Efficacy of Patient-Specific Instruments in Total Knee Arthroplasty: A Systematic Review and Meta-Analysis.

Background: Patient-specific instrumentation (PSI) was introduced with the aim of making the procedure of total knee arthroplasty more accurate and efficient. The purpose of this study was to compare PSI and standard instrumentation in total knee arthroplasty with regard to radiographic and clinical outcomes as well as operative time and blood loss.

Methods: A meta-analysis was conducted in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. PubMed and Embase were searched from 2011 through 2015. We included randomized controlled trials and cohort studies that reported the effect of PSI on the aforementioned outcomes. The primary end point was deviation from the mechanical axis by >3°. Random and fixed-effect models were used for analysis.

Results: A total of 44 studies, which included 2,866 knees that underwent surgery with PSI and 2,956 knees that underwent surgery with standard instrumentation, were evaluated. The risk of mechanical axis malalignment was significantly lower for PSI, with a pooled relative risk of 0.79 (p = 0.013). The risk of tibial sagittal-plane malalignment was higher for PSI than for standard instrumentation (relative risk = 1.32, p = 0.001), whereas the risk of femoral coronal-plane malalignment was significantly lower (relative risk = 0.74, p = 0.043). The risk of tibial coronal-plane malalignment was significantly higher for PSI only when employing fixed-effect meta-analysis (relative risk = 1.33, p = 0.042). Minor reductions in total operative time (-4.4 minutes, p = 0.002) and blood loss (-37.9 mL, p = 0.015) were noted for PSI.

Conclusions: PSI improves the accuracy of femoral component alignment and global mechanical alignment, but at the cost of an increased risk of outliers for the tibial component alignment. The impact of the increased probability of tibial component malalignment on implant longevity remains to be determined. Meta-analyses indicated significant differences with regard to operative time and blood loss in favor of PSI. However, these differences were minimal and, by themselves, not a substantial justification for routine use of the technology.

Level Of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.