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      No advantage with navigated versus conventional mechanically aligned total knee arthroplasty—10 year results of a randomised controlled trial

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          Abstract

          Purpose

          Computer-assisted surgery (CAS) total knee arthroplasty (TKA) remains a controversial area of surgical practice. The aim of this study is to report the ten-year revision rates and patient-reported outcome measures (PROMS) of a single-blinded, prospective, randomised controlled trial comparing electromagnetically (EM) navigated and conventional TKA.

          Methods

          199 patients were randomised to receive either EM navigated or conventional TKA where the aim of implantation was neutral mechanical alignment in all cases. Ten-year revision rates were collated and compared between the two intervention groups. Longitudinal PROMS data was collected prospectively at various time points up to 10 years post-operatively.

          Results

          Over the ten-year period, there were 23 deaths (22.8%) in the EM navigation cohort and 30 deaths (30.6%) in the conventional cohort. At 10 years post-operatively, there was no statistically significant difference in all cause revision between the EM navigation and conventional cohort (4.0 vs 6.1%, p = 0.429). When analysing causes of revision that might be influenced by utilising EM navigation, there was no statistically significant difference in revisions (3.0% EM navigated vs 4.1% conventional group, p = 0.591). Patients that received navigated TKAs had improved Oxford Knee Society, American Knee Society Score and range of motion at 3 months following surgery compared to conventional TKA ( p = 0.002, p = 0.032, and p = 0.05, respectively). However, from 1 to 10 years post-operatively, both interventions had equivalent outcomes.

          Conclusion

          There is no difference in revision rates or clinical outcomes comparing EM navigated versus conventional TKA at ten-year follow-up. The expected mortality rate makes it unlikely that a difference in revision rates will reach statistical significance in the future. In the setting of an experienced knee arthroplasty surgeon, it is difficult to justify the additional costs of CAS in TKA surgery.

          Level of evidence

          I

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          Most cited references26

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          Coronal alignment after total knee replacement.

          Maquet's line passes from the centre of the femoral head to the centre of the body of the talus. The distance of this line from the centre of the knee on a long-leg radiograph provides the most accurate measure of coronal alignment. Malalignment causes abnormal forces which may lead to loosening after knee replacement. We report a series of 115 Denham knee replacements performed between 1976 and 1981 using the earliest design of components, inserted with intramedullary guide rods. Patients were assessed clinically and long-leg standing radiographs were taken before operation, soon after surgery and up to 12 years later. In two-thirds of the knees (68%) Maquet's line passed through the middle third of the prosthesis on postoperative films and the incidence of subsequent loosening was 3%. When Maquet's line was medial or lateral to this, an error of approximately +/- 3 degrees, the incidence of loosening at a median period of eight years was 24%. This difference is highly significant (p = 0.001). Accurate coronal alignment appears to be an important factor in prevention of loosening. Means of improving the accuracy of alignment and of measuring it on long-leg radiographs are discussed.
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            Alignment options for total knee arthroplasty: A systematic review.

            In spite of improvements in implant designs and surgical precision, functional outcomes of mechanically aligned total knee arthroplasty (MA TKA) have plateaued. This suggests probable technical intrinsic limitations that few alternate more anatomical recently promoted surgical techniques are trying to solve. This review aims at (1) classifying the different options to frontally align TKA implants, (2) at comparing their safety and efficacy with the one from MA TKAs, therefore answering the following questions: does alternative techniques to position TKA improve functional outcomes of TKA (question 1)? Is there any pathoanatomy not suitable for kinematic implantation of a TKA (question 2)? A systematic review of the existing literature utilizing PubMed and Google Scholar search engines was performed in February 2017. Only studies published in peer-reviewed journals over the last ten years in either English or French were reviewed. We identified 569 reports, of which 13 met our eligibility criteria. Four alternative techniques to position a TKA are challenging the traditional MA technique: anatomic (AA), adjusted mechanical (aMA), kinematic (KA), and restricted kinematic (rKA) alignment techniques. Regarding osteoarthritic patients with slight to mid constitutional knee frontal deformity, the KA technique enables a faster recovery and generally generates higher functional TKA outcomes than the MA technique. Kinematic alignment for TKA is a new attractive technique for TKA at early to mid-term, but need longer follow-up in order to assess its true value. It is probable that some forms of pathoanatomy might affect longer-term clinical outcomes of KA TKA and make the rKA technique or additional surgical corrections (realignment osteotomy, retinacular ligament reconstruction etc.) relevant for this sub-group of patients. Longer follow-up is needed to define the best indication of each alternative surgical technique for TKA. Level I for question 1 (systematic review of Level I studies), level 4 for question 2.
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              A randomised controlled trial of kinematically and mechanically aligned total knee replacements: two-year clinical results.

              We have previously reported the short-term radiological results of a randomised controlled trial comparing kinematically aligned total knee replacement (TKR) and mechanically aligned TKR, along with early pain and function scores. In this study we report the two-year clinical results from this trial. A total of 88 patients (88 knees) were randomly allocated to undergo either kinematically aligned TKR using patient-specific guides, or mechanically aligned TKR using conventional instruments. They were analysed on an intention-to-treat basis. The patients and the clinical evaluator were blinded to the method of alignment. At a minimum of two years, all outcomes were better for the kinematically aligned group, as determined by the mean Oxford knee score (40 (15 to 48) versus 33 (13 to 48); p = 0.005), the mean Western Ontario McMaster Universities Arthritis index (WOMAC) (15 (0 to 63) versus 26 (0 to 73); p = 0.005), mean combined Knee Society score (160 (93 to 200) versus 137 (64 to 200); p= 0.005) and mean flexion of 121° (100 to 150) versus 113° (80 to 130) (p = 0.002). The odds ratio of having a pain-free knee at two years with the kinematically aligned technique (Oxford and WOMAC pain scores) was 3.2 (p = 0.020) and 4.9 (p = 0.001), respectively, compared with the mechanically aligned technique. Patients in the kinematically aligned group walked a mean of 50 feet further in hospital prior to discharge compared with the mechanically aligned group (p = 0.044). In this study, the use of a kinematic alignment technique performed with patient-specific guides provided better pain relief and restored better function and range of movement than the mechanical alignment technique performed with conventional instruments.
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                Author and article information

                Contributors
                omeralanie@doctors.org.uk
                Journal
                Knee Surg Sports Traumatol Arthrosc
                Knee Surg Sports Traumatol Arthrosc
                Knee Surgery, Sports Traumatology, Arthroscopy
                Springer Berlin Heidelberg (Berlin/Heidelberg )
                0942-2056
                1433-7347
                27 September 2022
                27 September 2022
                2023
                : 31
                : 3
                : 751-759
                Affiliations
                [1 ]GRID grid.411714.6, ISNI 0000 0000 9825 7840, Department of Trauma & Orthopaedic Surgery, , Glasgow Royal Infirmary, ; 84 Castle Street, Glasgow, G4 0SF UK
                [2 ]GRID grid.11984.35, ISNI 0000000121138138, Bioengineering Unit, , University of Strathclyde, Graham Hills Building, ; 50 George Street, Glasgow, G1 1QE UK
                Author information
                http://orcid.org/0000-0001-6716-4155
                Article
                7158
                10.1007/s00167-022-07158-1
                9957903
                36166095
                baa80017-656f-402b-98b4-3bd7722e614f
                © The Author(s) 2022

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

                History
                : 9 June 2022
                : 3 September 2022
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100012630, Zimmer Biomet;
                Categories
                Knee
                Custom metadata
                © The Author(s) under exclusive licence to European Society of Sports Traumatology, Knee Surgery, Arthroscopy (ESSKA) 2023

                Surgery
                knee arthroplasty,randomised controlled trial,computer assisted surgery,em navigation
                Surgery
                knee arthroplasty, randomised controlled trial, computer assisted surgery, em navigation

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