No radiological and clinical advantages with patient-specific positioning guides in total knee replacement: A multicenter randomized controlled trial

BACKGROUND AND PURPOSE: Although the use of patient-specific positioning guides (PSPGs) in total knee replacement (TKR) in theory is promising, the technique has not yet proven its superior- ity compared with the conventional method. We compared radio- logical alignment and clinical outcome between TKR performed with the use of PSPGs and the conventional operation method. PATIENTS AND METHODS: 3 hospitals participated in a prospec- tive trial. 109 patients were randomized to either the conventional method or to the use of PSPGs. Postoperatively a full-length standing anteroposterior radiograph and a postoperative CT scan were taken. On the CT scan the alignments were measured for both the femoral and tibial components in the frontal, sagit- tal, and axial plane. The Knee injury and Osteoarthritis Outcome Score (KOOS), the Eurocol-5D-3L (Eq5D) descriptive system and visual analogue scale (VAS), a pain score (NRS), and range of motion (ROM) were recorded preoperatively, and at 3 months, 1, and 2 years. The operation time and length of hospital stay were recorded. RESULTS: 90 patients were available for postoperative CT mea- surements. A statistically significant difference was found between the conventional TKR instrumentation and the use of PSPGs for the frontal femoral (mean (SD) 0.6° (1.7) vs. –0.3° (2.2), CI 0.08 to 1.69) and tibial (–0.3° (1.5) vs. 0.9° (2.1), CI –1.98 to –0.44) compo- nent angles and for the tibial alignment in the sagittal plane (–3.8° (3.0) vs. –2.2° (2.5), CI –2.72; –0.42). The proportions of outliers were similar between the groups as well as the hip–knee–ankle angle, the KOOS sub scores, the Eq5D, pain (NRS), ROM, opera- tion time, and length of hospital stay. INTERPRETATION: The use of PSPGs requires a preoperative CT scan or MRI and the guides have an additional cost. As this study was not able to prove any extra benefit of the use of PSPGs we recommend the conventional operation method for TKR.