The efficacy and safety of patient-specific instrumentation in primary total knee replacement: a systematic review and meta-analysis.

Introduction: Patient-specific instrumentation (PSI) for primary total knee arthroplasty (TKA) surgery has been shown to increase accuracy of component positioning. However, it is unclear whether this also translates to actual benefits for patients in terms of better outcomes (efficacy) or less complications such as revisions (safety). We therefore systematically reviewed the literature to determine the efficacy and safety of PSI in primary TKA.

Methods: Randomized controlled trials comparing PSI to non-PSI in primary TKA were included. A random effects model was used with meta-regression in case of heterogeneity.

Results: Forty-three studies were included with a total of 1816 TKA in the PSI group and 1887 TKA in the control group. There were no clinically relevant differences between the PSI-group and non-PSI group regarding all outcomes. There was considerable heterogeneity: meta-regression analyses showed that the year the study was published was an important effect modifier. Early publications tended to show a positive effect for PSI compared to non-PSI TKA, whereas later studies found the opposite.

Conclusion: Based on evidence of moderate certainty, our study suggested that there were no clinically relevant differences in efficacy and safety between patients treated with PSI TKA and patients treated with non-PSI TKA.