Autologous concentrated bone marrow injection for precollapse osteonecrosis of the femoral head concurrent with contralateral total hip arthroplasty: protocol for a clinical trial.

INTRODUCTION: The femoral head contralateral to the collapsed femoral head requiring total hip arthroplasty (THA) often manifests in the precollapse stage of osteonecrosis of the femoral head (ONFH). It is not yet demonstrated how autologous concentrated bone marrow injection may prevent collapse of the femoral head concurrent with contralateral THA. The primary objective is to evaluate the efficacy of autologous concentrated bone marrow injection for the contralateral, non-collapsed, femoral head in patients with bilateral ONFH, with the ipsilateral collapsed femoral head undergoing THA. METHODS AND ANALYSIS: This is a multicentre, prospective, non-randomised, historical-data controlled study. We will recruit patients with ONFH who are scheduled for THA and possess a non-collapsed contralateral femoral head. Autologous bone marrow will be collected using a point-of-care device. After concentration, the bone marrow will be injected into the non-collapsed femoral head following the completion of THA in the contralateral hip. The primary outcome is the percentage of femoral head collapse evaluated by an independent data monitoring committee using plain X-rays in two directions 2 years after autologous concentrated bone marrow injection. Postinjection safety, adverse events, pain and hip function will also be assessed. The patients will be evaluated preoperatively, and at 6 months, 1 year and 2 years postoperatively. ETHICS AND DISSEMINATION: This protocol has been approved by the Certified Committee for Regenerative Medicine of Tokyo Medical and Dental University and Japan's Ministry of Healthy, Labour and Welfare and will be performed as a class III regenerative medicine protocol, in accordance with Japan's Act on the Safety of Regenerative Medicine. The results of this study will be submitted to a peer-review journal for publication. The results of this study are expected to provide evidence to support the inclusion of autologous concentrated bone marrow injections in the non-collapsed femoral head in Japan's national insurance coverage. TRIAL REGISTRATION NUMBER: jRCTc032200229.

Recent advances in the direct anterior approach to total hip arthroplasty: a surgeon's perspective.

INTRODUCTION: The direct anterior approach (DAA) has its origins in the first and oldest approach for hip replacement in the literature, but at the same time it would not be fanciful to suggest its increasing popularity as the latest approach for hip replacement procedures, especially among younger surgeons. However, in a geographical context, the DAA is not considered the major approach in most countries. Moreover, the term DAA encompasses numerous variations in terms of technique. AREAS COVERED: In this narrative review, we describe our recent experience of advances in the DAA in terms of improved techniques and devices, along with some of its disadvantages. Also, we express our perspective on its future application. EXPERT OPINIONS: The DAA is established as one of exemplary approaches to THA. The use of fluoroscopy, the traction table, and appropriate soft tissue management has become essential in the DAA for a safe and trouble-free procedure with adequate patient comfort. With the combination of recent technologies such as robotics, three-dimensional preoperative planning, and artificial intelligence (AI)-based surgeon assist systems, we can look forward to the DAA being performed more efficiently in the future.

Validation of a preoperative formula to estimate postoperative pelvic sagittal alignment and mobility before performing total hip arthroplasty for patients with hip osteoarthritis.

BACKGROUND: Although it is important to consider pelvic alignment and mobility in the standing and sitting positions before THA, it is not known how to preoperatively predict individual postoperative pelvic alignment and mobility. The purpose of this study was to investigate the pelvic alignment and mobility before and after THA, and to develop a predictive formula using preoperative factors to calculate postoperative sagittal alignment and mobility. METHODS: One hundred seventy patients were assessed. The 170 patients were randomly divided into a prediction model analysis group (n = 85) and an external validation group (n = 85). In the prediction model analysis group, preoperative spinopelvic parameters were used to develop the predictive formulas to predict the postoperative sacral slope (SS) in standing and sitting positions and ΔSS. These were applied to the external validation group and assessed. RESULTS: R2 in multiple linear regression models for postoperative SS in standing, SS in sitting and ΔSS were 0.810, 0.672, and 0.423, respectively. The values of predicted and postoperative parameters were very close with no significant difference: SS in standing (33.87 vs. 34.23, P = 0.834), SS in sitting (18.86 vs. 19.51, P = 0.228), and ΔSS (15.38 vs. 14.72, P = 0.619). CONCLUSION: The present study showed that the pelvic alignment and mobility after THA can be predicted using preoperative factors. Although a model with higher accuracy is needed, it is important to use a predictive formula to estimate the postoperative condition before performing THA.

Highly accurate acoustical prediction using support vector machine algorithm for post-operative subsidence after cementless total hip arthroplasty.

PURPOSE: Acoustic analysis has recently been applied to cementless total hip arthroplasty (THA). The aim of this study was to develop a machine learning algorithm to predict post-operative subsidence with high accuracy. METHODS: The acoustic parameters of the hammering sounds during a broaching procedure for 62 hips in 55 patients who underwent THAs with cementless taper-wedged stem were analysed. The patient's basic background such as age, sex, height, weight and body mass index, the femoral morphological parameters and the hammering sound characteristics of 24 features of normalised sound pressure (nSP) in 24 frequency ranges were applied to binary classification using a support vector machine using the following models with different features: model A, nSP only; model B, nSP + patients' basic background features; model C, nSP + patients' basic background features + femoral morphological parameters. RESULTS: In 62 hips with 310 hammering sounds, 12 hips (19.4%) showed ≥ 3 mm of post-operative subsidence; hence, 60 hammering sounds were set as positive examples and 250 hammering sounds were set as negative examples. The AUC was very high in all models. The accuracy (AUC/sensitivity/specificity/positive predictive value/negative predictive value/accuracy rate) of each model was as follows: model A, 0.963/0.656/0.996/0.980/0.925/0.934; model B, 0.9866/0.675/1.000/1.000/0.928/0.937 and model C, 0.998/0.750/1.000/1.000/0.950/0.957. CONCLUSION: In this study, we developed a high-accuracy machine learning algorithm for post-operative subsidence using acoustic parameters and additional pre-operative features. Our results represent a step toward the realisation of acoustic monitoring to avoid the complication in cementless THA.

Acetabular morphological variation in Asian patients with femoral neck fracture: A three-dimensional CT-based study.

AIMS: The acetabular morphology varies greatly among individuals, and hypoplasia is more common in Asia than in Europe. Dislocation after bipolar hip arthroplasty (BHA) for femoral neck fracture occurs at a constant rate, and is affected by the acetabular morphology. This study aimed to clarify individual differences in the acetabula of Asian patients with displaced femoral neck fractures. PATIENTS AND METHODS: Fifty patients with displaced femoral neck fractures were assessed (50 fractured hips, 50 non-fractured hips). On CT corrected by the anterior pelvic plane, the 100 hips were assessed regarding acetabular coverage (six parameters), acetabular depth (two parameters), and acetabular opening angle (four parameters). Additional parameters related to the fracture and sex were examined. The percentile of each parameter was shown for all hips. RESULTS: There was no patient with hip dysplasia defined as superior acetabular sector angle (SASA) less than 110° Compared with men, women had a significantly smaller anterior acetabular sector angle (AASA) (p = 0.016), and significantly larger acetabular inclination angle (p = 0.006) and acetabular index angle (p = 0.034). In the group with a normal SASA, seven hips (7.3%) had an anterior wall defect (AASA<50°) and five hips (5.2%) had a posterior wall defect (posterior acetabular sector angle<90°). CONCLUSION: Older adults with femoral neck fractures can have anterior wall and posterior wall defects, even if their SASA is normal. Hidden acetabular dysplasia may be related to post-BHA dislocation. So, our results suggest that is important to accurately evaluate the acetabulum of patients with femoral neck fracture before surgery.

Grafting of autologous concentrated bone marrow processed using a point-of-care device for patients with osteonecrosis of the femoral head: A phase 1 feasibility and safety study.

Introduction: Along with the accumulating reports of autologous concentrated bone marrow (CBM) grafting for osteonecrosis of the femoral head (ONFH), the related medical device, a "point-of-care device" has also been recently developed. However, no study has confirmed the feasibility, safety, and efficiency of CBM grafting using a specific point-of-care device. Materials and methods: We designed this phase I, prospective clinical study to evaluate the feasibility and safety of autologous CBM grafting processed using a point-of-care device, the BioCUE system, in patients with ONFH. The primary outcomes were the safety and adverse event (AE), the secondary outcomes included pain score; hip function score; ONFH stage using X-ray; and the volume of the osteonecrotic area on 3T MRI. Besides, safety quality tests on the final product of concentrated bone marrow were performed. Results: Two patients (a 34-year-old man and a 33-year-old woman; three hips) with systemic lupus erythematosus were included. The incidence of AEs was 100% such as pain or transient fever after the operation, but all AEs were nonserious. No peri-operative complications were observed. Pain and hip function score remained unchanged from the preoperative to the postoperative observational periods. Safety quality test demonstrated were all negative or under the threshold. Conclusion: The feasibility and safety of grafting of concentrated autologous CBM in patients with ONFH using a point-of-care device were confirmed. A further clinical study aiming for the authorization of this procedure should be conducted in the future.

Acoustic characteristics of broaching procedure for post-operative stem subsidence in cementless total hip arthroplasty.

PURPOSE: Avoiding stem subsidence is crucial for achieving better outcome for cementless total hip arthroplasty (THA). The aim of this study was to develop a prediction model for the incidence of post-operative stem subsidence using full quantitative acoustic parameters in hammering sound during the broaching procedure and to assess the accuracy of this prediction model. METHODS: The acoustic parameters of the hammering sounds during a broaching procedure for 55 hips in 49 patients who underwent THAs with cementless taper-wedged stem were analysed. The stem subsidence was assessed at one month post-operatively, and the relationship between the acoustic parameters and the value of stem subsidence was investigated. RESULTS: The average stem subsidence was 2.15 ± 2.91 mm. The subsidence 3 mm or more was observed in eleven hips (20%), and 5 mm or more was observed in seven hips (12.7%). Basic patient's characteristics, preoperative femoral morphology and immediate post-operative canal fill ratio and stem alignment were not significantly related to the volume of stem subsidence. Nine acoustic parameters were significantly correlated with the value of subsidence. The prediction model for post-operative subsidence using only acoustic parameters during broaching procedure was established, and this model showed a positive prediction value of 100% and a negative prediction value of 90.6% for post-operative stem subsidence at 5 mm or more. CONCLUSION: Post-operative stem subsidence can be predicted by using acoustic parameters of the hammering sound during the broaching procedure. Our results suggest that we are at the start of a new era in which novel and innovative smart technologies can be used to assist in orthopaedic surgery.

Relationship between labral length and symptoms in patients with acetabular dysplasia before rotational acetabular osteotomy.

The aim of this study was to investigate the relationship between acetabular labral length and symptoms in patients with acetabular dysplasia. In a retrospective medical record review, 218 patients with acetabular dysplasia who had undergone rotational acetabular osteotomy were identified. After implementing the inclusion and exclusion criteria, 53 patients were analyzed for preoperative symptoms measured by the Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JHEQ), acetabular bone morphology parameters by anteroposterior pelvic radiographs and labral parameters by radial magnetic resonance imaging. Spearman's correlation coefficients were calculated among JHEQ scores, bone morphologic parameters and labral parameters. Multiple linear regression models to determine the predictive variables of JHEQ score and labral length were obtained. There was no correlation between bone morphologic parameters and JHEQ scores. Labral length measured anteriorly correlated with JHEQ pain {r [95% confidence interval (CI)] = -0.335 (-0.555, -0.071), P = 0.014}, movement subscale [r (95% CI) = -0.398 (-0.603, -0.143), P = 0.003], mental subscale [r (95% CI) = -0.436 (-0.632, -0.188), P = 0.001] and total JHEQ score [r (95% CI) = -0.451 (-0.642, -0.204), P = 0.001]. The multiple linear regression results showed that anterior labral length was independently associated with JHEQ subscales in some models. Meanwhile, age, acetabular head index and total JHEQ score were independently associated with anterior labral length in all models. Labral length, notably in anterosuperior area, in patients with symptomatic acetabular dysplasia was related to patient's symptom. Labral length may be an important objective image finding that can be used to assess the severity of cumulative hip instability.

Does increased diameter of metal femoral head associated with highly cross-linked polyethylene augment stress on the femoral stem and cortical hypertrophy?

PURPOSE: Cortical hypertrophy (CH) after total hip arthroplasty (THA) is thought as a process of femoral cortical functional adaptation against the stem. However, no study has been performed to investigate the association between CH and femoral head size. The purpose of this study is to investigate the factors related to femoral CH around the cementless stem after THA. METHODS: THAs in 31 patients using 36-mm metal head and as a control, age-matched 62 THAs with 32-mm metal head have been analyzed. Radiographs were reviewed at four years to determine cortical thickness change from immediate post-operative one. Pre-operative and immediate post-operative radiographs were used to calculate the femoral morphology, canal fill ratio, stem alignment, and femoral and acetabular offset. Univariate and multivariate logistic regression analyses were performed to identify the risk factors for CH. RESULTS: Patients with a 36-mm metal head had a significantly higher rate of severe CH (P = 0.001) than those with a 32-mm metal head. The multivariate logistic regression analysis with dependent variables of CH showed that the use of a 36-mm metal head had a significantly positive effect on CH. The odds ratio of a 36-mm metal head in mild CH was 2.517 (95% confidence interval, 1.032-6.143; P = 0.043), and that in severe CH was 8.273 (95% confidence interval, 2.679-25.551; P = 0.000). Age and the canal flare index were weakly and negatively influenced by mild CH. CONCLUSIONS: The use of a 36-mm metal head was the dominant risk factor for CH.