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Theeuwen DMJ, Dorling IM, Most J, van Drumpt RAM, van der Weegen W, Welting TJM, Schotanus MGM, Boonen B. Patient-specific instrumentation improved clinical outcome and implant survival but is not superior compared to conventional total knee arthroplasty: Ten years follow-up of a multicenter double-blind randomized controlled trial. Knee Surg Sports Traumatol Arthrosc 2025; 33:1371-1377. [PMID: 39403802 DOI: 10.1002/ksa.12505] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/04/2024] [Revised: 10/02/2024] [Accepted: 10/02/2024] [Indexed: 03/28/2025]
Abstract
PURPOSE Patient-specific instrumentation (PSI) is a commonly used technique designed to improve mechanical alignment in total knee arthroplasty (TKA) and was therefore believed to lead to better clinical outcome and implant survival rates compared with conventional instruments (CIs). To date, long-term results comparing these two techniques are not available. METHODS This study is a 10-year follow-up of a previous double-blind multicenter randomized controlled trial where PSI was compared with CI. Patients with osteoarthritis of the knee who were candidates for TKA were included. Exclusion criteria were metal near the knee-, ankle- or hip joint, patients with contra-indications for a magnetic resonance imaging (MRI) scan and patients who had previous knee surgery (except arthroscopic meniscectomy). Clinical outcomes were assessed using patient-reported outcome measures (PROMs), and the analysis was performed with a general linear mixed model for repeated measurements. Kaplan-Meier curves were used to compare revision rates. X-rays were obtained and examined by two individual reviewers for any signs of loosening of the components. RESULTS At a mean follow-up of 10.1 (SD 0.1) years, 129 patients (loss to follow-up 23%) were analysed in this trial. No statistically significant difference between the two groups were found for any of the PROMs and revision rates were comparable, six in the PSI group and three in the CI group (p = 0.29). Two X-rays in the PSI group showed a radiolucent line of the femoral component. CONCLUSION At 10-year follow-up, PSI does not lead to better clinical outcome or survival of the prosthesis compared with CI. LEVEL OF EVIDENCE Level 1.
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Affiliation(s)
- Dieuwertje M J Theeuwen
- Department of Orthopaedic Surgery and Traumatology, Zuyderland Medical Center, Sittard-Geleen, The Netherlands
- School of Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands
| | - Isobel M Dorling
- Department of Orthopaedic Surgery and Traumatology, Zuyderland Medical Center, Sittard-Geleen, The Netherlands
- School of Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands
| | - Jasper Most
- Department of Orthopaedic Surgery and Traumatology, Zuyderland Medical Center, Sittard-Geleen, The Netherlands
- School of Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands
| | | | | | - Tim J M Welting
- School of Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands
| | - Martijn G M Schotanus
- Department of Orthopaedic Surgery and Traumatology, Zuyderland Medical Center, Sittard-Geleen, The Netherlands
- School of Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands
| | - Bert Boonen
- Department of Orthopaedic Surgery and Traumatology, Zuyderland Medical Center, Sittard-Geleen, The Netherlands
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Uchio Y, Ishijima M, Ikeuchi M, Ikegawa S, Ishibashi Y, Omori G, Shiba N, Takeuchi R, Tanaka S, Tsumura H, Deie M, Tohyama H, Yoshimura N, Nakashima Y. Japanese Orthopaedic Association (JOA) clinical practice guidelines on the management of Osteoarthritis of the knee - Secondary publication. J Orthop Sci 2025; 30:185-257. [PMID: 39127581 DOI: 10.1016/j.jos.2024.06.013] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/26/2024] [Accepted: 06/28/2024] [Indexed: 08/12/2024]
Affiliation(s)
- Yuji Uchio
- Department of Orthopaedic Surgery, Shimane University, Izumo, Japan.
| | | | - Masahiko Ikeuchi
- Department of Orthopaedic Surgery, Kochi University, Nankoku, Japan
| | - Shiro Ikegawa
- Laboratory for Bone and Joint Diseases, Center for Integrated Medical Science (IMS), RIKEN, Tokyo, Japan
| | - Yasuyuki Ishibashi
- Department of Orthopedic Surgery, Hirosaki University Graduate School of Medicine, Hirosaki, Japan
| | - Go Omori
- Department of Health and Sports, Niigata University of Health and Welfare, Niigata, Japan
| | - Naoto Shiba
- Department of Orthopaedics, Kurume University School of Medicine, Fukuoka, Japan
| | - Ryohei Takeuchi
- Department of Joint Surgery Center, Yokohama Sekishinkai Hospital, Yokohama, Japan
| | - Sakae Tanaka
- Department of Orthopaedic Surgery, University of Tokyo, Tokyo, Japan
| | - Hiroshi Tsumura
- Department of Orthopaedic Surgery, Oita University, Oita, Japan
| | - Masataka Deie
- Department of Orthopaedic Surgery, Aichi Medical University, Nagakute, Japan
| | | | - Noriko Yoshimura
- Department of Preventive Medicine for Locomotive Organ Disorders, 22nd Century Medical and Research Center, University of Tokyo, Tokyo, Japan
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Spece H, Kurtz MA, Piuzzi NS, Kurtz SM. Patient-reported outcome measures offer little additional value two years after arthroplasty : a systematic review and meta-analysis. Bone Joint J 2025; 107-B:296-307. [PMID: 40025985 DOI: 10.1302/0301-620x.107b3.bjj-2024-0910.r1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 03/04/2025]
Abstract
Aims The use of patient-reported outcome measures (PROMs) to assess the outcome after total knee (TKA) and total hip arthroplasty (THA) is increasing, with associated regulatory mandates. However, the robustness and clinical relevance of long-term data are often questionable. It is important to determine whether using long-term PROMs data justify the resources, costs, and difficulties associated with their collection. The aim of this study was to assess studies involving TKA and THA to determine which PROMs are most commonly reported, how complete PROMs data are at ≥ five years postoperatively, and the extent to which the scores change between early and long-term follow-up. Methods We conducted a systematic review of the literature. Randomized controlled trials (RCTs) with sufficient reporting of PROMs were included. The mean difference in scores from the preoperative condition to early follow-up times (between one and two years), and from early to final follow-up, were calculated. The mean rates of change in the scores were calculated from representative studies. Meta-analyses were also performed on the most frequently reported PROMs. Results A total of 24 studies were assessed. The most frequently reported PROMs were the Oxford Knee Score (OKS) for TKA and the University of California, Los Angeles activity scale for THA. The mean rate of follow-up based on the number of patients available at final follow-up was 70.5% (39.2% to 91.0%) for knees and 82.1% (63.2% to 92.3%) for hips. The actual rates of collection of PROM scores were lower. For TKA, the mean OKS, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and transformed WOMAC changes were -16.3 (95% CI -17.5 to -15.2), 23.2 (95% CI 17.2 to 29.2), and -29.7 (95% CI -32.4 to -27.0) points for short-term follow-up. These decreased to 1.3 (95% CI -0.8 to 3.3), -3.4 (95% CI -7.0 to 0.3), and 4.7 (95% CI -1.5 to 10.9) points for the remaining follow-up. A similar meta-analysis was not possible for studies involving THA. We commonly observed that the scores plateaued after between one and two years, and that there was little or no change beyond this time. Conclusion The long-term PROMs for TKA and THA beyond one or two years are often incomplete and lose sensitivity at this time. Given the considerable resources, costs, and challenges associated with the collection of these scores, their clinical value is questionable. Therefore, consideration should be given to abandoning the requirement for the collection of long-term PROMs in favour of more robust and reliable measures of success that offer more clinical relevance and use.
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Affiliation(s)
- Hannah Spece
- Drexel University School of Biomedical Engineering, Science, and Health Systems, Philadelphia, Pennsylvania, USA
| | - Michael A Kurtz
- Drexel University School of Biomedical Engineering, Science, and Health Systems, Philadelphia, Pennsylvania, USA
| | - Nicolas S Piuzzi
- Department of Orthopedic Surgery, Cleveland Clinic Foundation, Cleveland, Ohio, USA
| | - Steven M Kurtz
- Drexel University School of Biomedical Engineering, Science, and Health Systems, Philadelphia, Pennsylvania, USA
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Theeuwen D, Bemelmans Y, Boonen B, Haveman I, van der Weegen W, Schotanus M. The influence of the number of postoperative radiological outliers on the survival and clinical outcome of total knee arthroplasty. J Clin Orthop Trauma 2025; 60:102834. [PMID: 39759465 PMCID: PMC11697279 DOI: 10.1016/j.jcot.2024.102834] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/21/2022] [Revised: 04/10/2024] [Accepted: 11/20/2024] [Indexed: 01/07/2025] Open
Abstract
Introduction After total knee arthroplasty (TKA), dissatisfaction rates are described up to 30 %. Optimal alignment of the prosthesis in TKA is believed to improve clinical outcome and survival rates. Radiological outliers after TKA are used to define this alignment. Limited evidence is available on the cumulative effect of these outliers on survival or clinical outcome. The purpose of this study is to assess whether the amount of postoperative femoral and/or tibial radiological outliers, measured in different planes, influences the survival and clinical outcome after TKA. Methods Prospective data were used from a previously published randomized trial, with a mean follow-up of 5-years after surgery. Data of 168 patients who received TKA were assessed. Patients were divided into four groups: 0, 1, 2 or ≥3 postoperative radiological outliers of the femoral and/or tibial component in different planes (e.g. frontal, sagittal). Revision rates were analysed and clinical outcome was assessed using PROMs. The study used a general linear model for repeated measures to compare the difference of each questionnaire over time between the groups. Results No statistically significant differences were found between patients with 0, 1, 2 or ≥3 outliers regarding improvement of postoperative PROMs. Data was underpowered to detect a possible relationship between the number of outliers and the survival of the prosthesis. Conclusion The number of postoperative radiological outliers did not influence clinical outcome after TKA. High-powered studies are needed to examine the influence of these outliers on survival rates.
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Affiliation(s)
- D.M.J. Theeuwen
- Department of Orthopaedic Surgery, Zuyderland Medical Center, Dr H vd Hoffplein 1, 6162 AG, Sittard-Geleen, the Netherlands
| | - Y.F.L. Bemelmans
- Department of Orthopaedic Surgery, Zuyderland Medical Center, Dr H vd Hoffplein 1, 6162 AG, Sittard-Geleen, the Netherlands
| | - B. Boonen
- Department of Orthopaedic Surgery, Zuyderland Medical Center, Dr H vd Hoffplein 1, 6162 AG, Sittard-Geleen, the Netherlands
| | - I. Haveman
- Department of Orthopaedic Surgery, Zuyderland Medical Center, Dr H vd Hoffplein 1, 6162 AG, Sittard-Geleen, the Netherlands
| | - W. van der Weegen
- Department of Orthopaedic Surgery, St. Anna Hospital, bogardeind 2, 5664 EH, Geldrop, the Netherlands
| | - M.G.M. Schotanus
- Department of Orthopaedic Surgery, Zuyderland Medical Center, Dr H vd Hoffplein 1, 6162 AG, Sittard-Geleen, the Netherlands
- Faculty of Health, Medicine & Life Sciences, Care and Public Health Research Institute, Maastricht University Medical Centre, universiteitssingel 40, 6229 ER, Maastricht, the Netherlands
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Schippers P, Wunderlich F, Afghanyar Y, Buschmann V, Klonschinski T, Drees P, Eckhard L. High patient satisfaction with Customized Total Knee Arthroplasty at five year follow-up. INTERNATIONAL ORTHOPAEDICS 2024; 48:3101-3108. [PMID: 39320497 PMCID: PMC11564282 DOI: 10.1007/s00264-024-06325-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/15/2024] [Accepted: 09/12/2024] [Indexed: 09/26/2024]
Abstract
PURPOSE Despite numerous studies demonstrating promising short-term outcomes of Total Knee Arthroplasty (TKA) with Customized Individually Made (CIM) implants, there is a significant lack of data on their mid-term effectiveness. Given the increasing number of TKAs performed annually, the rising demand for CIM implants, and the associated burden of revision surgeries, understanding the mid-term performance of CIM implants is crucial. Therefore, this study aims to report on the mid-term (minimum 5 years) outcomes of TKA using a CIM implant. METHODS This retrospective cohort study included a consecutive series of 116 patients who received the ConforMIS® iTotal CR implant between 2015 and 2018. Inclusion criteria were end-stage knee osteoarthritis with coronal deformities below 10° and absence of ligamentous instability. Exclusion criteria included simultaneous bilateral TKA. Patients were followed up at a minimum of five years post-surgery. They completed a questionnaire reporting on satisfaction, pain levels using the Visual Analogue Scale (VAS), current weight, the Oxford Knee Score (OKS), and the Forgotten Joint Score for the knee (FJS-knee). Statistical analysis included descriptive statistics for demographic and clinical variables, and outcomes were reported as means with ranges. RESULTS The mean follow-up duration was 5.9 ± 0.8 years (range 5-7.4 years). 90% of patients stated they would undergo the same operation again, and 93% were either satisfied or very satisfied. The mean VAS for pain at rest was 2 ± 1.5 (range 0-6) and during exercise was 3 ± 2 (range 0-8). 58 patients (53%) managed to lose weight. The mean OKS was 41 ± 9 points (range 15-48), and the mean FJS-knee was 67 ± 23 points (range 4-100). No severe complications occurred. CONCLUSION CIM TKA using the ConforMIS® iTotal CR implant can achieve excellent results with 93% of patients being satisfied or very satisfied at mid-term follow-up of five years. Prospective, randomized, and patient-blinded trials comparing off-the-shelf (OTS) TKAs with CIM implants are necessary to evaluate whether these implants are superior or not.
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Affiliation(s)
- Philipp Schippers
- Department of Orthopedics and Traumatology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.
| | - Felix Wunderlich
- Department of Orthopedics and Traumatology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany
| | - Yama Afghanyar
- Department of Orthopedics and Traumatology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany
| | - Victoria Buschmann
- Department of Orthopedics and Traumatology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany
| | - Thomas Klonschinski
- Department of Orthopedics and Traumatology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany
| | - Philipp Drees
- Department of Orthopedics and Traumatology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany
| | - Lukas Eckhard
- Department of Orthopedics and Traumatology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany
- Praxis für Gelenkchirurgie Bad Kreuznach, 55543, Bad Kreuznach, Germany
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McAuliffe M, Darwish I, Anderson J, Nicholls A, Corfield S, Harries D, Vertullo C. Association of Technology Usage and Decreased Revision TKA Rates for Low-Volume Surgeons Using an Optimal Prosthesis Combination: An Analysis of 53,264 Primary TKAs. J Bone Joint Surg Am 2024; 106:2063-2072. [PMID: 39325857 DOI: 10.2106/jbjs.24.00539] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 09/28/2024]
Abstract
BACKGROUND Technology (navigation and robotics) usage during total knee arthroplasty (TKA) is often supported by literature involving high-volume surgeons and hospitals, but the value of technology for lower-volume surgeons is uncertain. This study aimed to determine if there was a relationship among surgeon volume, technology usage, and revision rate when using an optimal prosthesis combination (OPC). METHODS Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) data were obtained from January 1, 2008, to December 31, 2022, for all primary TKA procedures performed for osteoarthritis using an OPC by a known surgeon ≥5 years after their first recorded procedure. The interaction between surgeon volume and conventional-instrumentation (CV) versus technology-assisted (TA) TKA was assessed. The cumulative percent revision (CPR) was determined by Kaplan-Meier estimates. Cox proportional-hazards methods were used to compare rates of revision by surgeon volume and by the interaction of volume and technology. Subanalyses were undertaken to examine major and minor revisions separately, and to assess the influence of technology on revision rates relative to those of a surgeon undertaking 100 TKA/year. RESULTS Of the 53,264 procedures that met the inclusion criteria, 31,536 were TA-TKA and 21,728 were CV-TKA. Use of technology reduced the all-cause revision rate for surgeons with a volume of <50 TKA/year and the rate of minor revisions for surgeons with a volume of <40 TKA/year. No interaction between surgeon volume and the rate of major revision surgery was found. With CV-TKA by a surgeon with a 100-TKA/year volume as the comparator, all-cause and major revision rates were significantly elevated for surgeons undertaking <50 and <100 TKA/year, respectively. In contrast, analysis of TA-TKA showed no difference in rates of all-cause or major revisions for surgeons undertaking <100 TKA/year compared with 100 TKA/year. CONCLUSIONS TA-TKA was associated with a decrease in the revision rate for lower-volume surgeons but no significant alterations in revision rate for higher-volume surgeons. Preferential use of TA-TKA by lower-volume surgeons should be considered. LEVEL OF EVIDENCE Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.
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Affiliation(s)
- Michael McAuliffe
- Australian Orthopaedic Association National Joint Replacement Registry, Adelaide, South Australia, Australia
- Queensland University of Technology, Brisbane, Queensland, Australia
- CJM Centre, Ipswich, Queensland, Australia
| | - Ibrahim Darwish
- Sydney Orthopaedic Research Institute, Sydney, New South Wales, Australia
| | - Jon Anderson
- Brisbane Orthopaedic and Sports Medicine Centre (BOSMC), Brisbane, Queensland, Australia
- School of Human Movement and Nutrition Sciences, University of Queensland, St Lucia, Queensland, Australia
| | - Alex Nicholls
- Sydney Orthopaedic Research Institute, Sydney, New South Wales, Australia
| | - Sophie Corfield
- Australian Orthopaedic Association National Joint Replacement Registry, Adelaide, South Australia, Australia
| | - Dylan Harries
- Australian Orthopaedic Association National Joint Replacement Registry, Adelaide, South Australia, Australia
| | - Christopher Vertullo
- Australian Orthopaedic Association National Joint Replacement Registry, Adelaide, South Australia, Australia
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Theeuwen D, Schoenmakers D, Scholtes M, Kalaai S, Schotanus M, Boonen B. First long-term analysis of survival and clinical outcome in patient-specific instrumentation for total knee arthroplasty: follow-up of a prospective cohort study. Acta Orthop Belg 2024; 90:51-56. [PMID: 38669649 DOI: 10.52628/90.1.11822] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 04/28/2024]
Abstract
Patient-specific instrumentation (PSI) was introduced to improve post-operative alignment, and consequently the revision rate and clinical results after total knee arthroplasty (TKA). Short- to mid-term data are conflicting regarding these theoretical advantages of PSI. The purpose of this retrospective analysis was to evaluate the survival rate and clinical outcome in PSI TKA 8.4 years after initial surgery. To our knowledge, no other study investigated long-term follow-up of TKA procedures using PSI. From a total cohort of 184 consecutive patients (200 TKA) 136 patients (144 TKA, 72%) were prospectively analysed at a mean follow-up of 8.4 years (±0.4). A survival analysis with all-cause revision of TKA as endpoint was performed. Patient-reported outcome measures (PROMs) were obtained preoperatively and after 1-, 2-, 5-, and 8.4-years of follow-up. Differences between these moments of follow-up were analysed. At final follow-up, 4 TKAs (2%) had undergone revision, all between 2-4 years after primary surgery. Reasons for revision were late infection, aseptic loosening, instability and polyethylene insert breakage. The median score of certain PROMs (WOMAC, VAS, EQ-index, EQ-VAS) decreased compared to previous follow-up scores but were significantly higher than preoperative scores. After 8.4 years of follow-up, no additional revision surgery was performed compared to 5-years postoperatively. Certain PROMs at 8.4-year follow-up decreased compared to earlier moments of follow-up, but all PROMs improved compared to preoperative PROMs.
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Dorling IM, Geenen L, Heymans MJLF, Most J, Boonen B, Schotanus MGM. Cost-effectiveness of patient specific vs conventional instrumentation for total knee arthroplasty: A systematic review and meta-analysis. World J Orthop 2023; 14:458-470. [PMID: 37377995 PMCID: PMC10292058 DOI: 10.5312/wjo.v14.i6.458] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/21/2022] [Revised: 04/26/2023] [Accepted: 05/15/2023] [Indexed: 06/19/2023] Open
Abstract
BACKGROUND Over the past years, patient specific instrumentation (PSI) for total knee arthroplasty (TKA) has been implemented and routinely used. No clear answer has been given on its associated cost and cost-effectiveness when compared to conventional instrumentation (CI) for TKA.
AIM To compare the cost and cost-effectiveness of PSI TKA compared to CI TKA.
METHODS A literature search was performed in healthcare, economical healthcare, and medical databases (MEDLINE, EMBASE, CINAHL, Web of Science, Cochrane Library, EconLit). It was conducted in April 2021 and again in January 2022. Relevant literature included randomised controlled trials, retrospective studies, prospective studies, observational studies, and case control studies. All studies were assessed on methodological quality. Relevant outcomes included incremental cost-effectiveness ratio, quality-adjusted life years, total costs, imaging costs, production costs, sterilization associated costs, surgery duration costs and readmission rate costs. All eligible studies were assessed for risk of bias. Meta-analysis was performed for outcomes with sufficient data.
RESULTS Thirty-two studies were included into the systematic review. Two were included in the meta-analysis. 3994 PSI TKAs and 13267 CI TKAs were included in the sample size. The methodological quality of the included studies, based on Consensus on Health Economic Criteria-scores and risk of bias, ranged from average to good. PSI TKA costs less than CI TKA when considering mean operating room time and its associated costs and tray sterilization per patient case. PSI TKA costs more compared to CI TKA when considering imaging and production costs. Considering total costs per patient case, PSI TKA is more expensive in comparison to CI TKA. Meta-analysis comparing total costs for PSI TKA, and CI TKA showed a significant higher cost for PSI TKA.
CONCLUSION Cost for PSI and CI TKA can differ when considering distinct aspects of their implementation. Total costs per patient case are increased for PSI TKA when compared to CI TKA.
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Affiliation(s)
- Isobel M Dorling
- Department of Orthopaedic Surgery and Traumatology, Zuyderland Medical Center, Sittard-Geleen 6162 BG, Limburg, Netherlands
| | - Lars Geenen
- Department of Orthopaedic Surgery and Traumatology, Zuyderland Medical Center, Sittard-Geleen 6162 BG, Limburg, Netherlands
| | - Marion J L F Heymans
- Department of Orthopaedic Surgery and Traumatology, Zuyderland Medical Center, Sittard-Geleen 6162 BG, Limburg, Netherlands
- Zuyderland Academy, Zuyderland Medical Center, Sittard-Geleen 6155 NH, Limburg, Netherlands
| | - Jasper Most
- Department of Orthopaedic Surgery and Traumatology, Zuyderland Medical Center, Sittard-Geleen 6162 BG, Limburg, Netherlands
- School of Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht 6229 ER, Limburg, Netherlands
| | - Bert Boonen
- Department of Orthopaedic Surgery and Traumatology, Zuyderland Medical Center, Sittard-Geleen 6162 BG, Limburg, Netherlands
| | - Martijn G M Schotanus
- Department of Orthopaedic Surgery and Traumatology, Zuyderland Medical Center, Sittard-Geleen 6162 BG, Limburg, Netherlands
- School of Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht 6229 ER, Limburg, Netherlands
- Department of Orthopaedic Surgery and Traumatology, Maastricht University Medical Center, Maastricht 6229 HX, Limburg, Netherlands
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9
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Schönthaler W, Dauwe J, Holzer LA. Patient-specific instrumentation in total knee arthroplasty: a review of the current literature. Acta Orthop Belg 2023; 89:299-306. [PMID: 37924556 DOI: 10.52628/89.2.11543] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/06/2023]
Abstract
Total knee arthroplasty (TKA) is one of the most frequently performed interventions in the field of Orthopaedic surgery. Over the last decades the implantation technique has improved continuously. The majority of patients is satisfied with the clinical outcome of TKA. However in various clinical follow-ups, up to 20% of unsatisfied patients can be observed. Periprosthetic infection and aseptic loosening seem to be the most common reasons for failure. Malalignment has been discussed as a cause of aseptic loosening and often leads to revision surgery. In order to increase the precision of implant positioning and alignment, new technologies such as patient-specific instrumentation (PSI) have been developed. Since the introduction of PSI, multiple clinical studies have been performed analyzing the clinical and radiological outcome of TKA with PSI technique. This review covers the recent literature of PSI in respect to surgical accuracy, clinical outcome, time- and cost-effectiveness.
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Hinloopen JH, Puijk R, Nolte PA, Schoones JW, de Ridder R, Pijls BG. The efficacy and safety of patient-specific instrumentation in primary total knee replacement: a systematic review and meta-analysis. Expert Rev Med Devices 2023; 20:245-252. [PMID: 36736371 DOI: 10.1080/17434440.2023.2177152] [Citation(s) in RCA: 6] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/05/2023]
Abstract
INTRODUCTION Patient-specific instrumentation (PSI) for primary total knee arthroplasty (TKA) surgery has been shown to increase accuracy of component positioning. However, it is unclear whether this also translates to actual benefits for patients in terms of better outcomes (efficacy) or less complications such as revisions (safety). We therefore systematically reviewed the literature to determine the efficacy and safety of PSI in primary TKA. METHODS Randomized controlled trials comparing PSI to non-PSI in primary TKA were included. A random effects model was used with meta-regression in case of heterogeneity. RESULTS Forty-three studies were included with a total of 1816 TKA in the PSI group and 1887 TKA in the control group. There were no clinically relevant differences between the PSI-group and non-PSI group regarding all outcomes. There was considerable heterogeneity: meta-regression analyses showed that the year the study was published was an important effect modifier. Early publications tended to show a positive effect for PSI compared to non-PSI TKA, whereas later studies found the opposite. CONCLUSION Based on evidence of moderate certainty, our study suggested that there were no clinically relevant differences in efficacy and safety between patients treated with PSI TKA and patients treated with non-PSI TKA.
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Affiliation(s)
- J H Hinloopen
- Department of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands
| | - R Puijk
- Department of Orthopedic Surgery, Spaarne Gasthuis, Hoofddorp, the Netherlands
| | - P A Nolte
- Department of Orthopedic Surgery, Spaarne Gasthuis, Hoofddorp, the Netherlands.,Department Oral Cell Biology, Academic Centre for Dentistry (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
| | - J W Schoones
- Directorate of Research Policy (Formerly: Walaeus Library), Leiden University Medical Centre, Leiden, The Netherlands
| | - R de Ridder
- Department of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands.,Department of Orthopaedics, Reinier Haga Orthopaedic Centre, Zoetermeer, Netherlands
| | - B G Pijls
- Department of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands
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11
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Rudran B, Magill H, Ponugoti N, Williams A, Ball S. Functional outcomes in patient specific instrumentation vs. conventional instrumentation for total knee arthroplasty; a systematic review and meta-analysis of prospective studies. BMC Musculoskelet Disord 2022; 23:702. [PMID: 35870913 PMCID: PMC9308296 DOI: 10.1186/s12891-022-05620-2] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/01/2021] [Accepted: 07/05/2022] [Indexed: 11/18/2022] Open
Abstract
Background Total Knee Arthroplasty (TKA) is an established surgical option for knee osteoarthritis (OA). There are varying perceptions of the most suitable surgical technique for making bone cuts in TKA. Conventional Instrumentation (CI) uses generic cutting guides (extra- and intra-medullary) for TKA; however, patient specific instrumentation (PSI) has become a popular alternative amongst surgeons. Methods A literature search of electronic databases Embase, Medline and registry platform portals was conducted on the 16th May 2021. The search was performed using a predesigned search strategy. Eligible studies were critically appraised for methodological quality. The primary outcome measure was Knee Society Function Score. Functional scores were also collected for the secondary outcome measures: Oxford Knee Score (OKS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), Knee Injury and Osteoarthritis Outcome Score (KOOS) and Visual Analog Scale (VAS) for pain. Review Manager 5.3 was used for all data synthesis and analysis. Results There is no conclusive evidence in the literature to suggest that PSI or CI instrumentation is better for functional outcomes. 23 studies were identified for inclusion in this study. Twenty-two studies (18 randomised controlled trials and 4 prospective studies) were included in the meta analysis, with a total of 2277 total knee arthroplasties. There were 1154 PSI TKA and 1123 CI TKA. The majority of outcomes at 3-months, 6-months and 12 show no statistical difference. There was statistical significance at 24 months in favour of PSI group for KSS function (mean difference 4.36, 95% confidence interval 1.83–6.89). The mean difference did not exceed the MCID of 6.4. KSS knee scores demonstrated statistical significance at 24 months (mean difference 2.37, 95% confidence interval (CI) 0.42—4.31), with a MCID of 5.9. WOMAC scores were found to be statistically significant favouring PSI group at 12 months (mean difference -3.47, 95% confidence interval (CI) -6.57- -0.36) and 24 months (mean difference -0.65, 95% confidence interval (CI) -1.28—-0.03), with high level of bias noted in the studies and a MCID of 10. Conclusions This meta-analysis of level 1 and level 2 evidence shows there is no clinical difference when comparing PSI and CI KSS function scores for TKA at definitive post operative time points (3 months, 6 months, 12 months and 24 months). Within the secondary outcomes for this study, there was no clinical difference between PSI and CI for TKA. Although there was no clinical difference between PSI and CI for TKA, there was statistical significance noted at 24 months in favour of PSI compared to CI for TKA when considering KSS function, KSS knee scores and WOMAC scores. Studies included in this meta-analysis were of limited cohort size and prospective studies were prone to methodological bias. The current literature is limited and insufficiently robust to make explicit conclusions and therefore further high-powered robust RCTs are required at specific time points.
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Minimum 5-Year Outcomes of a Multicenter, Prospective, Randomized Control Trial Assessing Clinical and Radiological Outcomes of Patient-Specific Instrumentation in Total Knee Arthroplasty. J Arthroplasty 2022; 37:1579-1585. [PMID: 35077818 DOI: 10.1016/j.arth.2022.01.039] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/12/2021] [Revised: 01/16/2022] [Accepted: 01/17/2022] [Indexed: 02/02/2023] Open
Abstract
BACKGROUND Patient-specific instrumentation (PSI) was developed to produce more accurate alignment of components and consequently improve clinical outcomes when used in total knee arthroplasty. We compare radiological accuracy and clinical outcomes at a minimum of 5-year follow-up between patients randomized to undergo total knee arthroplasty performed using PSI or traditional cutting block techniques. METHODS This multicenter, randomized control trial included patients blinded to the technique 1used. Outcome measures were coronal alignment measured radiologically, Euroqol-5D, Oxford knee score, and International Knee Society Score measured at 1- and 5-year follow-up. RESULTS At a minimum 5-year follow-up, there were 38 knees in the PSI group and 39 in the conventional instrumentation group for analysis. Baseline demographics and clinical outcome scores were matched between groups. Overall, there was no significant difference in the coronal femoral angle (P = .59), coronal tibial angle (P = .37), tibiofemoral angle (P = .99), sagittal femoral angle (P = .34), or the posterior tibia slope (P = .12) between knees implanted using PSI and those implanted with traditional cutting blocks. On the measurement of coronal alignment, intraobserver reliability tests demonstrated substantial agreement (k = 0.64). Clinical outcomes at both 1-year and 5-year follow-up demonstrated statistically significant and clinically relevant improvement in scores from baseline in both groups, but no difference could be detected between the Euroqol-5D (P = .78), Oxford knee score (P = .24), or International Knee Society Score (P = .86) between the 2 groups. CONCLUSION This study has shown no additional benefit to PSI in terms of improved alignment or functional outcomes at minimum 5-year follow-up over traditional techniques.
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Gauci MO. Patient-specific guides in orthopedic surgery. Orthop Traumatol Surg Res 2022; 108:103154. [PMID: 34838754 DOI: 10.1016/j.otsr.2021.103154] [Citation(s) in RCA: 16] [Impact Index Per Article: 5.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/12/2020] [Revised: 03/10/2021] [Accepted: 04/29/2021] [Indexed: 02/03/2023]
Abstract
The interest of patient-specific guides (PSGs) lies in reliable intraoperative achievement of preoperative planning goals. They are a form of instrumentation optimizing intraoperative precision and thus improving the safety and reproducibility of surgical procedures. Clinical superiority, however, has not been demonstrated. The various steps from design to implementation leave room for error, which needs to be known and controlled by the surgeon who is responsible for final outcome. Instituting large-scale patient-specific surgery requires management systems for guides and innovative implants which cannot be a simple extension of current practices. We shall approach the present state of knowledge regarding PSGs via 5 questions: (1) What is a PSG? Single-use instrumentation produced after preoperative planning, aiming exclusively to optimize procedural exactness. (2) How to use and assess PSGs in orthopedic surgery? Strict rules of use must be adhered to. Any deviation from the predefined objective is, necessarily, an error that must be identified as such. (3) Do PSGs provide greater surgical exactness? The contribution of PSGs varies greatly between procedures. Exactness is enhanced in the spine, in osteotomies around the knee and in bone-tumor surgery. In the shoulder, their contribution is seen only in complex cases. Data are sparse for hip replacement, and controversial for knee replacement. (4) What are the expected benefits of PSGs? As well as improving exactness, PSGs allow a lower radiation dose and shorter operating time. They also enable junior surgeons to train in techniques otherwise reserved to hyperspecialists. (5) How to include PSGs in everyday practice? As well as their potential clinical interest, PSGs involve deep changes in organization, equipment provision and economic model. LEVEL OF EVIDENCE: V; expert opinion.
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Affiliation(s)
- Marc-Olivier Gauci
- Institut Universitaire Locomoteur et du Sport (IULS), CHU de Nice, Unité de Recherche Clinique Côte d'Azur (UCA), Hôpital Pasteur II, 30, voie Romaine, 06000 Nice, France.
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吴 碧, 王 跃, 郝 鹏, 冯 均. [Clinical application of distal femoral patient-specific cutting guide based on knee CT and full-length X-ray film of lower extremities]. ZHONGGUO XIU FU CHONG JIAN WAI KE ZA ZHI = ZHONGGUO XIUFU CHONGJIAN WAIKE ZAZHI = CHINESE JOURNAL OF REPARATIVE AND RECONSTRUCTIVE SURGERY 2021; 35:188-194. [PMID: 33624472 PMCID: PMC8171691 DOI: 10.7507/1002-1892.202008113] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Subscribe] [Scholar Register] [Received: 08/27/2020] [Revised: 12/16/2020] [Indexed: 11/03/2022]
Abstract
OBJECTIVE To discuss the feasibility and accuracy of distal femoral patient-specific cutting guide in total knee arthroplasty (TKA) based on knee CT and full-length X-ray film of lower extremities. METHODS Between July 2016 and February 2017, 20 patients with severe knee joint osteoarthritis planned to undergo primary TKA were selected as the research object. There were 9 males and 11 females; aged 53-84 years, with an average of 69.4 years. The body mass index was 22.1-31.0 kg/m 2, with an average of 24.8 kg/m 2. The preoperative range of motion (ROM) of the knee joint was (103.0±19.4)°, the pain visual analogue scale (VAS) score was 5.4±1.3, and the American Hospital of Special Surgery (HSS) score was 58.1±11.3. Before operation, a three-dimensional model of the knee joint was constructed based on the full-length X-ray film of lower extremities and CT of the knee joint. The distal femoral patient-specific cutting guide was designed and fabricated, and the thickness of the distal femoral osteotomy was determined by digital simulation. The thickness of the internal and external condyle of the distal femur osteotomy before operation and the actual thickness of the intraoperative osteotomy were compared. The intraoperative blood loss, postoperative drainage loss, and hidden blood loss were recorded. The ROM of knee joint, VAS score, and HSS score at 3 months after operation were recorded to evaluate effectiveness. The position of the coronal and sagittal plane of the distal femoral prosthesis were assessed by comparing the femoral mechanical-anatomical angle (FMAA), anatomical lateral distal femoral angle (aLDFA), mechanical femoral tibial angle (mFTA), distal femoral flexion angle (DFFA), femoral prosthesis flexion angle (FPFA), anatomical lateral femoral component angle (aLFC), and the angle of the femoral component and femoral shaft (α angle) between pre- and post-operation. RESULTS TKA was successfully completed with the aid of the distal femoral patient-specific cutting guide. There was no significant difference between the thickness of the internal and lateral condyle of the distal femur osteotomy before operation and the actual thickness of the intraoperative osteotomy ( P>0.05). All patients were followed up 3 months. All incisions healed by first intention, and there was no complications such as periarticular infection and deep vein thrombosis. Except for 1 patient who was not treated with tranexamic acid, the intraoperative blood loss of the rest 19 patients ranged from 30 to 150 mL, with an average of 73.2 mL; the postoperative drainage loss ranged from 20 to 500 mL, with an average of 154.5 mL; and the hidden blood loss ranged from 169.2 to 1 400.0 mL, with an average of 643.8 mL. At 3 months after operation, the ROM of the knee was (111.5±11.5)°, and there was no significant difference when compared with the preoperative one ( t=-1.962, P=0.065). The VAS score was 2.4±0.9 and HSS score was 88.2±7.5, showing significant differences when compared with the preoperative ones ( t=7.248, P=0.000; t=-11.442, P=0.000). Compared with the preoperative measurements, there was a significant difference in mFTA ( P<0.05), and there was no significant difference in aLDFA, FMAA, or DFFA; compared with the preoperative plan, there was no significant difference in FPFA, aLFC, or α angle ( P>0.05). CONCLUSION The use of distal femoral patient-specific cutting guide based on knee CT and full-length X-ray film of lower extremity can achieve precise osteotomy, improve coronal and sagittal limb alignment, reduce intraoperative blood loss, and obtain satisfactory short-term effectiveness.
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Affiliation(s)
- 碧 吴
- 德阳市人民医院骨科（四川德阳 618000）Department of Orthopaedics, People’s Hospital of Deyang City, Deyang Sichuan, 618000, P.R.China
- 四川省医学科学院•四川省人民医院骨科（成都 610072）Department of Orthopedics, Sichuan Academy of Medical Science & Sichuan Provincial People’s Hospital, Chengdu Sichuan, 610072, P.R.China
| | - 跃 王
- 德阳市人民医院骨科（四川德阳 618000）Department of Orthopaedics, People’s Hospital of Deyang City, Deyang Sichuan, 618000, P.R.China
| | - 鹏 郝
- 德阳市人民医院骨科（四川德阳 618000）Department of Orthopaedics, People’s Hospital of Deyang City, Deyang Sichuan, 618000, P.R.China
| | - 均伟 冯
- 德阳市人民医院骨科（四川德阳 618000）Department of Orthopaedics, People’s Hospital of Deyang City, Deyang Sichuan, 618000, P.R.China
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Meier M, Calliess T, Tibesku C, Beckmann J. [New technologies (robotics, custom-made) in unicondylar knee arthroplasty-pro]. DER ORTHOPADE 2021; 50:130-135. [PMID: 33346868 DOI: 10.1007/s00132-020-04058-5] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/24/2022]
Abstract
BACKGROUND Unicondylar knee arthroplasty offers the advantage that partial degenerative changes can be addressed with partial prosthetic solutions, thus preserving as much of the native joint as possible, including the cruciate ligaments. On the other hand, the number of revisions is still higher than for total knee endoprosthetics. In the literature, the causes mentioned are insufficient fit of the components as well as surgical errors. The use of new technologies to achieve a better fit and higher surgical precision and reproducibility, therefore, represents a promising approach. INDIVIDUAL ENDOPROSTHETICS Individual endoprosthetics offers the advantage that the prosthesis is adapted to the individual anatomy of each patient and not the patient's anatomy to the prosthesis, as is the case with standard prostheses. This allows for an optimal fit of the prosthesis while avoiding excessive bone resections and soft tissue releases. ROBOTICS The use of robotics in endoprosthetics makes it easier to correctly perform bone resections and align components. This ensures high and reproducible precision even for surgeons with lower case numbers. Studies on individual unicondylar endoprosthetics and robotics are reporting promising results. However, long-term results of high-quality randomized studies must be awaited in order to make a scientifically sound statement.
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Affiliation(s)
- Malin Meier
- Universitätsklinik für Orthopädische Chirurgie und Traumatologie, Inselspital, Bern, Schweiz
| | | | | | - Johannes Beckmann
- Sportklinik Stuttgart, Taubenheimstr. 8, 70372, Stuttgart, Deutschland.
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Thijs E, Theeuwen D, Boonen B, van Haaren E, Hendrickx R, Vos R, Borghans R, Kort N, Schotanus MGM. Comparable clinical outcome and implant longevity after CT- or MRI-based patient-specific instruments for total knee arthroplasty: a 2-year follow-up of a RCT. Knee Surg Sports Traumatol Arthrosc 2020; 28:1821-1826. [PMID: 31270591 DOI: 10.1007/s00167-019-05616-x] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/24/2019] [Accepted: 07/01/2019] [Indexed: 11/30/2022]
Abstract
PURPOSE Patient-specific instruments (PSI) are already widespread used in total knee arthroplasty (TKA). Either computed tomography (CT) scans or magnetic resonance imaging (MRI) scans are used pre-operatively to create jigs to guide resection during surgery. This study is a sequel of previous work that showed significantly more radiological outliers for posterior slope when CT-based guides were used. The aim of this study was to assess differences in revision rate and clinical outcome between the two groups at 2-year follow-up. METHODS At the 2-year follow-up, 124 patients were analysed in this prospective, randomised single-blind study. A survival analysis with revision of the TKA as endpoint was performed. Patients fulfilled four patient-reported outcome measurements (PROMs). Scores on the questionnaires were compared between both groups at the different follow-up visits. RESULTS At final follow-up, there was no significant difference in the survival rates of the CT- and MRI-based PSI surgery. Postoperatively, the PROMs significantly improved within each group compared with the pre-operative values. There were no significant differences for the PROMs between both groups at the 2-years follow-up. CONCLUSIONS Although previous results showed more outliers regarding posterior slope for CT-based PSIs, no difference in revision rate or the outcome of PROMs was found at 2-year follow-up. Further research to determine what the influence is of radiological outliers on implant survival and clinical outcomes is necessary. LEVEL OF EVIDENCE I.
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Affiliation(s)
- Elke Thijs
- Department of Orthopaedic Surgery, Zuyderland Medical Centre, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands
| | - Dieuwertje Theeuwen
- Department of Orthopaedic Surgery, Zuyderland Medical Centre, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands
| | - Bert Boonen
- Department of Orthopaedic Surgery, Zuyderland Medical Centre, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands
| | - Emil van Haaren
- Department of Orthopaedic Surgery, Zuyderland Medical Centre, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands
| | - Roel Hendrickx
- Department of Orthopaedic Surgery, Zuyderland Medical Centre, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands
| | - Rein Vos
- Department of Methodology and Statistics, Maastricht University Medical Center, Maastricht, The Netherlands
| | - Rob Borghans
- Department of Radiology, Zuyderland Medical Center, Sittard-Geleen, The Netherlands
| | | | - Martijn G M Schotanus
- Department of Orthopaedic Surgery, Zuyderland Medical Centre, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands.
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Patient-Specific or Conventional Instrumentations: A Meta-analysis of Randomized Controlled Trials. BIOMED RESEARCH INTERNATIONAL 2020; 2020:2164371. [PMID: 32258107 PMCID: PMC7085852 DOI: 10.1155/2020/2164371] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 08/11/2019] [Accepted: 02/13/2020] [Indexed: 02/05/2023]
Abstract
Objective To conduct a meta-analysis of randomized controlled trials (RCTs) to compare knee arthroplasty with patient-specific instrumentation (PSI) with the conventional instrumentation (CI). Methods RCTs were selected in PubMed and Embase from 2012 to 2018. Key data extracted included malalignment of mechanical axis, blood loss, surgical time, Oxford Knee Score (OKS), Knee Society Score (KSS), length of stay, and complications. Subgroup analysis was also performed regarding different PSI systems and different image processing methods. Results 29 RCTs with 2487 knees were eligible for the meta-analysis. Results showed that PSI did not improve the alignment of the mechanical axis compared with CI, but MRI-based PSI and Visionaire-specific PSI decrease the risk of malalignment significantly (P = 0.04 and P = 0.04 and P = 0.04 and P = 0.04 and P = 0.04 and Conclusion PSI reduced the blood loss and improved KSS. MRI-based PSI reduced operative time and risk of malalignment of mechanical axis compared with CT-based PSI. Moreover, Visionaire-specific PSI achieves better alignment result of the mechanical axis than other systems.
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