . The validity of the patient-specific instrument was examined using cross-checking procedures with conventional instruments during the surgeries . When the procedure could not be completed accurately with patient-specific instruments , the procedure was converted to TKA using conventional instruments , and the frequency of this occurrence was tallied . Results Outliers in the hip-knee-ankle angle were comparable between groups ( 12 % in the patient-specific instrument group and 10 % in the conventional instrument group ) . Other parameters such as sagittal alignment and femoral component rotation did not differ in terms of outliers . Patient-specific guides were ab and oned in eight knees ( 16 % ) during the surgery because of malrotation of the femoral components and decreased slope of the tibia . Conclusions Accuracy was comparable between TKAs done with patient-specific instruments and those done with conventional instruments . However , the patient-specific instrument procedures had to be aborted frequently , incurring expenses that did not benefit patients .Level of Evidence Level II , therapeutic study . See Instructions for Authors for a complete description of levels of evidence
target: We did not find any differences between PSI and SI with respect to any other parameters .
  Conclusions PSI  has advantages in axial alignment of the femoral component , operative time , and perioperative blood loss relative to SI .
  No significant differences were found between PSI and SI with respect to alignment of the remaining components , number of outliers , or length of hospital stay .
background: Purpose The purpose of the present study was to compare patient-specific instrumentation ( PSI ) with st and ard instrumentation ( SI ) in patients undergoing total knee arthroplasty ( TKA ) .
  PSI is hypothesized to have advantages with respect to component alignment ; number of outliers ( defined as alignment > 3 ° from the target alignment ) ; operative time ; perioperative blood loss ; and length of hospital stay .
  This new surgical technique is expected to exhibit superior performance .