Patient-Specific Instrumentation Does Not Shorten Surgical Time: A Prospective, Randomized Trial

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Abstract

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.

Section snippets

Methods

This level 1 prospective, randomized study compared PSI with TI. Each surgery was videotaped and the timing of each operative step as well as the overall operative time was recorded. Inclusion criteria for this study were patients with non-inflammatory osteoarthritis scheduled for unilateral TKA. Exclusion criteria included previous ipsilateral hip, knee, or ankle replacement, a body mass index greater than 41 kg/m2, or a flexion contracture greater than 20 degrees.

A power analysis was performed

Results

Of the 78 patients initially enrolled in the study, 26 were excluded from the study after randomization. Twelve patients canceled surgery (six in the traditional group and six in the PSI group) for personal or family reasons. Nine of the PSI patients were unable to get a CT scan of their leg, for reasons related to cost (4), non-compliance (4), and hardware (1). Five others withdrew for various reasons including one who expired. Ultimately 52 patients had TKA surgery, 26 with traditional

Discussion

To address the growing volume of patients that will require total knee arthroplasty in the coming years [1], manufacturers have developed patient specific instruments to simplify the process on the day of surgery. Some have argued that these instruments may reproduce the alignment seen with computer assisted surgery 3., 7., 8., 9., 10., 11. without the upfront cost of the computer or the intraoperative hassle of placing pins and utilizing a camera and tracking device. Surgeons and manufacturers

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The Conflict of Interest statement associated with this article can be found at http://dx.doi.org/10.1016/j.arth.2013.04.049.

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