Is the French Paradox cementing philosophy superior to the standard cementing? A randomized controlled radiostereometric trial and comparative analysis

Kirsti Sevaldsen, Otto Schnell Husby, Øystein Bjerkestrand Lian, Kamel Mohamed Farran, Vigdis Schnell Husby, Kirsti Sevaldsen, Otto Schnell Husby, Øystein Bjerkestrand Lian, Kamel Mohamed Farran, Vigdis Schnell Husby

Abstract

Aims: Highly polished stems with force-closed design have shown satisfactory clinical results despite being related to relatively high early migration. It has been suggested that the minimal thickness of cement mantles surrounding the femoral stem should be 2 mm to 4 mm to avoid aseptic loosening. The line-to-line cementing technique of the femoral stem, designed to achieve stem press-fit, challenges this opinion. We compared the migration of a highly polished stem with force-closed design by standard and line-to-line cementing to investigate whether differences in early migration of the stems occur in a clinical study.

Methods: In this single-blind, randomized controlled, clinical radiostereometric analysis (RSA) study, the migration pattern of the cemented Corail hip stem was compared between line-to-line and standard cementing in 48 arthroplasties. The primary outcome measure was femoral stem migration in terms of rotation and translation around and along with the X-, Y-, and Z- axes measured using model-based RSA at three, 12, and 24 months. A linear mixed-effects model was used for statistical analysis.

Results: Results from mixed model analyses revealed a lower mean retroversion for line-to-line (0.72° (95% confidence interval (CI) 0.38° to 1.07°; p < 0.001), but no significant differences in subsidence between the techniques (-0.15 mm (95% CI -0.53 to 0.227; p = 0.429) at 24 months. Radiolucent lines measuring < 2 mm wide were found in three and five arthroplasties cemented by the standard and line-to-line method, respectively.

Conclusion: The cemented Corail stem with a force-closed design seems to settle earlier and better with the line-to-line cementing method, although for subsidence the difference was not significant. However, the lower rate of migration into retroversion may reduce the wear and cement deformation, contributing to good long-term fixation and implant survival. Cite this article: Bone Joint J 2022;104-B(1):19-26.

Keywords: Cementing technique; Clinical Trials; Corail stem; Force-closed stem design; French paradox; Hip replacement; Migration pattern; RSA; Radiolucent lines; THA; Taper-slip stem design; arthroplasties; aseptic loosening; cementing techniques; femoral stem; hip stems; model-based RSA; radiostereometric analysis (RSA).

Figures

Fig. 1
Fig. 1
CONSORT flowchart. CAD, computer-aided design; CN, condition number; RSA, radiostereometric analysis.
Fig. 2
Fig. 2
Orientation of the migration coordinate system with the Corail stem (DePuy Synthes, USA).
Fig. 3
Fig. 3
Mean retroversion (°) with standard and line-to-line cementing of the Corail stem compared with the precision of rotation around the y-axis. Line-to-line retroversion rate 12 to 24 months: 0.187 (95% confidence interval (CI) -0.031 to 0.404); standard retroversion rate 12 to 24 months: 0.369 (95% CI 0.022° to 0.717).
Fig. 4
Fig. 4
Mean subsidence (mm) with standard and line-to-line cementing of the Corail stem compared with the precision of translation along the y-axis. Line-to-line subsidence rate 12 to 24 months: -0.143 (95% confidence interval (CI) -0.207 to 0.078); standard subsidence rate 12 to 24 months: -0.287 (95% CI -0.475 to -0.099).

References

    1. Langlais F, Kerboull M, Sedel L, Ling RSM. The “French Paradox.” J Bone Joint Surg Br. 2003;85-B(1):17–20.
    1. El Masri F, Kerboull L, Kerboull M, Courpied JP, Hamadouche M. Is the so-called “French Paradox” a reality?: long-term survival and migration of the Charnley-Kerboull stem cemented line-to-line. J Bone Joint Surg Br. 2010;92-B(3):342–348.
    1. Skinner JA, Todo S, Taylor M, Wang JS, Pinskerova V, Scott G. Should the cement mantle around the femoral component be thick or thin? J Bone Joint Surg Br. 2003;85-B(1):45–51.
    1. Kerboull M. L’Arthroplastie Totale de Hanche. Maîtrise Orthopédique. 1999;83:6–10. [Article in French].
    1. Laboudie P, El Masri F, Kerboull L, Hamadouche M. Short vs standard-length femoral stems cemented according to the “French Paradox”: a matched paired prospective study using ein bild roentgen analyze femoral component at two-year follow-up. J Arthroplasty. 2021;36(3):1043–1048.
    1. Janssen D, van Aken J, Scheerlinck T, Verdonschot N. The “French Paradox” exposed: a finite element analysis of cement philosophy on implant stability and crack formation in the cement mantle. Trans Orthop Res Soc. 2007;32:280.
    1. Sevaldsen K, Schnell-Husby O, Lain ØB, Schnell-Husby V. Does the line-to-line cementing technique of the femoral stem create an adequate cement mantle? Hip Int. 2020. 1120700020934368
    1. Huiskes R, Verdonschot N, Nivbrant B. Migration, stem shape, and surface finish in cemented total hip arthroplasty. Clin Orthop Relat Res. 1998;355:103–112.
    1. Scheerlinck T, Casteleyn PP. The design features of cemented femoral hip implants. J Bone Joint Surg Br. 2006;88-B(11):1409–1418.
    1. Clauss M, Breusch SJ. The “French paradox” may not be a paradox after all - but for what reason? Bone Joint Res. 2019;8(1):1–2.
    1. Breusch S, Malchau H. The Well-Cemented Total Hip Arthroplasty. Berlin, Heidelberg: Springer. 2005.
    1. Numata Y, Kaneuji A, Kerboull L, et al. . Biomechanical behaviour of a French femoral component with thin cement mantle: The ‘French paradox’ may not be a paradox after all. Bone Joint Res. 2018;7(7):485–493.
    1. Valstar ER, Gill R, Ryd L, Flivik G, Börlin N, Kärrholm J. Guidelines for standardization of radiostereometry (RSA) of implants. Acta Orthop. 2005;76(4):563–572.
    1. Karrholm J, Borssen B, Lowenhielm G, Snorrason F. Does early micromotion of femoral stem prostheses matter? 4-7-year stereoradiographic follow-up of 84 cemented prostheses. J Bone Joint Surg Br. 76-B(6):912–917.
    1. Hauptfleisch J, Glyn-Jones S, Beard DJ, Gill HS, Murray DW. The premature failure of the Charnley Elite-plus stem: A confirmation of RSA predictions. J Bone Joint Surg Br. 88-B(2):179–183.
    1. Nieuwenhuijse MJ, Valstar ER, Kaptein BL, Nelissen RG. Good diagnostic performance of early migration as a predictor of late aseptic loosening of acetabular cups: results from ten years of follow-up with Roentgen stereophotogrammetric analysis (RSA). J Bone Joint Surg Am. 2012;94-A(10):874–880.
    1. Pijls BG, Nieuwenhuijse MJ, Schoones JW, Middeldorp S, Valstar ER, Nelissen RGHH. RSA prediction of high failure rate for the uncoated interAx TKA confirmed by meta-analysis. Acta Orthop. 2012;83(2):142–147.
    1. Ryd L, Albrektsson B, Carlsson L, et al. . Roentgen stereophotogrammetric analysis as a predictor of mechanical loosening of knee prostheses. J Bone Joint Surg Br. 1995;77-B(3):377–383.
    1. van der Voort P, Pijls BG, Nieuwenhuijse MJ, et al. . Early subsidence of shape-closed hip arthroplasty stems is associated with late revision. A systematic review and meta-analysis of 24 RSA studies and 56 survival studies. Acta Orthop. 2015;86(5):575–585.
    1. Hardinge K. The direct lateral approach to the hip. J Bone Joint Surg Br. 1982;64-B(1):17–19.
    1. Furnes O, Engesæther L, Hallan G, et al. . 2017 Annual Report. Norwegian National Advisory Unit on Arthroplasty and Hip Fractures. 2017. (date last accessed 23 November 2021).
    1. Kärrholm J, Rogmark C, Nauclér E, et al. . Swedish Hip Arthroplasty Register Annual Report 2019. Swedish Hip Arthroplasty Register. 2019. 10.18158/H1BdmrOWu (date last accessed 10 November 2021).
    1. Söderlund P, Dahl J, Röhrl S, Nivbrant B, Nilsson KG. 10-year results of a new low-monomer cement. Acta Orthop. 2012;83(6):604–608.
    1. Nivbrant B, Kärrholm J, Röhrl S, Hassander H, Wesslén B. Bone cement with reduced proportion of monomer in total hip arthroplasty: preclinical evaluation and randomized study of 47 cases with 5 years’ follow-up. Acta Orthop Scand. 2001;72(6):572–584.
    1. Gallart X, Martínez F, García S, et al. . Radiologic evaluation of the cement mantle in the femoral shaft. A comparative study using a fast-set or a standard-set cement. Hip Int. 2007;17(4):205–211.
    1. World Medical Association . World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191–2194.
    1. Kaptein BL, Valstar ER, Spoor CW, Stoel BC, Rozing PM. Model-based RSA of a femoral hip stem using surface and geometrical shape models. Clin Orthop Relat Res. 2006;448:92–97.
    1. Prins AH, Kaptein BL, Stoel BC, Nelissen R, Reiber JHC, Valstar ER. Handling modular hip implants in model-based RSA: Combined stem-head models. J Biomech. 2008;41(14):2912–2917.
    1. Koster LA, Meinardi JE, Kaptein BL, Van der Linden-Van der Zwaag E, Nelissen RGHH. Two-year RSA migration results of symmetrical and asymmetrical tibial components in total knee arthroplasty: A randomized controlled trial. Bone Joint J. 2021;103-B(5):855–863.
    1. van Ooij B, Sierevelt IN, van der Vis HM, Hoornenborg D, Haverkamp D. What is the role of cemented fixation in total knee arthroplasty? The two-year results of a randomized RSA controlled trial. Bone Joint J. 2021;103-B(1):98–104.
    1. Ranstam J, Ryd L, Onsten I. Accurate accuracy assessment: Review of basic principles. Acta Orthop Scand. 1999;70(4):319–321.
    1. No authors listed . ISO 16087: Implants for surgery: Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants. International Organization for Standardization Geneva. 2013. (date last accessed 10 November 2021).
    1. Johnston RC, Fitzgerald RH, Harris WH, Poss R, Müller ME, Sledge CB. Clinical and radiographic evaluation of total hip replacement. A standard system of terminology for reporting results. J Bone Joint Surg Am. 1990;72-A(2):161–168.
    1. Garcia FL, Sugo AT, Picado CHF. Radiographic grading of femoral stem cementation in hip arthroplasty. Acta Ortop Bras. 2013;21(1):30–33.
    1. Barrack RL, Mulroy RD, Harris WH. Improved cementing techniques and femoral component loosening in young patients with hip arthroplasty. A 12-year radiographic review. J Bone Joint Surg Br. 1992;74-B(3):385–389.
    1. Engh CA, Bobyn JD, Glassman AH. Porous-coated hip replacement. The factors governing bone ingrowth, stress shielding, and clinical results. J Bone Joint Surg Br. 1987;69-B(1):45–55.
    1. Gruen TA, McNeice GM, Amstutz HC. “Modes of failure” of cemented stem-type femoral components: a radiographic analysis of loosening. Clin Orthop Relat Res. 1979;141:17–27.
    1. Kobayashi S, Takaoka K, Saito N, Hisa K. Factors affecting aseptic failure of fixation after primary Charnley total hip arthroplasty: multivariate survival analysis. J Bone Joint Surg Am. 1997;79-A(11):1618–1627.
    1. Kärrholm J, Herberts P, Hultmark P, Malchau H, Nivbrant B, Thanner J. Radiostereometry of hip prostheses. Clin Orthop Relat Res. 1997;344(344):94.
    1. Röhrl SM, Nivbrant B, Ström H, Nilsson KG. Effect of augmented cup fixation on stability, wear, and osteolysis: A 5-year follow-up of total hip arthroplasty with RSA. J Arthroplasty. 2004;19(8):962–971.
    1. Pakvis D, Luites J, van Hellemondt G, Spruit M. A cementless, elastic press-fit socket with and without screws. Acta Orthop. 2012;83(5):481–487.
    1. Flatøy B, Röhrl SM, Bøe B, Nordsletten L. No medium-term advantage of electrochemical deposition of hydroxyapatite in cementless femoral stems. 5-year RSA and DXA results from a randomized controlled trial. Acta Orthop. 2016;87(1):42–47.
    1. Alfaro-Adrián J, Gill HS, Murray DW. Should total hip arthroplasty femoral components be designed to subside? A radiostereometric analysis study of the charnley elite and exeter stems. J Arthroplasty. 2001;16(5):598–606.
    1. Alfaro-Adrian J, Gill H, Murray D. Cement migration after THR: a comparison of Charnley Elite and Exeter femoral stems using RSA. J Bone Joint Surg Br. 81-B(1):130–134.
    1. Stefánsdóttir A, Franzén H, Johnsson R, Ornstein E, Sundberg M. Movement pattern of the Exeter femoral stem; a radiostereometric analysis of 22 primary hip arthroplasties followed for 5 years. Acta Orthop Scand. 2004;75(4):408–414.
    1. Sundberg M, Besjakov J, von Schewelow T, Carlsson A. Movement patterns of the C-stem femoral component: An RSA study of 33 primary total hip arthroplasties followed for two years. J Bone Joint Surg Br. 87-B(10):1352–1356.
    1. Murray DW, Gulati A, Gill HS. Ten-year RSA-measured migration of the Exeter femoral stem. Bone Joint J. 2013;95-B(5):605–608.
    1. von Schewelov T, Carlsson A, Sanzén L, Besjakov J. Continuous distal migration and internal rotation of the c-stem prosthesis without any adverse clinical effects: An RSA study of 33 primary total hip arthroplasties followed for up to ten years. Bone Joint J. 2014;96-B(5):604–608.
    1. Chan J, Khoriati AA, Chiang CH, Hadithy NA. Understanding, interpreting and reporting a total hip arthroplasty radiograph. Orthop Muscular Syst. 2017;06(3).
    1. Nieuwenhuijse MJ, Valstar ER, Kaptein BL, Nelissen R. The Exeter femoral stem continues to migrate during its first decade after implantation: 10-12 years of follow-up with radiostereometric analysis (RSA). Acta Orthop. 2012;83(2):129–134.
    1. Carrington NC, Sierra RJ, Gie GA, Hubble MJW, Timperley AJ, Howell JR. The Exeter Universal cemented femoral component at 15 to 17 years: An update on the first 325 hips. J Bone Joint Surg Br. 2009;91-B(6):730–737.
    1. Kiernan S, Hermann KL, Wagner P, Ryd L, Flivik G. The importance of adequate stem anteversion for rotational stability in cemented total hip replacement: A radiostereometric study with ten-year follow-up. Bone Joint J. 2013;95-B(1):23–30.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner