From April 2020 to July 2021, 68 consecutive hips in 66 patients underwent primary cementless THA using the Naviswiss in the lateral decubitus position (the navigation group). There were 55 women and 11 men, with a mean age of 72 years (range, 61–91 years) and a mean body mass index (BMI) of 25 kg/m2 (range, 18–33 kg/m2). The preoperative diagnoses were osteoarthritis (OA) in 61 hips (Crowe group 1, 55 hips; group 2, 1 hip; group 3, 2 hips; group 4; 3 hips), osteonecrosis of the femoral head (ONFH) in 4 hips, rapidly destructive coxarthrosis (RDC) in 2 hips, and rheumatoid arthritis (RA) in 1 hip. The surgical approaches were the posterior approach in 23 hips and the superior approach in 45 hips. The criterion for the superior approach was slight to moderate deformity of the acetabulum or femoral head because this approach was more minimally invasive than the posterior approach. We referred to the report in which Murphy described the surgical technique of the superior approach [6]. In this study, an 8- to 10-cm incision was made starting at the tip of the greater trochanter and extending proximally, in line with the femoral shaft axis. The gluteus maximus fibers were spread, and the gluteus medius was mobilized anteriorly. The piriformis tendon was mobilized posteriorly, the gluteus minimus muscle was mobilized anteriorly, and the superior capsule was exposed. A vertical capsulotomy was performed from the trochanteric fossa to the acetabular rim. The anterior capsule and the posterior capsule were retracted, and the entire acetabulum was exposed. The subsequent procedures for excision of the labrum, reaming of the acetabulum, insertion of the cup, and repair of the capsule were similar to the posterior approach. All patients in the navigation group had a SQRUM TT SHELL (Kyocera, Osaka, Japan). As a control group, 68 retrospective consecutive hips in 56 patients who underwent THAs with manual implant techniques in the lateral decubitus position between February 2012 and April 2017 were included. There were 51 women and 5 men with a mean age of 62 years (range, 34–86 years) and a mean BMI of 24 kg/m2 (range, 15–37 kg/m2). The preoperative diagnoses were OA in 63 hips (Crowe group 1, 51 hips; group 2, 8 hips; group 3, 3 hips; group 4; 1 hip) and ONFH in 5 hips. The surgical approach was the posterior approach in all cases. A Regenerex Ringloc Acetabular Component was used in 37 hips, a Continuum Acetabular Shell was used in 22 hips, a G7 PPS Finned BoneMaster Acetabular Shell was used in 8 hips, and Trilogy Acetabular Shell was used in 1 hip (all components from Zimmer Inc, Warsaw, IN). This cohort was a part of the control group of our previous report [7]. The patients’ demographic characteristics are shown in Table 1.
Table 1
Patients’ demographic characteristics
| Navigation group | Control group | p-value |
Gender (Women/Men) | 55/11 | 51/5 | ns |
Age (years) | 72 (61–91) | 62 (34–86) | < 0.001 |
Body mass index (kg/m2) | 25 (18–33) | 24 (15–37) | ns |
Diagnosis | | | |
Osteoarthritis | 61 | 63 | ns |
Crowe group 1 | 55 | 51 |
Crowe group 2 | 1 | 8 |
Crowe group 3 | 2 | 3 |
Crowe group 4 | 3 | 1 |
Osteonecrosis of the femoral head | 4 | 5 |
Rapidly destructive coxarthrosis | 2 | 0 |
Rheumatoid arthritis | 1 | 0 |
Surgical approach | | | |
Posterior approach | 23 | 68 | < 0.001 |
Superior approach | 45 | 0 |
The Naviswiss consists of a handheld navigation device and miniature precision tracking tags. Intraoperatively, all patients were placed in the lateral decubitus position and fixed with the conventional lateral fixation device, and two fixation pins, 3.0 mm in diameter, were placed on the iliac crest to fix the tag. The other tag was attached to the pelvic caliper. A point on the chest that lies on the patient’s mid chest axis, and the greater trochanter were identified. Both points were palpated with the pelvic caliper and the body axis was registered (Fig. 1a). During cup impaction, this tag was attached to the cup impactor, and cup inclination and anteversion were measured (Fig. 1b). Angles displayed on the screen were the radiographically defined angles (Fig. 1c). The cup orientation was planned to be 40° in radiographic inclination and 15° in radiographic anteversion relative to the functional pelvic plane (FPP) based on the definitions of Murray [8]. In the control group, because cup placement was performed using a mechanical alignment guide, the target angle of cup operative inclination was 40° and of anteversion was 20° (radiographic inclination of 42° and radiographic anteversion of 15°).
Postoperative cup position was assessed using a 3D-Template system after CT examination (ZedHip, Lexi, Tokyo, Japan). Cup radiographic inclination and anteversion were evaluated relative to the FPP. The absolute values of errors of radiographic inclination and anteversion were calculated by subtracting postoperative angles from the target angles. The proportions of hips within Lewinnek’s safe zone (40° ± 10° inclination; 15° ± 10° anteversion) were analyzed [9]. To assess the accuracy of the navigation system, absolute differences between the intraoperative values measured by the navigation device and the postoperative values measured by postoperative CT were calculated. Intraoperative loosening of the fixation pins and complications such as pin-site infection, nerve injury, and dislocation were examined.
On the basis of previous data, the difference (mean ± standard deviation) between the image-free navigation and conventional groups of cup anteversion was 7.0 ± 8.7° [10]. The power calculation indicated that 25 cases would be necessary for the study relative to historical controls (α = 0.05, power = 0.8). The intraclass correlation coefficient (ICC) was used to analyze intra-observer and inter-observer reliabilities. All statistical analyses were performed using SPSS version 27 software (SPSS Inc., Chicago, IL). Patients’ demographic characteristics including age and BMI were compared between the two groups using the Mann–Whitney U test. The Chi-squared test and Fisher’s exact test were used to compare sex, diagnosis, and surgical approach. The Mann–Whitney U test was used to compare the absolute values of errors from target angles. The Chi-squared test and Fisher’s exact test were used to compare the percentage of hips within the safe zone and the incidence of complications. Spearman’s rank correlation coefficients were used for correlation analysis of absolute values of navigation error with age and BMI. The Mann-Whitney U test was used to compare navigation error between women and men, OA and the others, Crowe group 1 and Crowe group 2 to 4 [11], and posterior approach and superior approach.
This study was approved by the institutional review board of our hospital, and informed consent was obtained from each patient. All methods were performed in accordance with the Declaration of Helsinki.