Abstract
BACKGROUND: Total knee arthroplasty using patient-specific instrumentation (TKA-PSI), which are disposable cutting block guides generated to fit each patient's 3-dimensional knee anatomy, has been developed to treat patients with end-stage osteoarthritis of the knee. Surrogate markers such as radiographic malalignment have been well investigated, however, patient-important outcomes are not well examined to elucidate the efficacy of TKA-PSI. The aim of this review is to determine if TKA-PSI improves patient-reported outcome measures (PROM), surgery time, blood loss, transfusion and complications (e.g. surgical site infection, deep venous thrombosis, and revision TKA). METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and ongoing clinical trials. For PROMs, surgery time, blood loss, and transfusion rate, we included randomized controlled trials (RCT) comparing TKA-PSI and standard TKA to treat osteoarthritis of the knee. For complications, we also included non-randomized comparative studies (non-RCT). RESULTS: This review includes 38 studies, 24 of which were RCT and 14 of which were non-RCT. These included a total of 3487 patients. The predominant population in the included studies highly reflected the general population, with 62% being female, aged over 60 and having end-stage osteoarthritis of the knee. TKA-PSI did not improve PROMs as compared to standard TKA for less than 1-year (mean difference 0.48, 95% confidence interval (CI) -1.92-0.97 in the Oxford knee score, mean 3-month follow-up) and for 1-year or more (mean difference 0.25, 95%CI - 4.39-4.89 in the WOMAC score, mean 29-month follow-up). TKA-PSI did not reduce surgery time (mean difference - 3.09 min, 95%CI -6.73-0.55). TKA-PSI decreased blood loss with a small effect size corresponding to a 0.4 g/dl hemoglobin decrease (95%CI 0.18-0.88), but did not decrease transfusion rate (risk difference - 0.04, 95%CI -0.09-0.01). TKA-PSI did not reduce complication rates (risk difference 0.00, 95%CI - 0.01-0.01 in the composite outcome). CONCLUSIONS: TKA-PSI does not improve patient-reported outcome measures, surgery time, and complication rates as compared to standard TKA. TKA-PSI decreases blood loss with a small effect, which is not enough to reduce transfusion rate.