Small improvements in mechanical axis alignment achieved with MRI versus CT-based patient-specific instruments in TKA: a randomized clinical trial.

backgroundPatient-specific instrumentation in TKA has the proposed benefits of improving coronal and sagittal alignment and rotation of the components. In contrast, the literature is inconsistent if the use of patient-specific instrumentation improves alignment in comparison to conventional instrumentation. Depending on the manufacturer, patient-specific instrumentation is based on either MRI or CT scans. However, it is unknown whether one patient-specific instrumentation approach is more accurate than the other and if there is a potential benefit in terms of reduction of duration of surgery. QUESTIONS/PURPOSES: We compared the accuracy of MRI- and CT-based patient-specific instrumentation with conventional instrumentation and with each other in TKAs. The three approaches also were compared with respect to validated outcomes scores and duration of surgery.

methodsA randomized clinical trial was conducted in which 90 patients were enrolled and divided into three groups: CT-based, MRI-based patient-specific instrumentation, and conventional instrumentation. The groups were not different regarding age, male/female sex distribution, and BMI. In all groups, coronal and sagittal alignments were measured on postoperative standing long-leg and lateral radiographs. Component rotation was measured on CT scans. Clinical outcomes (Knee Society and WOMAC scores) were evaluated preoperatively and at a mean of 3 months postoperatively and the duration of surgery was analyzed for each patient. MRI- and CT-based patient-specific instrumentation groups were first compared with conventional instrumentation, the patient-specific instrumentation groups were compared with each other, and all three approaches were compared for clinical outcome measures and duration of surgery.

resultsCompared with conventional instrumentation MRI- and CT-based patient-specific instrumentation showed higher accuracy regarding the coronal limb axis (MRI versus conventional, 1.0° [range, 0°-4°] versus 4.5° [range, 0°-8°], p < 0.001; CT versus conventional, 3.0° [range, 0°-5°] versus 4.5° [range, 0°-8°], p = 0.02), femoral rotation (MRI versus conventional, 1.0° [range, 0°-2°] versus 4.0° [range, 1°-7°], p < 0.001; CT versus conventional, 1.0° [range, 0°-2°] versus 4.0° [range, 1°-7°], p < 0.001), and tibial slope (MRI versus conventional, 1.0° [range, 0°-2°] versus 3.5° [range, 1°-7°], p < 0.001; CT versus conventional, 1.0° [range, 0°-2°] versus 3.5° [range, 1°-7°], p < 0.001), but the differences were small. Furthermore, MRI-based patient-specific instrumentation showed a smaller deviation in the postoperative coronal mechanical limb axis compared with CT-based patient-specific instrumentation (MRI versus CT, 1.0° [range, 0°-4°] versus 3.0° [range, 0°-5°], p = 0.03), while there was no difference in femoral rotation or tibial slope. Although there was a significant reduction of the duration of surgery in both patient-specific instrumentation groups in comparison to conventional instrumentation (MRI versus conventional, 58 minutes [range, 53-67 minutes] versus 76 minutes [range, 57-83 minutes], p < 0.001; CT versus conventional, 63 minutes [range, 59-69 minutes] versus 76 minutes [range, 57-83 minutes], p < .001), there were no differences in the postoperative Knee Society pain and function and WOMAC scores among the groups.

conclusionsAlthough this study supports that patient-specific instrumentation increased accuracy compared with conventional instrumentation and that MRI-based patient-specific instrumentation is more accurate compared with CT-based patient-specific instrumentation regarding coronal mechanical limb axis, differences are only subtle and of questionable clinical relevance. Because there are no differences in the long-term clinical outcome or survivorship yet available, the widespread use of this technique cannot be recommended.