The current study investigated the accuracy in achieving proper lower limb alignment and individual component positions after total knee arthroplasty (TKA) with 3 different instrumentation techniques. It was hypothesized that patient-specific instruments (PSI) would achieve more accurate lower limb alignment and component positions compared to conventional instruments (CON).
Ninety knees in 81 patients were randomized in 1:1:1 ratio into CON, computer navigation (NAV) and PSI groups to receive TKA. The surgical routines were standardized. The lower limb mechanical axis and individual component positions were assessed on standard radiographs. Tourniquet time, operation time and patients’ functional scores were documented.
Conventional instruments and PSI were more likely to result in an excessively flexed femoral component (p = 0.001) compared to NAV. Number of outliers in postoperative lower limb alignment, and other components positions in the coronal and sagittal plane showed no statistically significant difference. The mean tourniquet time and operation time was significantly shorter in CON and PSI groups than NAV group (p < 0.001). Four early complications occurred in the PSI group (p = 0.015). At 3-month follow-up, there was no difference in terms of the knee range of motion and patients’ function among the 3 groups.
No significant radiological and clinical benefit could be demonstrated in using PSI over CON or NAV in TKA. Routine use of PSI is not recommended because of the extra cost and waiting time.
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Appendix: The inclusion and exclusion criteria
Appendix: The inclusion and exclusion criteria
The inclusion criteria included patients who were indicated for primary TKA, physically and mentally willing and able to comply with the postoperative scheduled clinical and radiographic evaluations, and agreed to sign an informed consent document specific to the study.
The exclusion criteria included patients who were not suitable for MRI or whose MRI failed to satisfy the manufacturer’s protocol; patients who had previous knee operations, extra-articular deformity in tibia or femur, associated medical diseases that could affect rehabilitation, active systemic infection or infection near the knee joint, current medical conditions that made them unfit for surgery or any conditions which in the opinion of the investigator suggested that the patient would not be compliant with the study protocol.
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Yan, C.H., Chiu, K.Y., Ng, F.Y. et al. Comparison between patient-specific instruments and conventional instruments and computer navigation in total knee arthroplasty: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc 23, 3637–3645 (2015). https://doi.org/10.1007/s00167-014-3264-2