Augmented Reality Navigation-Guided Core Decompression for Osteonecrosis of Femoral Head

Summary

Augmented reality technology was applied to core decompression for osteonecrosis of the femoral head to realize real-time visualization of this surgical procedure. This method can effectively improve the safety and precision of core decompression.

Abstract

Osteonecrosis of the femoral head (ONFH) is a common joint disease in young and middle-aged patients, which seriously burdens their lives and work. For early-stage ONFH, core decompression surgery is a classical and effective hip preservation therapy. In traditional procedures of core decompression with Kirschner wire, there are still many problems such as X-ray exposure, repeated puncture verification, and damage to normal bone tissue. The blindness of the puncture process and the inability to provide real-time visualization are crucial reasons for these problems.

To optimize this procedure, our team developed an intraoperative navigation system on the basis of augmented reality (AR) technology. This surgical system can intuitively display the anatomy of the surgical areas and render preoperative images and virtual needles to intraoperative video in real-time. With the guide of the navigation system, surgeons can accurately insert Kirschner wires into the targeted lesion area and minimize the collateral damage. We conducted 10 cases of core decompression surgery with this system. The efficiency of positioning and fluoroscopy is greatly improved compared to the traditional procedures, and the accuracy of puncture is also guaranteed.

Introduction

Osteonecrosis of the femoral head (ONFH) is a common disabling disease occurring in young adults¹. Clinically, it is necessary to determine the staging of ONFH based on X-ray, CT, and MRI to decide the treatment strategy (Figure 1). For early-stage ONFH, hip preservation therapy is usually adopted². Core decompression (CD) surgery is one of the most frequently used hip preservation methods for ONFH. Certain curative effects of core decompression with or without bone grafting in treating early-stage ONFH have been reported, which can avoid or delay subsequent total hip arthroplasty (THA) for a long time^3,4,5. However, the success rate of CD with or without bone grafting was reported differently among previous studies, from 64% to 95%^6,7,8,9. The surgical technique, especially the accuracy of drilling position, is important for the success of hip preservation¹⁰. Due to the blindness of the puncture and positioning procedure, the traditional techniques of CD have several problems, such as more fluoroscopy time, repeated puncture using Kirschner wire, and injury of normal bone tissue^11,12.

In recent years, the augmented reality (AR)-assisted method has been introduced in orthopedic surgery¹³. The AR technique can visually show the anatomy of the surgical field, guide the surgeons in planning the operating procedure, and consequently reduce the difficulty of the operation. The applications of the AR technique in pedicle screw implantation and joint arthroplasty surgery have been reported earlier^14,15,16,17. In this study, we aim to apply the AR technique to the CD procedure and verify its safety, accuracy, and feasibility in clinical practice.

System hardware components
The main components of the AR-based navigation surgical system include the following: (1) A depth camera (Figure 2A) installed directly above the surgical area; the video is shot from this and sent back to the workstation for registration and cooperation with the imaging data. (2) A puncture device (Figure 2B) and a non-invasive body surface marking frame (Figure 2C), both with passive infrared reflectors. A special reflective coating of marking balls (Figure 3) can be captured by infrared equipment to achieve accurate tracking of surgical equipment in the surgical area. (3) An infrared positioning device (Figure 2D) is responsible for tracking markers in the surgical area, matching the body surface marking frame and puncture device with high accuracy (Figure 4). (4) The host system (Figure 2E) is a 64-bit workstation, installed with the independently developed AR-assisted orthopedic surgery system. Augmented reality display of hip joint and femoral head puncture operation can be completed with its assistance.

Protocol

This study was approved by the ethics committee of the China-Japan Friendship Hospital (approval number: 2021-12-K04). All of the following steps were performed according to standardized procedures to avoid injury to the patients and the surgeons. Informed patient consent was obtained for this study. The surgeon must be skilled in conventional core decompression procedures to ensure that the surgery can be performed in a traditional way in case of inaccurate navigation or other unexpected situations.

1. Preoperative diagnosis and grading of ONFH

1. Identify patients with clinical symptoms of ONFH; typical symptoms such as persistent or intermittent pain in the groin region with ipsilateral hip or knee radiating pain. Physical examination showed deep tenderness in the groin region, Patrick's sign, a limited hip motion of internal rotation and abduction, or necrosis changes of the femoral head measured using X-ray, CT, and MRI.
2. According to the association research circulation osseous (ARCO) staging, review patients' X-ray, CT, and MRI of the hip and determine the staging of ONFH. Two doctors conduct this work independently. If disagreements arise, ask a third expert to make the final decision.
3. Record the preoperative visual analogue scale (VAS) and Harris hip score using a questionnaire.
4. Include patients using the following criteria: 1) patients with ONFH; 2) stage I, IIA, and IIB of ONFH confirmed by imaging examination (X-ray, CT, and MRI); 3) the femoral head core decompression surgery is planned. Exclude patients when: 1) patients reject the CD surgery; 2) preoperative routine examination indicates surgical contradictions, such as infection or poor basic condition; 3) patients refuse to be enrolled in the group.

2. System registration and accuracy testing

1. Run the AR-assisted orthopedic surgery system (due to commercialization issues software details cannot be provided) and click on Orthographic Video to activate the depth camera. An image of the surgical area will be displayed on the screen after activation (Figure 5A). Position the optical tracking device so that its tracking area can completely cover the surgical area (Figure 5B).
2. Click on NDI Setting to select the device access port, COM4. Click the Virtual Needle Length Setting (generally a Kirschner needle is 180 mm long) and a virtual Kirschner needle image will be automatically generated in the surgical area in the video.
3. Divide the planned surgical frontal area into upper and lower levels with each level 30 cm x 30 cm in size, and with a height difference of 15 cm between the levels. The system automatically inputs this spatial information of the surgical area in the software.
4. Evenly allocate every level with 10 matching points; for every 30 cm x 30 cm area, divide it into three equal parts, with two parts having three points each, and one part (left part) having four points. Ask the assistant to place the non-invasive body surface marking frame (Figure 2C) according to the points. Once done, click on Match. The system's own special image for registration will be automatically superimposed on the marking frame (Figure 5C). Consider the registration of this point successful when the image and the marking frame coincide completely.
5. Move the frame to the next registration point and repeat step 2.4. until all registration points are completed. As the shape of the marking frame equipped with the puncture device (Figure 3A2) is exactly the same as the non-invasive body surface marking frame, once the registration is completed, the former can also be tracked by the optical tracking device in the surgical area.
6. Move the puncture device randomly in the surgical area to detect the matching degree of virtual needle and tracking delay (Figure 6). As the red-blue virtual Kirschner needle body automatically fits with the actual needle in the surgical area, the augmented reality display of the Kirschner needle is successful (Figure 5D).
   NOTE: During the registration process, the position of the optical tracking device and depth camera should not be changed at will. If so, the spatial position relationship of virtual surgery will change, causing inaccurate matching between the virtual Kirschner needle and the physical one, and registration has to be re-conducted.

3. Patient and system preparation before puncture

1. After entering the operating room, ask the patient to lie down in supine position and fix the lower limb of the affected side (Figure 7). Administer general anesthesia to all patients.
2. Prepare the surgical site with iodine and 75% alcohol, and place the non-invasive body surface positioning device (sterilized using standard procedures) on the patient's affected hip.
3. Move the C-ARM fluoroscope to the side of the operating table and position the source above the hip joint. Align the source with the depth camera and record the position of the surgical table as position 1.
4. After the first fluoroscopy, export the BMP format radiograph to the system workstation, open it in Photo Editing, and adjust its gray scale by clicking on the Light Scale Option. Rotate clockwise and flip horizontally once by clicking the corresponding buttons to convert to BMP. Then, open it by clicking Painting 3D and save as the JPG format, which contained non-invasive body surface marking frame, and name it image 1 (Figure 8A).
   NOTE: This conversion process is to promote the success of the system identification. Because of the special requirements of image conversion, it is necessary to adjust the gray scale of the X-ray image for rotation and inversion.
5. Slide the operating table directly below the depth camera to the operating area marked as position 2. Position 1 (in step 3.3) and position 2 are two points on the same horizontal plane, 30 cm apart.
6. In the AR-assisted orthopedic surgery system, click File > Front X-ray image, and select image 1. the system automatically identifies the non-invasive body surface marking frame on the skin surface of the patient, and then superimposes this image to the hip joint in the surgical video (Figure 8B).
7. Using the augmented reality display of the X-ray image and real-time video generated above, the surgeon plans the puncture path based on this.

4. Puncture assisted by surgical system

1. The surgeon stands on the affected side and performs the following steps. Hold the puncture device and determine the best insertion angle. Mark the insertion point on the skin surface, guided by the virtual Kirschner wire and the X-ray image of the hip joint in the surgical video.
2. Select a Kirschner wire with a diameter of 2.5 mm and pierce it from the insertion point. Observe the insertion depth and angle in the video and adjust it timely.
3. When the virtual needle has reached the target area of necrosis, stop the puncture process and retain the screen shot as image 2 (Figure 9A) for subsequent puncture accuracy evaluation.
4. Indwell the needle. Move the operating table to position 1 for the second fluoroscopy to verify the actual puncture condition of the Kirschner wire. Record the image file as image 3 (Figure 9B).
5. Puncture is successful when the location of the Kirschner wire meets all of the surgeon's requirements. Then, use the lancet to cut the skin around the needle, and separate every level of soft tissue till exposing sub-trochanter bone, roughly to a depth of 3 cm. Drill into the necrotic area along the Kirschner wire with a 5 mm trephine to complete the subsequent operations (artificial bone or autologous bone implantation).
6. After finishing all the procedures, close the skin with 3-0 silk thread and cover with sterile dressing (Figure 10). After returning to the ward, provide the patients accepted common orthopedic postoperative medication, like infection prevention, analgesia, and fluid infusion. If no complication occurs, discharge the patients 3 days after surgery.

5. Operation evaluation

1. Import image 2 and image 3 into an image processing software and adjust the opacity to 52%.
2. Click the Masking button to overlap the two images, then click the Rulers button to measure the distance (L_virtual) between the virtual tip and the puncture point of the femoral cortex, and the distance (L_ture) between the tip of the Kirschner needle and the puncture point of the femoral cortex. Calculate the difference between L_virtual and L_ture to assess puncture accuracy.
3. During the puncture, measure the positioning time as follows: the positioning time starts from the time when the Kirschner wire pierces the skin, and stops when the X-ray confirms that the Kirschner wire has successfully reached the target area of the femoral head.
4. Three months after surgery, take the hip X-ray (Figure 11) and record the visual analogue scale and Harris hip score.

Results

Operation characteristics
The surgical navigation system was applied in continuative 10 hips of nine patients. The average total positioning time of the surgery was 10.1 min (median 9.5 min, range 8.0-14.0 min). The mean C-ARM fluoroscopies was 5.5 times (median 5.5 times, range 4-8 times). The mean error of puncture accuracy was 1.61 mm (median 1.2 mm, range -5.76-19.73 mm; Table 1). The results show that the positioning time and fluoroscopy times are obviously shortened compared ...

Discussion

Although THA has developed rapidly in recent years and become an effective ultimate method for ONFH, hip preservation therapy still plays an important role in treating early-stage ONFH^18,19. CD is a basic and effective hip preservation surgery, which can release hip pain and delay the development of femoral head collapse²⁰. The puncture positioning of the focal necrosis is the crucial procedure of CD, as it determines the success or failur...

Materials

Name	Company	Catalog Number	Comments
AR-assisted Orthopedic Surgery System	Self development	None	An operating software that implements AR for orthopedic surgery
Depth camera	Stereolabs	ZED depth camera(ZED mini)	shoot video and sent back to the workstation.
Image processing software	Adobe Systems Incorporated	Adobe Photoshop CS6	Image processing software
Infrared positioning device	Northern Digital Inc.	NDI Polaris Spectra optical tracking device	Tracking markers in the surgical area.
Puncture device	Stryker	Stryker System 7 Cordless driver and Sabo	Insert kirschner wire into the necrotic area.