Cost-Effective 3-Dimensionally Printed Patient-Specific Glenoid Drill Guides Versus Standard Non-Specific Instrumentation: A Randomized Controlled Trial Comparing the Accuracy of Glenoid Component Placement in Anatomic Total Shoulder Arthroplasty.

BACKGROUND:Traditional, commercially-sourced patient-specific instrumentation (PSI) systems for shoulder arthroplasty improve glenoid component placement but can involve considerable cost and outsourcing delays. The purpose of this randomized controlled trial was to compare the accuracy of glenoid component positioning in anatomic total shoulder arthroplasty (aTSA) using an in-house, point-of-care, 3-dimensionally (3D) printed patient-specific glenoid drill guide versus standard non-specific instrumentation. METHODS:This single-center randomized controlled trial included 36 adult patients undergoing primary aTSA. Patients were blinded and randomized 1:1 to either the PSI or the standard aTSA guide groups. The primary endpoint was accuracy of glenoid component placement (version and inclination), which was determined using a metal-suppression CT scan taken between 6 weeks to 1 year postoperatively. Deviation from the preoperative 3D templating plan was calculated for each patient. Blinded postoperative CT measurements were performed by a fellowship-trained shoulder surgeon and a musculoskeletal radiologist. RESULTS:Nineteen patients were randomized to the patient-specific glenoid drill guide group, and 17 were allocated to the standard instrumentation control group. There were no significant differences between the two groups for native version (p = 0.527) or inclination (p = 0.415). The version correction was similar between the two groups (p = 0.551), and the PSI group was significantly more accurate when correcting version than the control group (p = 0.042). The PSI group required a significantly greater inclination correction than the control group (p = 0.002); however, the two groups still had similar accuracy when correcting inclination (p = 0.851). For the PSI group, there was no correlation between accuracy of component placement and native version, native inclination, or Walch classification of glenoid wear (p > 0.05). For the control group, accuracy when correcting version was inversely correlated with native version (p = 0.033), but accuracy was not correlated with native inclination or Walch classification of glenoid wear (p > 0.05). The intraclass correlation coefficient (ICC) was 0.703 and 0.848 when measuring version and inclination accuracy respectively. CONCLUSION:When compared to standard instrumentation, the use of in-house, 3D-printed, patient-specific glenoid drill guides during aTSA led to more accurate glenoid component version correction and similarly accurate inclination correction. Additional research should examine the influence of proper component position and use of patient-specific instrumentation on clinical outcomes.