Health technology assessment through Six Sigma Methodology to assess cemented and uncemented protheses in total hip arthroplasty


Submitted: 28 January 2021
Accepted: 12 February 2021
Published: 9 March 2021
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Authors

  • Imma Latessa University Hospital of Naples “Federico II”, Department of Public Health, Naples, Italy; Reykjavík University, Institute for Biomedical and Neural Engineering, Reykjavík, Iceland.
  • Carlo Ricciardi Reykjavík University, Institute for Biomedical and Neural Engineering, Reykjavík, Iceland; University Hospital of Naples ‘Federico II’, Department of Advanced Biomedical Sciences, Naples, Italy. https://orcid.org/0000-0001-7290-6432
  • Deborah Jacob Reykjavík University, Institute for Biomedical and Neural Engineering, Reykjavík, Iceland.
  • Halldór Jónsson Jr University of Iceland, Faculty of Medicine, Reykjavík, Iceland; Landspítali Hospital, Orthopaedic Clinic, Reykjavík, Iceland.
  • Monica Gambacorta Umberto I Hospital, Local Health Unit of Salerno, Salerno, Italy.
  • Giovanni Improta University Hospital of Naples “Federico II”, Department of Public Health, Naples, Italy.
  • Paolo Gargiulo Reykjavík University, Institute for Biomedical and Neural Engineering, Reykjavík, Iceland; Landspítali Hospital, Department of Science, Reykjavík, Iceland.

The purpose of this study is to use Health Technology Assessment (HTA) through the Six Sigma (SS) and DMAIC (Define, Measure, Analyse, Improve, Control) problem-solving strategies for comparing cemented and uncemented prostheses in terms of the costs incurred for Total hip arthroplasty (THA) and the length of hospital stay (LOS). Multinomial logistic regression analysis for modelling the data was also performed. Quantitative parameters extracted from gait analysis, electromyography and computed tomography images were used to compare the approaches, but the analysis did not show statistical significance. The variables regarding costs were studied with the Mann-Whitney and Kruskal-Wallis tests. No statistically significant difference between cemented and uncemented prosthesis for the total cost of LOS was found, but the cost of the surgeon had an influence on the overall expenses, affecting the cemented prosthetic approach. The material costs of surgery for the uncemented prosthesis and the cost of theatre of surgery for the cemented prosthesis were the most influential. Multinomial logistic regression identified the Vastus Lateralis variable as statistically significant. The overall accuracy of the model is 93.0%. The use of SS and DMAIC cycle as tools of HTA proved that the cemented and uncemented approaches for THA have similar costs and LOSy.


Gargiulo P, Edmunds K J, Gíslason M K, Latour C, Hermannsson, Þ, Esposito L, Bifulco P, Cesarelli M, Fraldi M, Cristofolini L, Jónsson Jr H. Patient-specific mobility assessment to monitor recovery after total hip arthroplasty. Proc Inst Mech Eng H. 2018 Oct;232(10):1048-1059. DOI: https://doi.org/10.1177/0954411918797971

Hunt L P, Ben-Shlomo Y, Clark E M, Dieppe P, Judge A, Mac Gregor A J, Tobias J H, Vernon K, Blom AW. 90-day mortality after 409 096 total hip replacements for osteoarthritis, from the National Joint Registry for England and Wales: a retrospective analysis. Lancet. 2013 Sep 28;382(9898):1097-104. DOI: https://doi.org/10.1016/S0140-6736(13)61749-3

Gislason M K, Lupidio F, Jónsson Jr H, Cristofolini L, Esposito L, Bifulco P, Gargiulo P. Three dimensional bone mineral density changes in the femur over 1 year in primary total hip arthroplasty patients. Clin Biomech. (Bristol, Avon) 2020 Aug;78:105092. DOI: https://doi.org/10.1016/j.clinbiomech.2020.105092

Esposito L, Minutolo V, Gargiulo P, Jonsson H, Gislason M K, Fraldi M. Towards an app to estimate patient‐specific perioperative femur fracture risk. Applied Sciences (Switzerland). Appl Sci. 2020; 10, 6409.

Esposito L, Bifulco P, Gargiulo P, Edmunds K, Cutolo A, Cesarelli M, Iuppariello L, Jónsson H, Fraldi M. Towards a patient-specific estimation of intra-operative femoral fracture risk. Comput Methods Biomech Biomed Engin. 2018 Sep;21(12): 663-672. DOI: https://doi.org/10.1080/10255842.2018.1508570

Esposito L, Bifulco P, Gargiulo P, Fraldi M. Singularity-free finite element model of bone through automated voxel-based reconstruction. Comput Methods Biomech Biomed Engin. 2016 Feb;19(3): 257-262. DOI: https://doi.org/10.1080/10255842.2015.1014347

Pakvis D, Biemond L, van Hellemondt G, Spruit M. A cementless elastic monoblock socket in young patients: a ten to 18-year clinical and radiological follow-up. Int Orthop. 2011 Oct;35(10):1445-51. DOI: https://doi.org/10.1007/s00264-010-1120-7

Kallala R, Anderson P, Morris S, Haddad FS. The cost analysis of cemented versus cementless total hip replacement operations on the NHS. Bone Joint J. 2013 Jul;95-B(7):874-6. DOI: https://doi.org/10.1302/0301-620X.95B7.26931

Campbell D, Graham M, Nilsson K G, Wells Vet, Field JR, Callary SA. Early migration characteristics of a hydroxyapatite-coated femoral stem: an RSA study. Int Orthop. 2011 Apr;35(4):483-8. DOI: https://doi.org/10.1007/s00264-009-0913-z

Abdulkarim A, Ellanti P, Motterlini N, Fahey T, O’Byrne. Cemented versus uncemented fixation in total hip replacement: a systematic review and meta-analysis of randomized controlled trials. Orthop Rev (Pavia). 2013 Mar 15;5(1):e8. DOI: https://doi.org/10.4081/or.2013.e8

Wu X D, Tian M, He Y, Chen H, Chen Y, Mishra R, Liu W, Huang W. Short to midterm follow-up of periprosthetic bone mineral density after total hip arthroplasty with the Ribbed anatomic stem. Biomed Res Int. 2019 Jun 27;2019:3085258. DOI: https://doi.org/10.1155/2019/3085258

Hendricks TJ, Chong AC, Cusick RP. The cost of routine follow-up in total joint arthroplasty and the influence of these visits on treatment plans. Kans J Med. 2018 Aug 30;11(3):59-66. eCollection 2018 Aug. DOI: https://doi.org/10.17161/kjm.v11i3.8692

Konan S, Abdel MP, Haddad FS. Cemented versus uncemented hip implant fixation: Should there be age thresholds? Bone Joint Res. 2020 Jan 8;8(12):604-607. DOI: https://doi.org/10.1302/2046-3758.812.BJR-2019-0337

Blythe R, O’Gorman P, Crawford R, Feenan R, Hatton A, Whitehouse S, Graves N. Fixation method for hip arthroplasty stem following hip fracture: A population-level cost-effectiveness analysis. J Arthroplasty. 2020 Jun;35(6):1614-1621. DOI: https://doi.org/10.1016/j.arth.2020.02.001

Biondi M, Crispino M, Improta G, Triassi M. The condroprotector role in the osteoarthritis of the knee. Giornale Italiano di Ortopedia e Traumatologia. 2013; 39:44–47.8.

Improta G, Romano M, Di Cicco MV, Ferraro A, Borrelli A, Verdoliva C, Triassi M, Cesarelli M. Lean thinking to improve emergency department throughput at AORN Cardarelli hospital. BMC Health Serv Res. 2018 Dec 3;18(1):914. DOI: https://doi.org/10.1186/s12913-018-3654-0

D’Addio G, Ricciardi C, Improta G, Bifulco P, Cesarelli M. Feasibility of Machine Learning in Predicting Features Related to Congenital Nystagmus. In: Henriques J., Neves N., de Carvalho P. (eds) XV Mediterranean Conference on Medical and Biological Engineering and Computing – MEDICON 2019. MEDICON 2019. IFMBE Proceedings, vol 76. Springer, Cham. 2020. DOI: https://doi.org/10.1007/978-3-030-31635-8_110

Ricciardi C, Cantoni V, Green R, Improta G, Cesarelli M. Is It Possible to Predict Cardiac Death? In: Henriques J., Neves N., de Carvalho P. (eds) XV Mediterranean Conference on Medical and Biological Engineering and Computing – MEDICON 2019. MEDICON 2019. IFMBE Proceedings, vol 76. Springer, Cham. 2020. DOI: https://doi.org/10.1007/978-3-030-31635-8_101

Stanzione A, Ricciardi C, Cuocolo R, Romeo V, Petrone J, Sarnataro M, Mainenti PP, Improta G, De Rosa F, Insabato L, Brunetti A, Maurea S. MRI Radiomics for the Prediction of Fuhrman Grade in Clear Cell Renal Cell Carcinoma: a Machine Learning Exploratory Study. J Digit Imaging. J Digit Imaging. 2020 Aug;33(4):879-887. DOI: https://doi.org/10.1007/s10278-020-00336-y

Recenti M, Ricciardi C, Gìslason M, Edmunds K, Carraro U, Gargiulo P. Machine Learning Algorithms Predict Body Mass Index Using Nonlinear Trimodal Regression Analysis from Computed Tomography Scans. In: Henriques J., Neves N., de Carvalho P. (eds) XV Mediterranean Conference on Medical and Biological Engineering and Computing – MEDICON 2019. MEDICON 2019. IFMBE Proceedings, vol 76. Springer, Cham. 2020. DOI: https://doi.org/10.1007/978-3-030-31635-8_100

Ricciardi C, Edmunds K J, Recenti M et al. Assessing cardiovascular risks from a mid-thigh CT image: a tree-based machine learning approach using radiodensitometric distributions. Sci Rep. 2020 Feb 18;10(1):2863. DOI: https://doi.org/10.1038/s41598-020-59873-9

Improta G, Ricciardi C, Amato F, D’Addio G, Cesarelli M, Romano M. Efficacy of Machine Learning in Predicting the Kind of Delivery by Cardiotocography. In: Henriques J., Neves N., de Carvalho P. (eds) XV Mediterranean Conference on Medical and Biological Engineering and Computing – MEDICON 2019. MEDICON 2019. IFMBE Proceedings, vol 76. Springer, Cham. 2020. DOI: https://doi.org/10.1007/978-3-030-31635-8_95

Cutti A G, Lettieri E, Verni G. Health Technology Assessment as Theoretical Framework to Assess Lower-Limb Prosthetics—Issues and Opportunities from an International Perspective. In JPO: Journal of Prosthetics and Orthotics (Vol. 31, No. 1S, pp. P55-P73). LWW. 2019. DOI: https://doi.org/10.1097/JPO.0000000000000235

Al-Omar HA, Attuwaijri AA, Aljuffali IA. Pharmaceutical companies’ views on a health technology assessment (HTA) entity in Saudi Arabia. Saudi Pharm J. 2020 Jun;28(6):662-668. DOI: https://doi.org/10.1016/j.jsps.2020.04.006

Ricciardi C, Sorrentino A, Improta G, Abbate V, Latessa I, Perrone A, Dell’Aversana Orabona GA. health technology assessment between two pharmacological therapies through Six Sigma: the case study of bone cancer. The TQM Journal. 2020. DOI: https://doi.org/10.1108/TQM-01-2020-0013

Antony J, Palsuk P, Gupta S, Mishra D, Barach P. Six Sigma in healthcare: a systematic review of the literature. International Journal of Quality & Reliability Management. 2018; 35(5), 1075-1092.

Improta G, Balato G, Romano M, Carpentieri F, Bifulco P, Alessandro Russo M, Rosa D, Triassi M, Cesarelli M. Lean Six Sigma: a new approach to the management of patients undergoing prosthetic hip replacement surgery. J Eval Clin Pract. 2015 Aug;21(4):662-72. DOI: https://doi.org/10.1111/jep.12361

Improta G, Balato G, Romano M, Ponsiglione AM, Raiola E, Russo MA, Cuccaro P, Santillo LC, Cesarelli M. Improving performances of the knee replacement surgery process by applying DMAIC principles. J Eval Clin Pract. 2017 Dec;23(6):1401-1407. DOI: https://doi.org/10.1111/jep.12810

Al Kuwaiti A, Subbarayalu AV. Reducing hospital-acquired infection rate using the Six Sigma DMAIC approach. Saudi J Med Med Sci. Sep-Dec 2017;5(3):260-266.

Improta G, Cesarelli M, Montuori P, Santillo LC, Triassi M.. Reducing the risk of healthcare associated infections through Lean Six Sigma: The case of the medicine areas at the Federico II University Hospital in Naples (Italy). J Eval Clin Pract. 2018 Apr;24(2):338-346. DOI: https://doi.org/10.1111/jep.12844

Improta G, Ricciardi C, Borrelli A, D’alessandro A, Verdoliva C.. Cesarelli M. The application of six sigma to reduce the pre-operative length of hospital stay at the hospital Antonio Cardarelli. International Journal of Lean Six Sigma. 2019; 11 (3): 555-76. DOI: https://doi.org/10.1108/IJLSS-02-2019-0014

Does RJ, van den Heuvel J, De Mast J, Niemeijer G C. Improving quality in healthcare while reducing costs. Quality Management Forum. 2010; 36 (3), 12-15.

D’Andrea M A, Ianni L, Lega F, Sargiacomo M. Lean in healthcare: a comprehensive review. Health policy. 2015 Sept; 119(9), 1197-209.

Huang Y, Li X, Wilck J, Berg T. Cost reduction in healthcare via Lean Six Sigma. In IIE Annual Conference. Proceedings (p. 1). Institute of Industrial and Systems Engineers (IISE). 2012.

Peltokorpi A, Kujala J. Time-based analysis of total cost of patient episodes: a case study of hip replacement. Int J Health Care Qual Assur Inc Leadersh Health Serv. 2006;19(2-3):136-45. DOI: https://doi.org/10.1108/09526860610651672

Ricciardi C, Fiorillo A, Valente AS, Borrelli A, Verdoliva C, Triassi M, Improta G. Lean Six Sigma approach to reduce LOS through a diagnostic-therapeutic-assistance path at A.O.R.N. A. Cardarelli", The TQM Journal. 2019; Vol. 31 No. 5, pp. 657-672.

Improta G, Balato G, Ricciardi C, et al. Lean Six Sigma in healthcare: Fast track surgery for patients undergoing prosthetic hip replacement surgery. The TQM Journal. 2019; Vol. 31 No. 4, pp. 526-540.

Ricciardi C, Balato G, Romano M, Santalucia I, Cesarelli M, Improta G. Fast track surgery for knee replacement surgery: a lean six sigma approach. The TQM Journal. 2019; Vol. ahead-of-print No. ahead-of-print. DOI: https://doi.org/10.1108/TQM-06-2019-0159

Improta G, Guizzi G, Ricciardi C, Giordano V, Ponsiglione A M, Converso G, Triassi M. Agile Six Sigma in Healthcare: Case Study at Santobono Pediatric Hospital. Int J Environ Res Public Health. 2020; 17, 1052.

Heintz S, Gutierrez-Farewik EM. Static optimization of muscle forces during gait in comparison to EMG-to-force processing approach. Gait Posture. 2007 Jul;26(2):279-88. DOI: https://doi.org/10.1016/j.gaitpost.2006.09.074

Pétursson Þ, Magnússon B, Helgason B, Magnúsdóttir G, Halldórsson G, Tribel J, Jónsson Jr H, Gargiulo P. Bone and muscle assessment in patients undergoing total hip arthroplasty using HU based analysis. Eur J Transl Myol. 2015 Mar 11;25(2):4913. DOI: https://doi.org/10.4081/bam.2015.2.101

Çelik T, Mutlu İ, Özkan A, Kişioğlu Y. The effect of cement on hip stem fixation: a biomechanical study. Australas Phys Eng Sci Med. 2017 Jun;40(2):349-357. DOI: https://doi.org/10.1007/s13246-017-0539-1

Junnila M, Laaksonen I, Eskelinen A, Pulkkinen P, Ivar Havelin L, Furnes O, Garellick G. Implant survival of the most common cemented total hip devices from the Nordic Arthroplasty Register Association database. Acta Orthop. 2016 Dec;87(6): 546-553. DOI: https://doi.org/10.1080/17453674.2016.1222804

Maggs J, Wilson M. The relative merits of cemented and uncemented prosthesis in total hip arthroplasty. Indian J Orthop. Jul-Aug 2017;51(4):377-385.

Meding JB, Ritter MA, Davis KE, Hillery. Cemented and uncemented total hip arthroplasty using the same femoral component. Hip Int. Jan-Feb 2016;26(1):62-6.

Rolfson O, Donahue GS, Hallsten M, Garellick G, Kärrholm J, Nemes S. Patient-reported outcomes in cemented and uncemented total hip replacements. Hip Int. 2016 Sep 29;26(5):451-457. DOI: https://doi.org/10.5301/hipint.5000371

Yang C, Han X, Wang J, Yuan Z, Wang T, Zhao M, Han G. Cemented versus uncemented femoral component total hip arthroplasty in elderly patients with primary osteoporosis: retrospective analysis with 5-year follow-up. J Int Med Res. 2019 Apr;47(4):1610-1619. DOI: https://doi.org/10.1177/0300060518825428

Temporiti F, Zanotti G, Furone R, Molinari S, Zago M, Loppini M, Galli M, Grappiolo G, Gatti R. Gait analysis in patients after bilateral versus unilateral total hip arthroplasty. Gait Posture. 2019 Jul;72:46-50. DOI: https://doi.org/10.1016/j.gaitpost.2019.05.026

Ricciardi C, Jónsson H, Jacob D, Improta G, Recenti M, Gíslason MK, Cesarelli G, Esposito L, Minutolo V, Bifulco P, Gargiulo P. Improving Prosthetic Selection and Predicting BMD from Biometric Measurements in Patients Receiving Total Hip Arthroplasty. Diagnostics (Basel). 2020 Oct 14;10(10):815. DOI: https://doi.org/10.3390/diagnostics10100815

Latessa, I., Ricciardi, C., Jacob, D., Jónsson Jr, H., Gambacorta, M., Improta, G., & Gargiulo, P. (2021). Health technology assessment through Six Sigma Methodology to assess cemented and uncemented protheses in total hip arthroplasty. European Journal of Translational Myology, 31(1). https://doi.org/10.4081/ejtm.2021.9651

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