Patient-specific instrumentation does not shorten surgical time: a prospective, randomized trial.

The primary purpose of this prospective, randomized study was to determine if patient-specific instrumentation (PSI) for total knee arthroplasty (TKA) shortened surgical time. Secondarily the number of instrument trays and alignment were also compared to cases performed with traditional instrumentation (TI). Fifty-two cases (26 per group) were randomized and videotaped to measure the length of surgery, as well as each individual surgical step. Component alignment and mechanical axis was measured radiographically for each patient. Total surgical time was over 4 minutes shorter for patients in the TI group (57.4 minutes vs. 61.8 minutes; P<0.01). More instrument trays were used in the TI group (7.3 vs. 2.5; P<0.001). There was no significant difference in mechanical alignment between groups on postoperative long alignment radiographs (P=0.77). In conclusion, PSI did not shorten surgical time or improve alignment compared with TI in this prospective, randomized trial, but did reduce the required number of trays.