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Published in: Knee Surgery, Sports Traumatology, Arthroscopy 4/2023

25-08-2021 | KNEE

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

Authors: Jacobus H. Müller, Michael Liebensteiner, Nanne Kort, Patrick Stirling, Peter Pilot, Guillaume Demey, European Knee Associates (EKA)

Published in: Knee Surgery, Sports Traumatology, Arthroscopy | Issue 4/2023

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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.
Literature
1.
go back to reference 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):472–478PubMedCrossRef 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):472–478PubMedCrossRef
2.
go back to reference 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):882–887PubMedCrossRef 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):882–887PubMedCrossRef
3.
go back to reference 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):699CrossRef 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):699CrossRef
4.
go back to reference 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 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
8.
go back to reference 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):1720–1730PubMedCrossRef 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):1720–1730PubMedCrossRef
9.
go back to reference 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):500–505PubMed 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):500–505PubMed
10.
go back to reference 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):415–421PubMedPubMedCentralCrossRef 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):415–421PubMedPubMedCentralCrossRef
11.
go back to reference 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):3012–3018PubMedPubMedCentralCrossRef 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):3012–3018PubMedPubMedCentralCrossRef
12.
go back to reference 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):257–263PubMedPubMedCentralCrossRef 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):257–263PubMedPubMedCentralCrossRef
13.
go back to reference Dejour D, Ntagiopoulos PG, Saffarini M (2014) Evidence of trochlear dysplasia in femoral component designs. Knee Surg Sports Traumatol Arthrosc 22(11):2599–2607PubMedCrossRef Dejour D, Ntagiopoulos PG, Saffarini M (2014) Evidence of trochlear dysplasia in femoral component designs. Knee Surg Sports Traumatol Arthrosc 22(11):2599–2607PubMedCrossRef
14.
go back to reference 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):1567–1578PubMedPubMedCentralCrossRef 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):1567–1578PubMedPubMedCentralCrossRef
15.
go back to reference 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):3854–3860PubMedCrossRef 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):3854–3860PubMedCrossRef
16.
go back to reference Gustke KA, Golladay GJ, Roche MW, Elson LC, Anderson CR (2017) A targeted approach to ligament balancing using kinetic sensors. J Arthroplasty 32(7):2127–2132PubMedCrossRef Gustke KA, Golladay GJ, Roche MW, Elson LC, Anderson CR (2017) A targeted approach to ligament balancing using kinetic sensors. J Arthroplasty 32(7):2127–2132PubMedCrossRef
18.
go back to reference 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):115–122CrossRef 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):115–122CrossRef
19.
go back to reference 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 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
20.
go back to reference 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):170–182PubMedCrossRef 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):170–182PubMedCrossRef
24.
go back to reference 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):792–796PubMedCrossRef 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):792–796PubMedCrossRef
25.
go back to reference 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):2130–2139PubMedCrossRef 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):2130–2139PubMedCrossRef
26.
go back to reference 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):2663–2671PubMedCrossRef 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):2663–2671PubMedCrossRef
27.
go back to reference Lombardi AV Jr, Berend KR, Adams JB (2008) Patient-specific approach in total knee arthroplasty. Orthopedics 31(9):927–930PubMed Lombardi AV Jr, Berend KR, Adams JB (2008) Patient-specific approach in total knee arthroplasty. Orthopedics 31(9):927–930PubMed
28.
go back to reference 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.e1721PubMedCrossRef 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.e1721PubMedCrossRef
29.
go back to reference 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 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
30.
go back to reference 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):e10.5435PubMedPubMedCentral 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):e10.5435PubMedPubMedCentral
31.
go back to reference Mihalko W, Fishkin Z, Krackow K (2006) Patellofemoral overstuff and its relationship to flexion after total knee arthroplasty. Clin Orthop 449:283–287PubMedCrossRef Mihalko W, Fishkin Z, Krackow K (2006) Patellofemoral overstuff and its relationship to flexion after total knee arthroplasty. Clin Orthop 449:283–287PubMedCrossRef
34.
go back to reference 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):423–430PubMedCrossRef 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):423–430PubMedCrossRef
35.
go back to reference 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):39–41CrossRef 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):39–41CrossRef
36.
go back to reference 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):e1900104PubMedCrossRef 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):e1900104PubMedCrossRef
37.
go back to reference 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):66–73PubMedPubMedCentral 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):66–73PubMedPubMedCentral
38.
go back to reference 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):3821–3826PubMedCrossRef 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):3821–3826PubMedCrossRef
39.
go back to reference Rand JA (1997) Custom and modular total knee arthroplasty. Am J Knee Surg 10(1):49–52PubMed Rand JA (1997) Custom and modular total knee arthroplasty. Am J Knee Surg 10(1):49–52PubMed
40.
go back to reference 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):273–277PubMedPubMedCentralCrossRef 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):273–277PubMedPubMedCentralCrossRef
41.
go back to reference 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 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
42.
go back to reference 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 6:25PubMedPubMedCentralCrossRef 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 6:25PubMedPubMedCentralCrossRef
43.
go back to reference 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):499–505PubMedCrossRef 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):499–505PubMedCrossRef
44.
go back to reference 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):2325967115590379PubMedPubMedCentralCrossRef 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):2325967115590379PubMedPubMedCentralCrossRef
45.
46.
go back to reference 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-s227PubMedCrossRef 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-s227PubMedCrossRef
47.
go back to reference 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):2015–2022PubMedCrossRef 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):2015–2022PubMedCrossRef
48.
go back to reference 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:S518CrossRef 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:S518CrossRef
51.
go back to reference 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):14–18PubMedCrossRef 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):14–18PubMedCrossRef
52.
go back to reference White PB, Ranawat AS (2016) Patient-specific total knees demonstrate a higher manipulation rate compared to “off-the-shelf implants.” J Arthroplasty 31(1):107–111PubMedCrossRef White PB, Ranawat AS (2016) Patient-specific total knees demonstrate a higher manipulation rate compared to “off-the-shelf implants.” J Arthroplasty 31(1):107–111PubMedCrossRef
53.
go back to reference 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):VIIICrossRef 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):VIIICrossRef
54.
go back to reference 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):1344–1350PubMedCrossRef 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):1344–1350PubMedCrossRef
Metadata
Title
No significant difference in early clinical outcomes of custom versus off-the-shelf total knee arthroplasty: a systematic review and meta-analysis
Authors
Jacobus H. Müller
Michael Liebensteiner
Nanne Kort
Patrick Stirling
Peter Pilot
Guillaume Demey
European Knee Associates (EKA)
Publication date
25-08-2021
Publisher
Springer Berlin Heidelberg
Published in
Knee Surgery, Sports Traumatology, Arthroscopy / Issue 4/2023
Print ISSN: 0942-2056
Electronic ISSN: 1433-7347
DOI
https://doi.org/10.1007/s00167-021-06678-6

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