The aim of this controlled multicenter study is to evaluate the clinical and radiologic outcomes of primary total knee arthroplasty (TKA) using single-use fully disposable and patient-specific cutting guides (SU) and compare the results to those obtained with traditional patient-specific cutting guides (PSI) vs conventional instrumentation (CI).
Seventy consecutive patients had their TKA performed using SU. They were compared to 140 historical patients requiring TKA that were randomized to have the procedure performed using PSI vs CI. The primary measure outcome was mechanical axis as measured on a standing long-leg radiograph using the hip-knee-ankle angle. Secondary outcome measures were Knee Society and Oxford knee scores, operative time, need for postoperative transfusion, and length of hospital stay.
The mean hip-knee-ankle value was 179.8° (standard deviation [SD] 3.1°), 179.2° (SD 2.9°), and 178.3° (SD 2.5°) in the CI, PSI and SU groups, respectively (P = .0082). Outliers were identified in 16 of 65 (24.6%), 15 of 67 (22.4%), and 14 of 70 (20.0%) knees in the CI, PSI, and SU group, respectively (P = .81). There was no significant difference in the clinical results (P = .29 and .19, respectively). Operative time, number of unit transfusion, and length of hospital stay were not significantly different between the 3 groups (P = .45, .31, and 0.98, respectively).
The use of an SU in TKA provided similar clinical and radiologic results to those obtained with traditional PSI and CI. The potential economic advantages of single-use instrumentation in primary TKA require further investigation.