Effectiveness of a patient-specific guide for femoral stem implantation in primary total hip arthroplasty: a randomized control trial

Abstract

The purpose of the present study was to evaluate the efficacy and feasibility of a novel CT-based patient-specific femoral alignment guide (PSG) as compared with conventional pre-operative planning during THA. From March 2020 to September 2020, patients receiving unilateral primary THA were enrolled and randomly allocated to the conventional pre-operative planning group and the PSG group. Primary outcomes were radiographic measurements including lower limb length, femoral offset, femoral anteversion and stem varus/valgus angle, and post-operative perception of leg length discrepancy (LLD). Secondary outcomes were surgical time, intra-operative blood loss, total blood loss, visual analogue scale (VAS), and Harris Hip Score (HHS). The occurrence of post-operative complications was also recorded. Of the 104 patients screened, 80 cases were enrolled for analysis. The demographics of the two groups were similar. The PSG group illustrated significant improvements (p < 0.001) in lower limb length, femoral offset, femoral anteversion, and stem varus/valgus angle. Patients in the PSG group showed more favourable HHS (p < 0.001) at sevenday, fourweek, andthreemonth (p = 0.003) follow-up. Perception of LLD was found significantly lower in the PSG group at three tmonth (p = 0.043), sixmonth (p = 0.025), and 12-month (p = 0.048) follow-up. Utilization of the PSG had no significant increase in operative time, intra-operative blood loss, total blood loss, or VAS. No complication was noted in either group. Relative to conventional pre-operative planning, the application with the PSG could potentially provide a simple and reliable solution for improving femoral prosthesis orientation in THA with high accessibility and low healthcare costs. TRN: ChiCTR2000031043 Date of registration: 2020/3/21.