Skip to main content

No significant difference in early clinical outcomes of custom versus off-the-shelf total knee arthroplasty: a systematic review and meta-analysis

Knee Surgery, Sports Traumatology, Arthroscopy (2021)Cite this article

Abstract

Purpose

The purpose of this systematic review and meta-analysis was to collect, synthesise and critically appraise findings of clinical studies that report outcomes of custom total knee arthroplasty (TKA). The hypothesis was that, compared to off-the-shelf (OTS) TKA, custom TKA would yield better surgical, clinical and radiographic outcomes.

Methods

This systematic review and meta-analysis was performed in accordance with the guidelines of Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). On 8 February 2021, two authors independently searched and screened articles using MEDLINE®, Embase® and the Cochrane Library without restriction on date of publication. Findings from eligible articles were narratively synthesised and tabulated, and when ≥ 3 comparative studies reported the same outcome, results were pooled and summarised in forest plots. Quality assessments of the studies were done according to the guidelines of the Joanna Briggs Institute (JBI) Checklists.

Results

A total of 15 articles were eligible for data extraction, of which 9 were case–control studies reporting on 929 custom versus 998 OTS TKA, 5 were case series reporting on results of 587 custom TKA, and 1 was a cross-sectional study reporting on results of 44 custom versus 132 OTS TKA. Five studies that compared early revision rates found the overall effect in favour of OTS TKA (odds ratio (OR), 0.4; p = n.s.) but the result did not reach statistical significance. Four studies found no statistically significant difference in KSS knee (standardised mean difference (SMD), − 0.10; p = n.s.) and function (SMD, 0.03; p = n.s.), and five studies found no statistically significant difference in range of motion (SMD, 0.02; p = n.s.). One study that compared bone–implant fit between custom and three OTS tibial components found no overhang but revealed under-coverage of up to 18% in knees with custom tibial baseplates.

Conclusion

Custom TKA demonstrated no significant benefits compared to OTS TKA in terms of pooled clinical outcomes, but had considerably higher early revision rates. The findings of the present systematic review and meta-analysis suggest the need for studies with better comparable groups and standardisation of reporting outcomes amongst studies, that could increase the quality of evidence and enable pooling of results in future meta-analyses.

Level of evidence

Level IV.

This is a preview of subscription content, access via your institution.

Access options

Buy single article

Instant access to the full article PDF.

USD 39.95

Price includes VAT (USA)
Tax calculation will be finalised during checkout.

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5
Fig. 6

References

  1. Abdel MP, Ollivier M, Parratte S, Trousdale RT, Berry DJ, Pagnano MW (2018) Effect of postoperative mechanical axis alignment on survival and functional outcomes of modern total knee arthroplasties with cement: a concise follow-up at 20 years. J Bone Joint Surg Am 100(6):472–478

    PubMed  Article  Google Scholar 

  2. Arbab D, Reimann P, Brucker M, Bouillon B, Lüring C (2018) Alignment in total knee arthroplasty—a comparison of patient-specific implants with the conventional technique. Knee 25(5):882–887

    PubMed  Article  Google Scholar 

  3. Arnholdt J, Kamawal Y, Horas K, Holzapfel BM, Gilbert F, Ripp A, Rudert M, Steinert AF (2020) Accurate implant fit and leg alignment after cruciate-retaining patient-specific total knee arthroplasty. BMC Musculosk Disord 21(1):699

    Article  Google Scholar 

  4. Batailler C, Swan J, Sappey Marinier E, Servien E, Lustig S (2021) New technologies in knee arthroplasty: current concepts. J Clin Med 10(1):1–18

    Google Scholar 

  5. Beckers L, Müller JH, Daxhelet J, Saffarini M, Aït-Si-Selmi T, Bonnin MP (2021) 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. https://doi.org/10.1007/s00167-021-06447-5

    Article  PubMed  Google Scholar 

  6. Beit Ner E, Dosani S, Biant LC, Tawy GF (2021) Custom implants in TKA provide no substantial benefit in terms of outcome scores, reoperation risk, or mean alignment: a systematic review. Clin Orthop Relat Res. https://doi.org/10.1097/corr.0000000000001651

    Article  PubMed  PubMed Central  Google Scholar 

  7. Bonnin MP, Beckers L, Leon A, Chauveau J, Müller JH, Tibesku CO, Aït-Si-Selmi T (2020) Custom total knee arthroplasty facilitates restoration of constitutional coronal alignment. Knee Surg Sports Traumatol Arthrosc. https://doi.org/10.1007/s00167-020-06153-8

    Article  PubMed  PubMed Central  Google Scholar 

  8. Bonnin MP, de Kok A, Verstraete M, Van Hoof T, Van Der Straten C, Saffarini M, Victor J (2017) Popliteus impingement after TKA may occur with well-sized prostheses. Knee Surg Sports Traumatol Arthrosc 25(6):1720–1730

    PubMed  Article  Google Scholar 

  9. Brooks F, Akram T, Roy S, Pemberton D, Chandatreya A (2012) Early results with a patient specific interpositional knee device. Acta Orthop Belg 78(4):500–505

    PubMed  Google Scholar 

  10. Cheng T, Zhu C, Wang J, Cheng M, Peng X, Wang Q, Zhang X (2014) No clinical benefit of gender-specific total knee arthroplasty. Acta Orthop 85(4):415–421

    PubMed  PubMed Central  Article  Google Scholar 

  11. Clary C, Aram L, Deffenbaugh D, Heldreth M (2014) Tibial base design and patient morphology affecting tibial coverage and rotational alignment after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc 22(12):3012–3018

    PubMed  PubMed Central  Article  Google Scholar 

  12. Culler SD, Martin GM, Swearingen A (2017) Comparison of adverse events rates and hospital cost between customized individually made implants and standard off-the-shelf implants for total knee arthroplasty. Arthroplasty Today 3(4):257–263

    PubMed  PubMed Central  Article  Google Scholar 

  13. Dejour D, Ntagiopoulos PG, Saffarini M (2014) Evidence of trochlear dysplasia in femoral component designs. Knee Surg Sports Traumatol Arthrosc 22(11):2599–2607

    PubMed  Article  Google Scholar 

  14. 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

    PubMed  PubMed Central  Article  Google Scholar 

  15. Gunaratne R, Pratt DN, Banda J, Fick DP, Khan RJK, Robertson BW (2017) Patient dissatisfaction following total knee arthroplasty: a systematic review of the literature. J Arthroplasty 32(12):3854–3860

    PubMed  Article  Google Scholar 

  16. Gustke KA, Golladay GJ, Roche MW, Elson LC, Anderson CR (2017) A targeted approach to ligament balancing using kinetic sensors. J Arthroplasty 32(7):2127–2132

    PubMed  Article  Google Scholar 

  17. Higgins JP, Thompson SG, Deeks JJ, Altman DG (2003) Measuring inconsistency in meta-analyses. BMJ 327(7414):557–560

    PubMed  PubMed Central  Article  Google Scholar 

  18. Hitt K, Shurman JR 2nd, Greene K, McCarthy J, Moskal J, Hoeman T, Mont MA (2003) Anthropometric measurements of the human knee: correlation to the sizing of current knee arthroplasty systems. J Bone Joint Surg Am 85-A(Suppl 4):115–122

    Article  Google Scholar 

  19. Kaelin R, Vogel N, Arnold MP (2019) Clinical and patient-reported short-term results after customized individually made total knee arthroplasty. Swiss Med Wkly 149:62S

    Google Scholar 

  20. Kim TK, Phillips M, Bhandari M, Watson J, Malhotra R (2017) What differences in morphologic features of the knee exist among patients of various races? A systematic review. Clin Orthop 475(1):170–182

    CAS  PubMed  Article  Google Scholar 

  21. Kumar P, Elfrink J, Daniels JP, Aggarwal A, Keeney JA (2020) Higher component malposition rates with patient-specific cruciate retaining tka than contemporary posterior stabilized TKA. J Knee Surg. https://doi.org/10.1055/s-0040-1701453

    Article  PubMed  Google Scholar 

  22. Lee J-A, Koh Y-G, Kang K-T (2020) Biomechanical and clinical effect of patient-specific or customized knee implants: a review. J Clin Med. https://doi.org/10.3390/jcm9051559

    Article  PubMed  PubMed Central  Google Scholar 

  23. Lei K, Liu L, Chen X, Feng Q, Yang L, Guo L (2021) Navigation and robotics improved alignment compared with PSI and conventional instrument, while clinical outcomes were similar in TKA: a network meta-analysis. Knee Surg Sports Traumatol Arthrosc. https://doi.org/10.1007/s00167-021-06436-8

    Article  PubMed  Google Scholar 

  24. Levengood GA, Dupee J (2018) Accuracy of coronal plane mechanical alignment in a customized, individually made total knee replacement with patient-specific instrumentation. J Knee Surg 31(8):792–796

    PubMed  Article  Google Scholar 

  25. Li K, Saffarini M, Valluy J, Desseroit MC, Morvan Y, Telmon N, Cavaignac E (2019) Sexual and ethnic polymorphism render prosthetic overhang and under-coverage inevitable using off-the shelf TKA implants. Knee Surg Sports Traumatol Arthrosc 27(7):2130–2139

    PubMed  Article  Google Scholar 

  26. Liu HX, Shang P, Ying XZ, Zhang Y (2016) Shorter survival rate in varus-aligned knees after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc 24(8):2663–2671

    PubMed  Article  Google Scholar 

  27. Lombardi AV Jr, Berend KR, Adams JB (2008) Patient-specific approach in total knee arthroplasty. Orthopedics 31(9):927–930

    PubMed  Google Scholar 

  28. Matar HE, Platt SR, Gollish JD, Cameron HU (2020) Overview of randomized controlled trials in total knee arthroplasty (47,675 Patients): what have we learnt? J Arthroplasty 35(6):1729-1736.e1721

    PubMed  Article  Google Scholar 

  29. Meccia IM, Cates BA, Kurtz HE, Anderle WB, Komistek MR (2016) In vivo kinematics for customized vs. traditional TKA designs: a mobile fluoroscopy study. J Orthop Res 34:0928

    Google Scholar 

  30. Meheux CJ, Park KJ, Clyburn TA (2019) A retrospective study comparing a patient-specific design total knee arthroplasty with an off-the-shelf design: unexpected catastrophic failure seen in the early patient-specific design. J Am Acad Orthop Surg Glob Res Rev 3(11):e10.5435

    PubMed  PubMed Central  Google Scholar 

  31. Mihalko W, Fishkin Z, Krackow K (2006) Patellofemoral overstuff and its relationship to flexion after total knee arthroplasty. Clin Orthop 449:283–287

    PubMed  Article  Google Scholar 

  32. Moola S, Munn Z, Tufanaru C, Aromataris E, Sears K, Sfetcu R, Currie M, Qureshi R, Mattis P, Lisy K, Mu P-F (2020) Chapter 7: systematic reviews of etiology and risk. In: Aromataris E, Munn Z (eds) JBI manual for evidence synthesis. JBI. https://doi.org/10.46658/JBIMES-46620-46608

    Chapter  Google Scholar 

  33. Moret CS, Schelker BL, Hirschmann MT (2021) Clinical and radiological outcomes after knee arthroplasty with patient-specific versus off-the-shelf knee implants: a systematic review. J Pers Med. https://doi.org/10.3390/jpm11070590

    Article  PubMed  PubMed Central  Google Scholar 

  34. Namin AT, Jalali MS, Vahdat V, Bedair HS, O’Connor MI, Kamarthi S, Isaacs JA (2019) Adoption of new medical technologies: the case of customized individually made knee implants. Value Health 22(4):423–430

    PubMed  Article  Google Scholar 

  35. Namin AT, Vahdat V, DiGennaro C, Amid R, Jalali MS (2020) Adoption of new medical technologies: the effects of insurance coverage vs continuing medical education. Health Policy Technol 9(1):39–41

    Article  Google Scholar 

  36. 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

    PubMed  Article  Google Scholar 

  37. O’Connor MI, Blau BE (2019) The economic value of customized versus off-the-shelf knee implants in medicare fee-for-service beneficiaries. Am Health Drug Benefits 12(2):66–73

    PubMed  PubMed Central  Google Scholar 

  38. Okazaki Y, Pujol N (2020) The use of an asymmetrical tibial tray in TKA optimises tibial rotation when fitted to the posterior tibial plateau border. Knee Surg Sports Traumatol Arthrosc 28(12):3821–3826

    PubMed  Article  Google Scholar 

  39. Rand JA (1997) Custom and modular total knee arthroplasty. Am J Knee Surg 10(1):49–52

    CAS  PubMed  Google Scholar 

  40. 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

    PubMed  PubMed Central  Article  Google Scholar 

  41. Saffarini M, Demey G, Nover L, Dejour D (2016) Evolution of trochlear compartment geometry in total knee arthroplasty. Ann Transl Med 4(1):1–6

    Google Scholar 

  42. Sappey-Marinier E, Swan J, Batailler C, Servien E, Lustig S (2020) No clinical benefit from gender-specific total knee replacement implants: a systematic review. SICOT J 6:25

    PubMed  PubMed Central  Article  Google Scholar 

  43. Schroeder L, Martin G (2019) In vivo tibial fit and rotational analysis of a customized, patient-specific TKA versus off-the-shelf TKA. J Knee Surg 32(6):499–505

    PubMed  Article  Google Scholar 

  44. Schwarzkopf R, Brodsky M, Garcia GA, Gomoll AH (2015) Surgical and functional outcomes in patients undergoing total knee replacement with patient-specific implants compared with “off-the-shelf” implants. Orthop J Sports Med 3(7):2325967115590379

    PubMed  PubMed Central  Article  Google Scholar 

  45. Schwechter EM, Fitz W (2012) Design rationale for customized TKA: a new idea or revisiting the past. Curr Rev Musculoskelet Med 5(4):303–308

    PubMed  PubMed Central  Article  Google Scholar 

  46. Shekhar A, Chandra Krishna C, Patil S, Tapasvi S (2020) Does increased femoral component size options reduce anterior femoral notching in total knee replacement? J Clin Orthop Trauma 11(Suppl 2):S223-s227

    PubMed  Article  Google Scholar 

  47. Simsek ME, Gursoy S, Akkaya M, Kapicioglu MIS, Bozkurt M (2020) Radiographs are not sufficient for evaluation of component fit in subtle knee pain after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc 28(6):2015–2022

    PubMed  Article  Google Scholar 

  48. Steinert AF, Kamawal Y, Arnholdt J, Holzapfel B, Ripp A, Rudert M (2016) Early radiological results after total knee arthroplasty using patient-specific instruments and implants (iTotalTM). Osteoarthr Cartil 24:S518

    Article  Google Scholar 

  49. Steinert AF, Sefrin L, Jansen B, Schröder L, Holzapfel BM, Arnholdt J, Rudert M (2020) Patient-specific cruciate-retaining total knee replacement with individualized implants and instruments (iTotalTM CR G2). Oper Orthop Traumatol. https://doi.org/10.1007/s00064-020-00690-8

    Article  PubMed  Google Scholar 

  50. Tanaka Y, Nakamura S, Kuriyama S, Nishitani K, Ito H, Lyman S, Matsuda S (2020) Intraoperative physiological lateral laxity in extension and flexion for varus knees did not affect short-term clinical outcomes and patient satisfaction. Knee Surg Sports Traumatol Arthrosc. https://doi.org/10.1007/s00167-020-05862-4

    Article  PubMed  Google Scholar 

  51. 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

    PubMed  Article  Google Scholar 

  52. 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

    PubMed  Article  Google Scholar 

  53. Zeller IM, Kurtz WB, Ta MD, Dessinger GM, Sharma A, Komistek RD (2017) In-vivo kinematics for patients implanted with a customized, patient-specific posterior stabilized total knee arthroplasty vs traditional patient sized off-The-shelf TKA during activities of daily living. Knee 24(6):VIII

    Article  Google Scholar 

  54. Zeller IM, Sharma A, Kurtz WB, Anderle MR, Komistek RD (2017) Customized versus patient-sized cruciate-retaining total knee arthroplasty: an in vivo kinematics study using mobile fluoroscopy. J Arthroplasty 32(4):1344–1350

    PubMed  Article  Google Scholar 

Download references

Acknowledgements

The authors are grateful to Luca Nover for assistance with data extraction. The authors also gratefully acknowledge the contribution of Mo Saffarini, M.Eng, MBA, FRSM, (Mail: mo@resurg.com, Orcid: http://orcid.org/0000-0002-9656-987X). ReSurg SA, Nyon, Switzerland; Markus P Arnold, MD, PhD, Practice LEONARDO, Hirslanden Klinik Birshof, Münchenstein, Switzerland; Faculty of Medicine, University of Basel, Basel, Switzerland. Johannes Beckmann, MD, PhD, 8.Sportklinik Stuttgart, Taubenheimstr. 8, 70372, Stuttgart, Germany.

European Knee Associates (EKA)

The contributors of the European Knee Associates (EKA) are: Mo Saffarini; Markus P Arnold: Practice LEONARDO, Hirslanden Klinik Birshof, Münchenstein, Switzerland. Faculty of Medicine, University of Basel, Basel, Switzerland; Johannes Beckmann: Sportklinik Stuttgart, Taubenheimstr. 8, 70372, Stuttgart, Germany.

Funding

The authors are grateful to “GCS Ramsay Santé pour l’Enseignement et la Recherche” for funding the statistical analysis and manuscript preparation for this study.

Author information

Authors and Affiliations

  1. ReSurg SA, Rue Saint-Jean 22, 1260, Nyon, Switzerland

    Jacobus H. Müller & Patrick Stirling

  2. Department of Orthopaedics and Traumatology, Medical University of Innsbruck, Anichstraße 35, 6020, Innsbruck, Austria

    Michael Liebensteiner

  3. CortoClinics, Schijndel, The Netherlands

    Nanne Kort

  4. IMUKA, Roosteren, The Netherlands

    Peter Pilot

  5. Lyon-Ortho-Clinic, Clinique de la Sauvegarde, Ramsay Santé, 29 Avenue des Sources, 69009, Lyon, France

    Guillaume Demey

Authors
  1. Jacobus H. Müller
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Michael Liebensteiner
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Nanne Kort
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Patrick Stirling
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Peter Pilot
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Guillaume Demey
    View author publications

    You can also search for this author in PubMed Google Scholar

Consortia

European Knee Associates (EKA)

  • Mo Saffarini
  • , Markus P. Arnold
  •  & Johannes Beckmann

Contributions

JHM: study design, literature search, data extraction, statistical analysis, manuscript preparation, and project coordination. ML: study design and manuscript enhancement. NK: study design and manuscript fine-tuning. PS: study design, literature search, data extraction, and manuscript preparation. PP: study design and manuscript improvement. GD: study design and manuscript fine-tuning. MS: study design, manuscript enhancement, and project coordination. MPA: study design and manuscript fine-tuning. JB: study design and manuscript fine-tuning.

Ethics declarations

Conflict of interest

JHM, PS, PP, and GD have nothing to disclose. ML reports receiving honoraria from DePuy, and Stryker outside the submitted work. NK reports personal fees from BodyCad, Stryker, Zimmer-Biomet, and Bioventus outside the submitted work. MPA reports being a consultant for ConforMIS and Symbios outside the submitted work. JB reports receiving honoraria from DePuy, Smith + Nephew, and ConforMIS outside the submitted work.

Ethical statement

This was a systematic review and meta-analysis of published results, and therefore, IRB approval was not necessary.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

European Knee Associates (EKA) members are listed in the Acknowledgement section.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Müller, J.H., Liebensteiner, M., Kort, N. et al. 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 (2021). https://doi.org/10.1007/s00167-021-06678-6

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: https://doi.org/10.1007/s00167-021-06678-6

Keywords

  • Arthroplasty
  • Replacement
  • Knee
  • Total knee arthroplasty
  • TKA
  • Custom
  • Patient-specific