Preliminary experiments
The natural frequencies (<10 kHz) of surgical instruments used in THA surgery, including a hip prosthesis (Accolade II, Stryker, Tokyo, Japan), surgical hammer (stainless hammer 01-412-01 Large, Mizuho, Tokyo, Japan), and modular handle and stem impactor (1020-2900, 1020-1870, Stryker, Tokyo, Japan), were analyzed in an anechoic room using a previously described method 10.
Patients
All procedures performed in this study involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study protocol was approved by the Ethics Committee of Juntendo University Hospital, Tokyo, Japan. Informed consent was obtained in a manner approved by the Ethics Committee from all individual participants included in this study. From November 2018 to October 2020, 62 patients (65 hips) undergone Primary THA who agreed to participate to this study were initially included (Fig. 1). Exclusion criteria were (i) patients who underwent THA for osteonecrosis, femoral neck fracture, or rheumatoid arthritis (ii) the surgery used a prosthesis other than the Accolade II stem, (iii) the surgery was performed by a junior surgeon, and (iv) patients had stem subsidence (>2 mm) at 1 month post-operation. After reviewing the inclusion and exclusion criteria, 17 women and 3 men were included, with an average age of 66.4±8.23 years and an average body mass index of 23.76±2.77 kg/m2. One patients had simultaneous bilateral THA. To investigate the sound frequency changes among femoral morphologies, these patients were divided into the Dorr A and Dorr B groups (no patient had a Dorr C-type femur) based on Dorr classification 12.
Surgical procedure
The surgeries were performed by four experienced orthopedic surgeons via the direct anterior approach with a cementless proximal hydroxyapatite-coated stem (Accolade II, Stryker, Tokyo, Japan) using the distal part of the Smith-Petersen approach with the patient in the supine position on a surgical traction table as previously described 13. The following is the brief description of this surgical procedure 13. The fascia of the tensor fascia lata muscle was incised at approximately 2 cm lateral to the skin incision to prevent lateral femoral cutaneous nerve injury. The intermuscular space between the tensor fascia lata and sartorius muscles was then bluntly entered. The anterior articular capsule was exposed and incised. Intraoperative X-ray photography was used to confirm that the broach was appropriately aligned, and the porous part of the broach contacted the cortical bone. The stem size was determined using the same size of the last trial insertion of the broach. All patients underwent standardized postoperative rehabilitation with full weight bearing 1-day post-surgery.
Sound data collection during the THA
A highly sensitive sound level meter (LA-7500, Onosokki, Kanagawa, Japan) was used to record the hammering sound of the stem insertion. In all cases, the sound level meter was set on a tripod mount at 1 m high and 2 m away from the surgical table in the same operating room (Fig. 2). Recordings were made in the range of 40–110 dB using Z frequency weighting (flat-weighted filter) and fast time weighting at a sampling rate of 64 kHz and a 16-bit sampling depth.
Sound data analysis
Oscope ver 2.1, (Onosokki, Kanagawa, Japan) was used for the sound analysis. Recorded sound data were analyzed using a rectangular weighted window and 50% overlap at a maximum range of 12.5 kHz via fast fourier transform (FFT) analysis (Fig. 3). The first three and last one hammering sounds during the stem insertion were excluded from the analysis to avoid potential hammering inconsistencies, The fourth to sixth hammering sounds were defined as early-stage insertion hammering sounds. The second to fourth hammering sounds from the end were defined as late-stage insertion hammering sounds. If noises were mixed in with these hammering sounds, or an improper hammering was detected on the spectrogram, those hammering sound would be switched to the previous or next one.
The following analysis compared the early- and late-stage insertion hammering sounds. The overall spectrum frequency of the recorded sound was divided into 25 frequency bands in the range of 0.5 kHz from 0–12.5 kHz. Because frequency bands below 0.5 kHz were mixed with noises ranging from 0.08–0.26 kHz, such as voiced speech from a typical adult, 0–0.5 kHz was thought to inaccurately reflect sound changes during the stem insertion. Moreover, previous studies detected no changes below 0.5 kHz 10,11,14. Therefore, the 0–0.5 kHz frequency band was excluded from the comparison. Sound changes between the early and late stages were compared first by using the absolute sound pressure (Pa) and then by using the normalized sound pressure in each frequency band. Because the average overall absolute sound pressure (Pa) differed between the early and late stages, the analysis using the normalized sound pressure was used. Normalized sound pressure was calculated as the ratio of the absolute sound pressure (Pa) of each frequency band to the average overall frequency spectrum (0.5–12.5kHz). Next, correlations were determined between the femoral morphology, canal fill ratio and absolute sound pressure (Pa), followed by normalized sound pressure in the late stage. Finally, sound changes between Dorr A and B were determined for the late stage.
Assessment ofthefemoral morphology and canal fill ratio of the stem.
Radiographs of the femoral morphology and canal fill ratio were assessed using the final preoperative and immediate postoperative Anterior Posterior hip radiographs. Preoperative radiographs were used to analyze five morphologic parameters as follows.
(i) Canal-calcar ratio (CCR): ratio of the intracortical diameter of the femoral canal isthmus at 10 cm below the lesser trochanter to the intracortical diameter of the proximal femur at the medial tip of the lesser trochanter 15.
(ii) Canal-flare index (CFI): ratio of the intracortical diameter of the proximal femoral isthmus at 2 cm above the lesser trochanter to the intracortical diameter of the femoral canal isthmus at 10 cm below the lesser trochanter 16.
(iii) Morphologic cortical index (MCI): ratio of the extracortical diameter of the femur at the medial tip of the lesser trochanter to the intracortical femoral diameter at 7 cm below the lesser trochanter 15,17.
(iv) Canal-bone ratio (CBR): ratio of the intracortical and extracortical diameters of the femoral canal isthmus at 10 cm below the lesser trochanter 18.
Postoperative radiography was used to assess the canal fill ratio (CFR) of the stem, defined as the stem width divided by the canal width at four points at the lesser trochanter, 2 cm above, 2 cm below, and 7 cm below the lesser trochanter. The proximal-distal matching ratio of the CFR at 2 cm above and 7 cm below the lesser trochanter was also considered 19.
A single observer (S.I.) who was not involved in the sound analysis analyzed the measurements. Radiographs were assessed using the ruler function of the Picture Archiving and Communication System at our institution (Fujifilm Synapse 3.2.1 SR-356; Fujifilm Corp, Tokyo, Japan).
Statistical analysis
Statistical analysis was performed using SPSS software, ver 26.0 (IBM, Armonk, NY, USA). Patient demographics are expressed as the mean ± standard deviation. Two-tailed paired t-tests and Wilcoxon signed-rank tests were used to compare paired data. Spearman rank correlation was used to evaluate relationships between variables. Differences and correlations were considered statistically significant if p < 0.05.