Abstract
Purpose
The purpose was to report detailed patient-reported outcome measures (PROMs) and satisfaction rates for computed tomography (CT)-based custom TKA at minimum follow-up of 2 years. The hypothesis was that custom TKA combined with ‘personalised alignment’ would yield equivalent or better PROMs compared to values reported in systematic reviews and meta-analyses on off-the-shelf (OTS) TKA.
Methods
Of an initial cohort of 150 custom TKAs, four died (unrelated to surgery), one required a revision, and five refused participation, leaving 140 patients for analysis. Patients completed pre- and post-operative PROMs (Oxford Knee Score (OKS), Forgotten Joint Score (FJS), Knee injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster osteoarthritis index (WOMAC)) as well as overall level of satisfaction. Proportions that attained a patient acceptable symptom state (PASS) were calculated for OKS and FJS. Clinical findings were compared to the average scores reported for PROMs in recent systematic reviews and/or meta-analyses on OTS TKA. Descriptive statistics were used to summarise the clinical findings as means, standard deviations (SD) and ranges, or numbers and percentages.
Results
At mean follow-up 33.5 ± 4.5 months, 94% (135/143) were either satisfied or very satisfied. Proportions that achieved PASS were 89% for OKS (120/135), and 85% for FJS (118/139). Median OKS, WOMAC and KOOS Symptoms and Pain scores were all within the 4th quartile of medians reported in systematic reviews and/or meta-analyses.
Conclusions
At a minimum follow-up of two years following custom TKA combined with ‘personalised alignment’, 94% of patients were either satisfied or very satisfied, and the PASS criteria were achieved in 89% for OKS and 85% for FJS, all of which compare favourably to published outcomes of OTS TKA. Direct comparisons to the literature may not be appropriate, however, considering the heterogeneity of patient demographics and alignment techniques. Randomised controlled trials with sufficient statistical power are needed to corroborate these findings and generalise them to unselected TKA patients.
Level of evidence
IV, retrospective cohort study.
Similar content being viewed by others
Data availability
The authors can upon reasonable request provide access to the anonymised raw data.
References
Aït-Si-Selmi T, Marie-Hardy L, O’Loughlin PF, Kobayashi K, Müller JH, Saffarini M, Bonnin MP (2020) Patellar facet ratio affects knee pain, stair climbing and stair descent after TKA without patellar resurfacing. Knee Surg Sports Traumatol Arthrosc 28(12):3796–3804
Ayers DC, Yousef M, Zheng H, Yang W, Franklin PD (2022) The prevalence and predictors of patient dissatisfaction 5-years following primary total knee arthroplasty. J Arthroplasty 37(6s):S121-s128
Beckers L, Müller JH, Daxhelet J, Ratano S, Saffarini M, Aït-Si-Selmi T, Bonnin MP (2021) Considerable inter-individual variability of tibial geometric ratios renders bone-implant mismatch unavoidable using off-the-shelf total knee arthroplasty: a systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc. https://doi.org/10.1007/s00167-021-06623-7
Beckers L, Müller JH, Daxhelet J, Saffarini M, Aït-Si-Selmi T, Bonnin MP (2022) Sexual dimorphism and racial diversity render bone-implant mismatch inevitable after off-the-shelf total knee arthroplasty: a systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc 30(3):809–821
Bonnin MP, Beckers L, Leon A, Chauveau J, Müller JH, Tibesku CO, Aït-Si-Selmi T (2022) Custom total knee arthroplasty facilitates restoration of constitutional coronal alignment. Knee Surg Sports Traumatol Arthrosc 30(2):464–475
Bonnin MP, Saffarini M, Bossard N, Dantony E, Victor J (2016) Morphometric analysis of the distal femur in total knee arthroplasty and native knees. Bone Joint J 98-B(1):49–57
Bonnin MP, Saffarini M, Shepherd D, Bossard N, Dantony E (2016) Oversizing the tibial component in TKAs: incidence, consequences and risk factors. Knee Surg Sports Traumatol Arthrosc 24(8):2532–2540
Butnaru M, Senioris A, Pagenstert G, Müller JH, Saffarini M, Dujardin F, Courage O (2022) Arthroscopic management of unexplained pain following total knee arthroplasty. Arch Orthop Trauma Surg 142(6):1109–1115
Butnaru M, Sigonney G, Müller JH, Senioris A, Saffarini M, Courage O (2020) Wiberg Type III patellae and J-sign during extension compromise outcomes of total knee arthroplasty without patellar resurfacing. Knee 27(3):787–794
Cacciola G, Mancino F, De Meo F, Di Matteo V, Sculco PK, Cavaliere P, Maccauro G, De Martino I (2021) Mid-term survivorship and clinical outcomes of the medial stabilized systems in primary total knee arthroplasty: a systematic review. J Orthop 24:157–164
DeFrance M, Scuderi G (2022) Are 20% of patients actually dissatisfied following total knee arthroplasty? A systematic review of the literature. J Arthroplasty. https://doi.org/10.1016/j.arth.2022.10.011
Deng M, Hu Y, Zhang Z, Zhang H, Qu Y, Shao G (2021) Unicondylar knee replacement versus total knee replacement for the treatment of medial knee osteoarthritis: a systematic review and meta-analysis. Arch Orthop Trauma Surg 141(8):1361–1372
Dobbelaere A, Müller JH, Aït-Si-Selmi T, Gousopoulos L, Saffarini M, Bonnin MP (2022) Sagittal femoral condylar shape varies along a continuum from spherical to ovoid: a systematic review and meta-analysis. Arch Orthop Trauma Surg. https://doi.org/10.1007/s00402-022-04613-z
Elbardesy H, Awad AK, McLeod A, Farahat ST, Sayed SZE, Guerin S, Harty J (2021) Does bicompartmental knee arthroplasty hold an advantage over total knee arthroplasty? Systematic review and meta-analysis. Sicot J 7:38
Gao ZX, Long NJ, Zhang SY, Yu W, Dai YX, Xiao C (2020) Comparison of kinematic alignment and mechanical alignment in total knee arthroplasty: a meta-analysis of randomized controlled clinical trials. Orthop Surg 12(6):1567–1578
Hawker GA, Conner-Spady BL, Bohm E, Dunbar MJ, Jones CA, Ravi B, Noseworthy T, Dick D, Powell J, Paul P, Marshall DA (2021) Patients’ preoperative expectations of total knee arthroplasty and satisfaction with outcomes at one year: a prospective cohort study. Arthritis Rheumatol 73(2):223–231
Heijbel S, A WD, Nilsson KG, Hedström M (2022) Substantial clinical benefit and patient acceptable symptom states of the Forgotten Joint Score 12 after primary knee arthroplasty. Acta Orthop 93:158-163
Hirschmann MT, Hess S, Behrend H, Amsler F, Leclercq V, Moser LB (2019) Phenotyping of hip-knee-ankle angle in young non-osteoarthritic knees provides better understanding of native alignment variability. Knee Surg Sports Traumatol Arthrosc 27(5):1378–1384
Hirschmann MT, Moser LB, Amsler F, Behrend H, Leclercq V, Hess S (2019) Phenotyping the knee in young non-osteoarthritic knees shows a wide distribution of femoral and tibial coronal alignment. Knee Surg Sports Traumatol Arthrosc 27(5):1385–1393
Hirschmann MT, Moser LB, Amsler F, Behrend H, Leclerq V, Hess S (2019) Functional knee phenotypes: a novel classification for phenotyping the coronal lower limb alignment based on the native alignment in young non-osteoarthritic patients. Knee Surg Sports Traumatol Arthrosc 27(5):1394–1402
Ingelsrud LH, Terluin B, Gromov K, Price A, Beard D, Troelsen A (2021) Which Oxford Knee Score level represents a satisfactory symptom state after undergoing a total knee replacement? Acta Orthop 92(1):85–90
Jansen K, Beckert M, Deckard ER, Ziemba-Davis M, Meneghini RM (2020) Satisfaction and functional outcomes in unicompartmental compared with total knee arthroplasty: radiographically matched cohort analysis. JB JS Open Access 5(3):e20.00051
Kim AG, Bernhard Z, Acuña AJ, Wu VS, Kamath AF (2022) Use of intraoperative technology in total knee arthroplasty is not associated with reductions in postoperative pain. Knee Surg Sports Traumatol Arthrosc. https://doi.org/10.1007/s00167-022-07098-w
Kim J, Min KD, Lee BI, Kim JB, Kwon SW, Chun DI, Kim YB, Seo GW, Lee JS, Park S, Choi HS (2020) Comparison of functional outcomes between single-radius and multi-radius femoral components in primary total knee arthroplasty: a meta-analysis of randomized controlled trials. Knee Surg Relat Res 32(1):52
Kornilov N, Lindberg MF, Gay C, Saraev A, Kuliaba T, Rosseland LA, Lerdal A (2018) Higher physical activity and lower pain levels before surgery predict non-improvement of knee pain 1 year after TKA. Knee Surg Sports Traumatol Arthrosc 26(6):1698–1708
Lee DY, Park YJ, Hwang SC, Park JS, Kang DG (2020) No differences in mid- to long-term outcomes of computer-assisted navigation versus conventional total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc 28(10):3183–3192
Li C, Li Z, Shi L, Gao F, Sun W (2021) The short-term effectiveness and safety of second-generation patellofemoral arthroplasty and total knee arthroplasty on isolated patellofemoral osteoarthritis: a systematic review and meta-analysis. J Orthop Surg Res 16(1):358
Lin Y, Chen X, Li L, Li Z, Zhang Y, Fan P (2020) Comparison of patient satisfaction between medial pivot prostheses and posterior-stabilized prostheses in total knee arthroplasty. Orthop Surg 12(3):836–842
Luo Z, Zhou K, Peng L, Shang Q, Pei F, Zhou Z (2020) Correction to: Similar results with kinematic and mechanical alignment applied in total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc 28(6):1736–1741
Luo Z, Zhou K, Peng L, Shang Q, Pei F, Zhou Z (2020) Similar results with kinematic and mechanical alignment applied in total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc 28(6):1720–1735
Marmor S, Renault E, Valluy J, Saffarini M (2019) Over-voluming predicted by pre-operative planning in 24% of total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc 27(5):1544–1551
Moorthy V, Lai MC, Liow MHL, Chen JY, Pang HN, Chia SL, Lo NN, Yeo SJ (2021) Similar postoperative outcomes after total knee arthroplasty with measured resection and gap balancing techniques using a contemporary knee system: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc 29(10):3178–3185
Moret CS, Hirschmann MT, Vogel N, Arnold MP (2021) Customised, individually made total knee arthroplasty shows promising 1-year clinical and patient reported outcomes. Arch Orthop Trauma Surg. https://doi.org/10.1007/s00402-021-04045-1
Müller JH, Liebensteiner M, Kort N, Stirling P, Pilot P, Demey G (2021) No significant difference in early clinical outcomes of custom versus off-the-shelf total knee arthroplasty: a systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc. https://doi.org/10.1007/s00167-021-06678-6
Naal FD, Impellizzeri FM, Lenze U, Wellauer V, von Eisenhart-Rothe R, Leunig M (2015) Clinical improvement and satisfaction after total joint replacement: a prospective 12-month evaluation on the patients’ perspective. Qual Life Res 24(12):2917–2925
Neginhal V, Kurtz W, Schroeder L (2020) Patient satisfaction, functional outcomes, and survivorship in patients with a customized posterior-stabilized total knee replacement. JBJS Rev 8(7):e1900104
Nielsen CS, Nebergall A, Huddleston J, Kallemose T, Malchau H, Troelsen A (2018) Medial overhang of the tibial component is associated with higher risk of inferior knee injury and osteoarthritis outcome score pain after knee replacement. J Arthroplasty 33(5):1394–1398
Qin Y, Pu C, Zhou Y, Yu J, Tang J (2021) Influence of patellar denervation on anterior knee pain and knee function following total knee replacement: a systematic review and meta-analysis. ANZ J Surg 91(11):E690-e695
Ratano S, Müller JH, Daxhelet J, Beckers L, Bondoux L, Tibesku CO, Aït-Si-Selmi T, Bonnin MP (2022) Custom TKA combined with personalised coronal alignment yield improvements that exceed KSS substantial clinical benefits. Knee Surg Sports Traumatol Arthrosc 30(9):2958–2965
Reimann P, Brucker M, Arbab D, Lüring C (2019) Patient satisfaction—a comparison between patient-specific implants and conventional total knee arthroplasty. J Orthop 16(3):273–277
Rudran B, Magill H, Ponugoti N, Williams A, Ball S (2022) 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 23(1):702
Sun X, Gao X, Sun X, Su Z (2021) Comparison of clinical and radiographic results between total knee arthroplasties using medial pivot and posterior-stabilized prosthesis: a meta-analysis. Medicine (Baltimore) 100(4):e23809
Tso R, Smith J, Doma K, Grant A, McEwen P (2021) Clinical and patient-reported outcomes of medial stabilized versus non-medial stabilized prostheses in total knee arthroplasty: a systematic review and meta-analysis. J Arthroplasty 36(2):767-776.e762
Vishwanathan K, Kambhampati SBS, Vaishya R (2022) Equivalent outcomes of ultra-congruent and standard cruciate-retaining inserts in total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc 30(9):3076–3091
Wendelspiess S, Kaelin R, Vogel N, Rychen T, Arnold MP (2022) No difference in patient-reported satisfaction after 12 months between customised individually made and off-the-shelf total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc 30(9):2948–2957
Wheatley B, Nappo K, Fisch J, Rego L, Shay M, Cannova C (2019) Early outcomes of patient-specific posterior stabilized total knee arthroplasty implants. J Orthop 16(1):14–18
White PB, Ranawat AS (2016) Patient-specific total knees demonstrate a higher manipulation rate compared to “Off-the-shelf implants.” J Arthroplasty 31(1):107–111
Wood TJ, Winemaker MJ, Williams DS, Petruccelli DT, Tushinski DM, de Beer JV (2021) Randomized controlled trial of sensor-guided knee balancing compared to standard balancing technique in total knee arthroplasty. J Arthroplasty 36(3):953–957
Zaffagnini S, Di Paolo S, Meena A, Alesi D, Zinno R, Barone G, Pizza N, Bragonzoni L (2021) Causes of stiffness after total knee arthroplasty: a systematic review. Int Orthop 45(8):1983–1999
Acknowledgements
ReSurg collaborators: Jacobus H. Müller, MScEng, PhD, cobus@resurg.com. Sonia Dubreuil, MSc, sdubreuil01@gmail.com. Mo Saffarini MEng MBA, journals@resurg.com.
Funding
This work was supported by ‘GCS Ramsay Santé pour l’Enseignement et la Recherche’, which provided funding for data collection and manuscript preparation. This work was also supported by Symbios for statistical analysis.
Author information
Authors and Affiliations
Consortia
Ethics declarations
Conflict of interest
LG, AD, SR, LB, JHM, SD, MS has nothing to disclose. COT reports personal fees from Symbios during the conduct of the study; personal fees from Smith & Nephew outside the submitted work. TASS reports personal fees from Symbios during the conduct of the study; reports personal fees from DePuy-Synthes outside the submitted work. MPB reports personal fees from Symbios during the conduct of the study; reports personal fees from Wright Medical, Integra, DePuy Synthesis outside the submitted work.
Ethical approval
All patients had provided written informed consent for the use of their data and images for research and publishing purposes and the institutional review board of Ramsay Santé pour l’Enseignement et la Recherche approved the study in advance (IRB reference number: COS-RGDS-2021-03-004-BONNIN-M).
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.
About this article
Cite this article
Gousopoulos, L., Dobbelaere, A., Ratano, S. et al. Custom total knee arthroplasty combined with personalised alignment grants 94% patient satisfaction at minimum follow-up of 2 years. Knee Surg Sports Traumatol Arthrosc 31, 1276–1283 (2023). https://doi.org/10.1007/s00167-023-07318-x
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00167-023-07318-x