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

Abstract

Purpose The purpose of this systematic review and meta-analysis was to collect, synthesise and critically appraise indings of clinical studies that report outcomes of custom total knee arthroplasty (TKA). The hypothesis was that, compared to ofthe-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 efect in favour of OTS TKA (odds ratio (OR), 0.4; p = n.s.) but the result did not reach statistical signiicance. Four studies found no statistically signiicant diference in KSS knee (standardised mean diference (SMD), − 0.10; p = n.s.) and function (SMD, 0.03; p = n.s.), and ive studies found no statistically signiicant diference in range of motion (SMD, 0.02; p = n.s.). One study that compared bone-implant it 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 signiicant beneits compared to OTS TKA in terms of pooled clinical outcomes, but had considerably higher early revision rates. The indings 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. KeywordsArthroplasty • Replacement • Knee • Total knee arthroplasty • TKA • Custom • Patient-speciic European Knee Associates (EKA) members are listed in the Acknowledgement section.

No difference in patient-reported satisfaction after 12 months between customised individually made and off-the-shelf total knee arthroplasty

“…A large retrospective study recently found a high satisfaction rate (89%, mean follow-up 2.8 years) and high implant survivorship (98.5%) [ 37 ]. However, based on the current evidence, CIM TKA are not clearly superior [ 24 , 25 , 51 ] and long-term results are not yet available. A recent systematic review revealed the lack of strong methodological studies [ 51 ].…”

“…First results are promising in terms of bone preservation [ 45 ], ligament balancing [ 45 ], alignment [ 2 , 54 ] and patient satisfaction [ 32 , 37 ]. However, sufficient data are still lacking: comparative studies are sparse and randomised controlled trials on this topic are absent [ 25 , 51 ]. A prospective study comparing PROMs of patients with CIM and OTS TKA has not yet been published.…”

Patient Specific Instruments and Patient Individual Implants—A Narrative Review

“…On the other hand, neither Moret et al [ 31 ], in a recent literature review, nor Müller et al [ 32 ], in the most recent meta-analysis on total knee arthroplasty (TKA), could find a difference for the clinical outcome between conventional implants and CMI.…”

Custom total knee arthroplasty combined with personalised alignment grants 94% patient satisfaction at minimum follow-up of 2 years

“…A recent systematic review and meta-analysis comparing custom versus OTS TKA revealed no significant differences in early clinical outcomes [34]; however, all studies that reported functional outcomes investigated the ConforMIS TKA system, which customises the tibiofemoral compartments and uses mechanical alignment, without customising the patellofemoral compartment or personalising alignment. A recent study reported the radiographic outcomes of a CT-based custom TKA system that customises all three knee compartments as well as a 'personalised alignment' strategy [5], after which two other studies reported early clinical outcomes of the same system at a minimum follow-up of 1 year [33,39].…”