Research object
This study retrospectively analyzed the non-traumatic, non-surgical ONFH patients admitted to the First Affiliated Hospital of Guangzhou University of Chinese Medicine from January 2010 to December 2016. The inclusion criteria were defined as (i) patients with complete imaging data and without collapse of the femoral head at the first visit, (ii) aged 19 to 60 years old, (iii) who reported no hip trauma and history of surgery. The exclusion criteria were as follows: the imaging data were incomplete during the follow-up, or available imaging data with poor quality (such as pelvic tilt). Patients with cardio-cerebral vascular diseases, nervous system diseases, severe illness, or rheumatoid arthritis were also excluded. This study had been approved by the ethical review board of The First Affiliated Hospital of Guangzhou University of Chinese Medicine (No: Y[2019]118).
Conservative Treatment
All patients always accepted oral administrations with TCM Yuanshi Shengmai Chenggu tablet (6 tablets each time, 3 times per day, institutional approval number: Z20070828) and Fufang Shengmai Chenggu capsule (4 capsules each time, 3 times per day, institutional approval number: Z20071224). The two drugs were prepared by the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine (Guangzhou, China). Along with the oral administration, muscle group exercises with emphasis on anterior flexor muscles, abductor muscles and adductor muscles and protective weight-bearing exercises were performed.
Imaging evaluation of necrotic collapse
Necrotic collapse was evaluated by comparing patients’ X-ray radiographs simultaneously with the standard photographic grading of the hip joint in the quantitative collapse standard proposed by the Association Research Circulation Osseous (ARCO) in 1993 [13]. The 4 grades for necrotic collapse were defined as: grade α, no collapse; grade β, collapse of the femoral head of less than 2 mm or 15%; grade γ, collapse of less than 4 mm or 30%; and grade δ, collapse of less than 4 mm or greater than 30%.
Definition of the medial space ratio
According to the standard hip joint X-ray radiographs, a vertical tangent line “a” was drawn from the medial edge of the femoral head, and a vertical line “b” was drawn at the lowest point of the ipsilateral acetabular teardrop. The distance “c” between the two lines a and b was the medial space of the hip joint. Subsequently, a vertical line “d” at the outermost margin of the ipsilateral acetabulum was drawn, parallel to line a and line b. The distance from line b to line d was distance “e”, and the e/c ratio was defined as the medial space ratio (Fig. 1).
Grouping according to the first-visit medial space ratio
The medial space ratio was classified and assigned based on the data at the first visit (Table 1). Because the size of the medial space at the initial diagnosis was smaller than that at the end point in group A (n = 0), B (n = 3), and F (n = 0), the indice was excluded. This analysis mainly used data from the first-visit medial space ratio in group C (n = 36), D (n = 71), and E (n = 32) as variables.
Table 1
Grouping according to the first-visit medial space ratio
Grouping | F | E | D | C | B | A |
First visit medial space ratio | 2 < = F < 3 | 3 < = E < 4 | 4 < = D < 5 | 5 < = C < 6 | 6 < = B < 7 | 7 < = A < 8 |
Statistical methods
The Kaplan-Meier survival analysis of the first-visit medial space ratio was performed with grade γ collapse of the femoral head as the endpoint event. The above data were imported into SPSS version 22.0 statistical analysis software, and a P value of < 0.05 was considered statistically significant.
Finite element experiments
Establishment of 3D models of the total hip joint
A 30-year-old healthy woman was excluded from our analysis due to the history of hip and systemic diseases. DICOM data obtained from computerized tomography(CT)scans were imported into the Mimics 16.0 system (Fig. 2A,B). After threshold segmentation, approximate contours of the cortical bone in the femur and patella were obtained, and then repaired by region growth, skin editing, and cavity filling. After the surface was smoothed, Those models were exported as a stl file format and imported into the Geomagic-Studio 11 system to mesh and fit the surface to obtain a stp-format cortical bone model. The above steps were repeated to obtain a cancellous bone model, and then it was imported in the Solidworks 2014 software for a 3D model of the femoral and patella bone structures. Subsequently, the thickness and contour of the cartilage in the bony 3D model were defined based on MRI images after registration and fusion using the Solidworks 2014 software system, and a 3D surface was constructed based on the contour curve. Finally, independent 3D models of femoral head cartilage and acetabular cartilage were reconstructed (Fig. 2C,D,E).
Establishment of necrotic zone models
The JIC type C1 ONFH was used as a model reference to establish a necrotic zone model. A circle α was drew around the center of the femoral head using the Solidworks software (Fig. 3A). Then the circle α was stretched and the femoral head was cut. Finally, the JIC type C1 ONFH model including the necrotic area was established (Fig. 3B).
Establishment of multiple hip joint models based on graded medial space ratios
Based on data from clinical research, the medial space ratio and CE angle were calculated. The hip joint models were divided into 7 groups with a reduction of every 0.3 in the medial space ratio. The origin control was defined as the starting coordinate point in Solidworks software environment and the lateral direction of the hip joint as the positive direction of the X axis to move the model of the femur and other components to the outside. Seven models α, β, γ, δ, ε, ζ, and η (Fig. 4) were established according to the medial space ratios (Table 2). Furthermore,, 14 models were constructed based on the presence or absence of necrotic areas in the 7 models: non-necrotic model α, β, γ, δ, ε, ζ, and η, and necrotic model α, β, γ, δ, ε, ζ, and η.
Establishment of different medial space hip joint models
Table 2
Setting of the medial space ratio of each model
| medial space | medial space ratio | CE angle | Distance from teardrop to outer edge of acetabulum |
α model | 1.11 cm | 4.74 | 39.2 | 5.23 |
β model | 1.17 cm | 4.44 | 35.1 | 5.23 |
γ model | 1.26 cm | 4.14 | 31.4 | 5.23 |
δ model | 1.36 cm | 3.84 | 28.2 | 5.23 |
ε model | 1.47 cm | 3.54 | 25.4 | 5.23 |
ζ model | 1.61 cm | 3.24 | 22.5 | 5.23 |
η model | 1.77 cm | 2.94 | 20.0 | 5.23 |
Analysis of settings of the finite element model
Meshing and assignment of material properties
The assembled 3D model was imported into the Abaqus 6.14 system and meshed to establish a finite element mesh model of the hip joint.The model of the hip joint contains 61,044 nodes and 3,72,708 elements. As with details reported by Grecu D [14], cortical bone, cancellous bone and cartilage were made by isotropic, continuous and uniform elastic materials (Table 3).
Table 3
Assignment of material properties
Material | Elastic Modulus(MPa) | Poisson's ratio |
Cortical bone | 15100 | 0.3 |
Cancellous bone | 4457 | 0.22 |
Cartilage | 10.5 | 0.45 |
Necrotic tissue | 124.6 | 0.152 |
Boundary conditions and loading force settings
The 6 degrees of freedom that constrained the pelvic joint and the pubic bone were zero. The articular surfaces were set in a frictionless contact relationship. According to Sverdlova et al. [15], 6 muscle forces were loaded on the coupling surfaces corresponding to the attachment point with the axial connection force (Table 4). Based on the settings reported by Brown et al. [16], the joint force was 1.6 times the body weight and loaded on the rigid body of the distal femur. (Fig. 5).The relationship between the femoral cartilage and the acetabular cartilage was set as friction, and the coefficient of friction was 0.2. The relationship of other model parts were set as the binding relation.The results of convergence test for the element size showed that the errors were below 10%.
Table 4
Muscle | Adductor longus | Pestineus | Gluteus maximus | Gluteus medius | Gluteus minimus | Piriformis |
Myodynamia(N) | 560 | 500 | 550 | 700 | 300 | 500 |
Experimental indicators
The VM stress distribution in the cartilage and cortical bone in the femoral head were observed and recorded. In order to study the stress distribution of the necrotic area in necrotic models, the unit area of the overlapped necrotic tissue in necrotic and non-necrotic models was defined as the N-unit area. The VM stress distribution of the N-unit area was also observed and recorded.