A PROSPECTIVE RANDOMISED COMPARISON OF PATIENT SPECIFIC INSTRUMENTS WITH STANDARD TKA INSTRUMENTATION

Summary Statement A prospective randomised evaluation of primary TKA utilizing patient specific instruments demonstrated great accuracy of bone resection, improved sagittal alignment and the potential to improve functional outcomes and reduce operating room costs when compared to standard TKA instrumentation. Introduction Patient specific instruments (PSI), an alternative to standard total knee arthroplasty (TKA) technology, have been proposed to improve the accuracy of TKA implant placement and post-operative limb alignment. Previous studies have shown mixed results regarding the effectiveness of PSI. The purposes of this study were (1) to evaluate the accuracy of the pre-operative predicted PSI plan compared to intra-operative TKA resection measurements, (2) to compare patient-reported outcome measures of PSI and standard TKA patients, and (3) to compare the incremental cost savings with PSI. Patients and Methods This randomised, prospective pilot study of 19 patients undergoing primary TKA with a cruciate-retaining cemented prosthesis (NexGen, Zimmer Inc.) was conducted by a single high-volume arthroplasty surgeon (DCA). Patients were randomised to PSI or standard instrumentation. Patients randomised to the PSI cohort received a pre-operative knee MRI for PSI fabrication using Zimmer proprietary software. 10 standard TKA and 9 PSI TKA were completed. Pre-operative baseline SF-36 and WOMAC scores were collected. Operative data collected included operating room times, implant details, femoral (medial/lateral distal and posterior) and tibial (medial/lateral) cut thicknesses, and number of instrument trays used. Hospitalization data collected included length of stay, blood loss, drain output, and transfusion requirements. Follow-up occurred at 2 weeks, 6–8 weeks, 3 months, 6 months, and 1 year, with SF-36 and WOMAC scores collected at each time point. Routine radiographic analysis was carried out in both cohorts. Extensive financial data was collected including costs of operating room use and anesthesia, implants, and hospitalization. Statistical analyses included t-tests for continuous variables and chi-square tests for categorical variables. Results All femoral and tibial implant sizes used during TKA matched the component sizes predicted by the PSI software. Flexion gap bone resection (posterior medial/lateral femoral cuts) was extremely accurate ( p ). No significant differences in coronal mechanical limb alignment existed between the two cohorts ( p>0.05 ). There were no differences in operating room times, length of stay, or transfusions between the two groups. PSI patients used 4 fewer instrument trays per case ( p ). There were no significant differences in functional outcome scores between the two groups ( p >0.05). Discussion/Conclusion PSI TKA demonstrated outstanding accuracy in bone resection when compared with the custom operative plan. There was no difference in post-operative coronal limb alignment or individual component alignment between the two groups, but an improvement in tibial component alignment in the sagittal plane in the PSI cohort was statistically significant. The number of instrument trays in PSI TKA9s were significantly less than standard TKA which led to less cost for instrument sterilization and assembly, and quicker room set-up. PSI instrumentation resulted in accurate bone resection and appropriate limb and component alignment after primary TKA in this prospective randomised evaluation.