Patient-specific instrumentation in total knee arthroplasty: simpler, faster and more accurate than standard instrumentation—a randomized controlled trial Improved alignment and operating room efficiency with patient-specific instrumentation for TKA. Patient-specific computed tomography based instrumentation in total knee arthroplasty: a prospective randomized controlled study Comparison between patient-specific instruments and conventional instruments and computer navigation in total knee arthroplasty: a randomized controlled trial In-vivo alignment comparing patient specific instrumentation with both conventional and computer assisted surgery (CAS) instrumentation in total knee arthroplasty. The radiological outcomes of patient-specific instrumentation versus conventional total knee arthroplasty Stability and alignment do not improve by using patient-specific instrumentation in total knee arthroplasty: a randomized controlled trial Patient-specific instrumentation improved mechanical alignment, while early clinical outcome was comparable to conventional instrumentation in TKA Kinematic femoral alignment with gap balancing and patient-specific instrumentation in total knee arthroplasty: a randomized clinical trial The value of patient-matched instrumentation in total knee arthroplasty. Patient-specific instrumentation does not shorten surgical time: a prospective, randomized trial. No improvement in reducing outliers in coronal axis alignment with patient-specific instrumentation Component alignment and clinical outcome following total knee arthroplasty: a randomised controlled trial comparing an intramedullary alignment system with patient-specific instrumentation. Rotation in total knee arthroplasty: no difference between patient-specific and conventional instrumentation Patient-specific instrumentation for total knee arthroplasty does not match the pre-operative plan as assessed by intra-operative computer-assisted navigation Patient-matched instruments versus standard instrumentation in total knee arthroplasty: a prospective randomized study Patient-Specific CT-Based Instrumentation versus Conventional Instrumentation in Total Knee Arthroplasty: A Prospective Randomized Controlled Study on Clinical Outcomes and In-Hospital Data
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 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 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 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 Patient specific instrumentation ( PSI ) was developed to increase total knee arthroplasty ( TKA ) accuracy and efficiency . The study purpose was to compare immediate post-operative mechanical alignment , achieved using PSI , with conventional and computer assisted surgery ( CAS ) instruments in high volume TKA practice s. This prospect i ve , multicenter , non-r and omized study accrued 66 TKA patients using PSI .  A computed tomography ( CT ) based algorithm was used to develop the surgical plan . Sixty-two percent were females , 99 % were diagnosed with osteoarthritis , average age at surgery was 66 years , and 33 was the average body mass index . A historical control group was utilized that underwent TKA using conventional instruments ( n=86 ) or CAS ( n=81 ) , by the same set of surgeons . Postoperative mechanical alignment was comparable across the groups . Operative time mean and variance were significant Abstract Purpose The aim of this study was to investigate the post-operative radiological outcomes of patient-specific instrumentation ( PSI ) surgery versus conventional total knee arthroplasty ( TKA ) . Methods Sixty patients scheduled for a primary TKA were prospect ively divided into PSI or conventional technique . Coronal and sagittal radiographic long limb films were taken post-operatively . The accepted values for normal alignment were 180 ° ± 3 ° for hip-knee-ankle angle ; 90 ° ± 3 ° for coronal femoral component angle or coronal tibia component angle ; 0 ° to 3 ° flexion for sagittal femoral component angle and 0 ° to 7 ° posterior slope for sagittal tibia component angle . Results For hip-knee-ankle angle , there were 21 % more outliers in the PSI group compared to the conventional group ( p = 0.045 ) . Most of these outliers had valgus deformity in the PSI group and varus deformity in the conventional group ( p = 0.045 ) . For implant placement , there was no difference in the proportion of outliers between the two groups . There was also no difference in the duration of surgery . Conclusions This study showed that PSI surgery is associated with a larger proportion of outliers for lower limb alignment . PSI surgery as an alternative to conventional TKA is not advisable . Level of evidence II 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 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 While patient-specific instrumentation ( PSI ) in total knee arthroplasty ( TKA ) allows for transfer of the preoperative plan onto bony l and marks , the soft tissue balancing is not affected . The goals of this r and omized clinical trial were to compare PSI and the measured resection technique ( conventional ) with PSI and the gap balancing technique .  Fifty patients were r and omized to TKA with conventional PSI ( PSI-S ) ( n = 25 ) or to PSI with additional gap balancing ( PSI-GB ) ( n = 25 ) . All patients were clinical ly examined at 3 and 12 months postoperatively . Data on the range of motion , the Knee Society Score , the Western Ontario and McMasters Universities Osteoarthritis Index , the High-Flexion Knee Score ( HFKS ) , and the Forgotten Joint Score ( FJS ) were compiled at follow-up . Statistically significant improvements were found for all clinical parameters in the PSI-GB group compared to the PSI-S group at 3 months postoperatively and for FS , FJS , and HFKS at 12 months . However , the relevance of these differences , as well as their effect on long-term outcomes , needs to be evaluated further . In conclusion , patient-specific instrumentation combined with gap balancing yielded good early clinical outcomes The purpose of the current prospect i ve , r and omized study was to compare the value of a new mechanically aligned patient-matched instrument system for total knee arthroplasty ( TKA ) ( Visionaire ; Smith & Nephew , Inc , Memphis , Tenn ) ( VIS ) to that of st and ard TKA surgical instrumentation ( STD ) . Twenty-nine primary TKA patients were enrolled and completed surgery ( 15 VIS and 14 STD ) . Postoperatively , mechanical alignment was significantly closer to neutral zero in the VIS group ( 1.7 ° vs 2.8 ° ; P = .03 ) . Furthermore , the VIS group demonstrated significant reductions in duration of hospital stay , operative time , incision length , and number of used instrument trays ( P < .05 ) . Although additional research is underway to confirm these preliminary results , this evidence suggests that patient-matched instrumentation may support repeatable improvements in surgical accuracy and hospital efficiency 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 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 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 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 Abstract Purpose The introduction of patient-specific instruments ( PSI ) for guiding bone cuts could increase the incidence of malalignment in primary total knee arthroplasty . The purpose of this study was to assess the agreement between one type of patient-specific instrumentation ( Zimmer PSI ) and the pre-operative plan with respect to bone cuts and component alignment during TKR using imageless computer navigation . Methods A consecutive series of 30 femoral and tibial guides  were assessed in-theatre by the same surgeon using computer navigation . Following surgical exposure , the PSI cutting guides were placed on the joint surface and alignment assessed using the navigation tracker . The difference between in-theatre data and the pre-operative plan was recorded and analysed . Results The error between in-theatre measurements and pre-operative plan for the femoral and tibial components exceeded 3 ° for 3 and 17 % of the sample , respectively , while the error for total coronal alignment exceeded 3 ° for 27 % of the sample . Conclusion The present results indicate that alignment with Zimmer PSI cutting blocks , assessed by imageless navigation , does not match the pre-operative plan in a proportion of cases . To prevent unnecessary increases in the incidence of malalignment in primary TKR , it is recommended that these devices should not be used without objective verification of alignment , either in real-time or with post-operative imaging . Further work is required to identify the source of discrepancies and vali date these devices prior to routine use . Level of evidence II 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 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
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 .
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 .