Patient-specific computed tomography based instrumentation in total knee arthroplasty: a prospective randomized controlled study Patient-specific Total Knee Arthroplasty Required Frequent Surgeon-directed Changes The value of patient-matched instrumentation in total knee arthroplasty. Patient-specific Guides Do Not Improve Accuracy in Total Knee Arthroplasty: A Prospective Randomized Controlled Trial Patient-Specific CT-Based Instrumentation versus Conventional Instrumentation in Total Knee Arthroplasty: A Prospective Randomized Controlled Study on Clinical Outcomes and In-Hospital Data Contribution of patient-specific cutting guides to lower limb alignment for total knee arthroplasty. Accuracy of manual instrumentation of tibial cutting guide in total knee arthroplasty Is TKA Using Patient-specific Instruments Comparable to Conventional TKA? A Randomized Controlled Study of One System Comparison between patient-specific instruments and conventional instruments and computer navigation in total knee arthroplasty: a randomized controlled trial Patient specific cutting blocks are currently of no proven value. Functional comparison of posterior cruciate-retaining versus posterior stabilized total knee arthroplasty. Patient-matched instruments versus standard instrumentation in total knee arthroplasty: a prospective randomized study Accuracy of CT-based patient-specific guides for total knee arthroplasty in patients with post-traumatic osteoarthritis 4D-SPECT/CT in orthopaedics: a new method of combined quantitative volumetric 3D analysis of SPECT/CT tracer uptake and component position measurements in patients after total knee arthroplasty Comparison of Early Postoperative Rehabilitation Outcome following Total Knee Arthroplasty Using Different Surgical Approaches and Instrumentation Comparison of radiographic alignment of imageless computer-assisted surgery vs conventional instrumentation in primary total knee arthroplasty. In-vivo alignment comparing patient specific instrumentation with both conventional and computer assisted surgery (CAS) instrumentation in total knee arthroplasty.
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 Background Patient-specific instrumentation potentially improves surgical precision and decreases operative time in total knee arthroplasty ( TKA ) but there is little supporting data to confirm this presumption . Questions / purpose sWe asked whether patient-specific instrumentation would require infrequent intraoperative changes to replicate a single surgeon ’s preferences during TKA and whether patient-specific instrumentation guides would fit securely . Methods We prospect ively evaluated the plan and surgery in 60 patients treated with 66 TKAs performed with patient-specific instrumentation and recorded any changes . A subset of six postoperative radiographic changes to the femoral and tibial components ( implant size , coronal and sagittal alignment ) was analyzed to determine if surgeon intervention was beneficial . Each guide was evaluated to determine fit . We compared patient demographics and implant sizing in the patient-specific instrumentation group with a control group in which traditional instrumentation was used . Results We recorded 161 intraoperative changes in 66 knee arthroplasties ( 2.4 changes/knee ) performed with patient-specific instrumentation . The predetermined implant size was changed intraoperatively in 77 % of femurs and 53 % of tibias . We identified a subset of 95 intraoperative changes that could be radiographically evaluated to determine if our changes were an improvement or detriment to reaching goal alignment . Eighty-two of the 95 changes ( 86 % ) made by the surgeon were an improvement to the recommended alignment or size of patient-specific instrumentation . The guide did not fit securely on eight femurs ( 12 % ) and three tibias ( 5 % ) . Tourniquet time and blood loss were not improved with patient-specific instrumentation . Conclusions We caution surgeons against blind acceptance of patient-specific instrumentation technology without supportive data .Level of Evidence Level III , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence 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 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 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 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 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 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 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 cutting guides generated by preoperative Magnetic Resonance Imaging ( MRI ) of the patient 's extremity have been proposed as a method of improving the consistency of Total Knee Arthroplasty ( TKA ) alignment and adding efficiency to the operative procedure . The cost of this option was evaluated by quantifying the savings from decreased operative time and instrument processing costs compared to the additional cost of the MRI and the guide .  Coronal plane alignment was measured in an unselected consecutive series of 200 TKAs , 100 with st and ard instrumentation and 100 with custom cutting guides .  While the cutting guides had significantly lower total operative time and instrument processing time , the estimated $ 322 savings was overwhelmed by the $ 1,500 additional cost of the MRI and the cutting guide . All measures of coronal plane alignment were equivalent between the two groups . The data does not currently support the proposition that patient specific guides add value to TKA A prospect i ve , r and omized comparison of posterior cruciate-retaining ( PCR ) and posterior stabilized ( PS ) total knee arthroplasties ( TKAs ) was conducted in 20 patients who underwent bilateral TKAs for osteoarthritis . All procedures were performed by a single surgeon . One knee was implanted with a PCR TKA , and a contralateral knee with a PS TKA . Both prosthetic design s were of the same TKA series , with comparable surface geometries . Patients had a clinical and radiographic evaluation at a mean of 31.7 months for PCR TKAs and 30.6 months for PS TKAs postoperatively . There were no significant differences between the PCR and PS TKAs in postoperative knee scores . However , postoperative improvement in range of motion was significantly superior in the PS group 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 Abstract Published clinical trials who studied the accuracy of patient-specific guides ( PSG ) for total knee arthroplasty exclude patients with articular deformity of the knee joint . We prospect ively analysed a series of 30 patients with post-traumatic osteoarthritis of the knee joint with use of PSG . At 1 year post-operative , the achieved biomechanical ( HKA ) axis and varus/valgus of the femur and tibia components were measured on anterior – posterior ( AP ) long-st and ing weight-bearing radiographs . Flexion/extension of the femoral and AP slope of the tibia component was measured on st and ard lateral radiographs . Percentages > 3 ° deviation of the pre-operative planned HKA axis and individual implant components were considered as outliers . Approved and used implant size , median blood loss ( ml ) and operation time ( min ) were obtained from the operation records . Pre- and 1-year post-operative patient-reported outcome measures ( PROMs ) were performed . Eighty-three per cent of the patients had a HKA axis restored <3 ° of the pre-operative planned alignment . Varus/valgus outliers were 0.0 and 6.7 % for the femoral and tibial components , respectively . Percentages of outliers of flexion/extension were 36.7 % for the femoral component and 10.0 % for the AP slope of the tibial component . Median blood loss was 300 ml ( 50–700 ) , while operation time was 67 min ( 44–144 ) . In 20 % of all cases , the approved implant size was changed into one size smaller . One-year post-operative PROMs improved significantly . We conclude that the accuracy of CT-based PSG is not impaired in patients with post-traumatic osteoarthritis and this modality can restore biomechanical limb alignment Objective The purpose was to evaluate the intra- and inter-observer reliability of combined quantitative 3D-volumetric single-photon emission computed tomography (SPECT)/CT analysis including size , intensity and localisation of tracer uptake regions and total knee arthroplasty ( TKA ) position . Material s and methods Tc-99m-HDP-SPECT/CT of 100 knees after TKA were prospect ively analysed . The anatomical areas represented by a previously vali date d localisation scheme were 3D-volumetrically analysed . The maximum intensity was recorded for each anatomical area . Ratios between the respective value and the mid-shaft of the femur as the reference were calculated . Femoral and tibial TKA position ( varus – valgus , flexion – extension , internal rotation– external rotation ) were determined on 3D-CT . Two consultant radiologists/nuclear medicine physicians interpreted the SPECT/CTs twice with a 2-week interval . The inter- and intra-observer reliability was determined ( ICCs ) . Kappa values were calculated for the area with the highest tracer uptake between the observers . Results The measurements of tracer uptake intensity showed excellent inter- and intra-observer reliabilities for all regions ( tibia , femur and patella ) . Only the tibial shaft area showed ICCs < 0.89 . The kappa values were almost perfect ( 0.856 , p < 0.001 ; 95 % CI 0.778 , 0.922 ) . For measurements of the TKA position , there was strong agreement within and between the readings of the two observers ; the ICCs for the orientation of TKA components for inter- and intra-observer reliability were nearly perfect ( ICCs > 0.84 ) . Conclusion This combined 3D-volumetric st and ardised method of analysing the location , size and the intensity of SPECT/CT tracer uptake regions ( “ hotspots ” ) and the determination of the TKA position was highly reliable and represents a novel promising approach to biomechanics Purpose . To assess early postoperative rehabilitation outcome following  computer-assisted total knee arthroplasty ( TKA )  or st and ard instrumentation TKA using a medial parapatellar or subvastus approach . Methods . A prospect i ve controlled trial of 70 consecutive patients undergoing TKA with a low contact stress rotating platform prosthesis was conducted . Patients were r and omised to receive surgery with either computer navigation or st and ard instrumentation .  A medial parapatellar or subvastus approach was used according to the surgeons ' preference . Outcome measures included preoperative knee function , intra-operative factors , and postoperative rehabilitation . Results . Duration of surgery was significantly longer when using computer navigation ; however , operating time decreased with greater experience . A higher incidence and duration of early postoperative quadriceps dysfunction was associated with computer-assisted TKA through the medial parapatellar approach than through the subvastus approach or TKA performed with st and ard instrumentation . No patient who received surgery through the subvastus approach had a lag of more than 20 degrees , at 48 hours postoperatively , regardless of the instrumentation used . Conclusion . Computer-assisted TKA through a medial parapatellar approach was associated with delayed recovery of the quadriceps during early postoperative rehabilitation . This was due to the additional quadriceps dissection required to place the femoral tracking array . The subvastus approach is therefore recommended for computer-assisted TKA A total of 208 patients were enrolled in a multicenter , prospect i ve r and omized , institutional review board-approved study that compared preoperative surgical plan to postoperative 2-dimensional radiographic alignment measured by a blinded review er for  primary total knee arthroplasty ( TKA ) implanted using computer-assisted surgery ( CAS ) compared with conventional TKA instrumentation . The results demonstrated a statistically significant improvement in the coronal tibial component alignment ( P < .03 ) and failed to demonstrate a statistically significant improvement in the mechanical axis , femoral coronal/sagittal , and tibial sagittal alignment . Knee Society Score knee and function scores and 6-minute walk test were equivalent between the 2 treatment groups at all postoperative intervals . There was a statistically significant increase in the skin-skin time ( P < .0001 ) and the time until first bone cut ( P < .0001 ) for the CAS knees compared with those implanted with conventional instrumentation . The use of CAS in this r and omized clinical trial conducted at high-volume centers did not offer a clinical ly meaningful improvement in postoperative alignment , clinical , functional , or safety outcomes compared with conventional TKA 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
There was a trend towards a protective effect  with PSCB for the risk of femoral component outliers , but the opposite was observed for the tibial component .
Conclusions This meta- analysis found no evidence that using patient-specific cutting blocks provides superior accuracy to using manual instrumentation during TKA
Purpose Because published studies on the accuracy achieved with patient-specific guides during total knee arthroplasty ( TKA ) contradict each other , this systematic review and meta- analysis sought to compare radiological TKA outcomes when patient-specific cutting blocks ( PSCB ) were used to the outcomes when st and ard manual instrumentation was used .