CN107303200B - Femur side marking system in hip joint replacement operation and manufacturing method thereof - Google Patents
Femur side marking system in hip joint replacement operation and manufacturing method thereof Download PDFInfo
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- CN107303200B CN107303200B CN201610256500.0A CN201610256500A CN107303200B CN 107303200 B CN107303200 B CN 107303200B CN 201610256500 A CN201610256500 A CN 201610256500A CN 107303200 B CN107303200 B CN 107303200B
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Abstract
The present disclosure relates to a femoral side marker system in hip replacement surgery and a method of making the same. The system comprises: an attachment device including an attachment part attached to a proximal end of a femur and made according to an anatomical form of the proximal end of the femur, a guide connection part provided on the attachment part, and a dial attached to the attachment part; a femoral medullary cavity center marker installed on the guide connection part and used for indicating the direction of the femoral medullary cavity center so as to install a femoral prosthesis; and a femoral head rotation center marking device which is arranged on the femoral prosthesis and is used for determining the femoral head rotation center of the femoral prosthesis according to the position relation with the dial.
Description
Technical Field
The disclosure relates to the field of medical instruments, in particular to a femoral side marking system in hip joint replacement surgery and a manufacturing method thereof.
Background
Artificial hip replacement is one of the most common surgical methods in osteoarthrosis, and about 50 thousands of patients who receive the surgery every year in China. Pain and dysfunction caused by arthritis, trauma, femoral head necrosis and the like can be obviously relieved through joint replacement. In the operation, the reconstruction of the rotation center of the femoral head is vital, and the ideal rotation center can ensure the equal length of limbs and the eccentricity of the femur, and reduce lameness, pain and the abrasion of a prosthesis. The current position of the femoral head rotation center is usually measured according to a preoperative template, and an effective monitoring means is lacked in the operation, so the accuracy and the curative effect of the operation need to be improved urgently.
Disclosure of Invention
It is an object of embodiments of the present disclosure to provide a femoral side marking system in hip replacement surgery, and accordingly, a method of making a femoral side marking system in hip replacement surgery.
According to one aspect of the present disclosure, there is provided a femoral side marker system in hip replacement surgery, comprising:
an attachment device including an attachment part attached to a proximal end of a femur and made according to an anatomical form of the proximal end of the femur, a guide connection part provided on the attachment part, and a dial attached to the attachment part;
a femoral medullary cavity center marker installed on the guide connection part and used for indicating the direction of the femoral medullary cavity center so as to install a femoral prosthesis; and
and the femoral head rotation center marking device is arranged on the femoral prosthesis and is used for determining the femoral head rotation center of the femoral prosthesis according to the position relation with the dial.
According to an embodiment of the present disclosure, the proximal femur comprises at least one of: greater trochanter, lesser trochanter, intertrochanteric crest, and the bare zone, wherein the bare zone is the area on the lateral surface of the greater trochanter of the femur where tendons and ligaments are not attached.
According to one embodiment of the present disclosure, the attachment portion is provided with a dial insertion groove for mounting the dial, and the attachment portion is further provided with a provisional fixation hole for provisional fixation to the proximal end of the femur.
According to an embodiment of the present disclosure, the guide connection part includes a guide connection post, and a direction of the guide connection post is consistent with a running direction of the femoral medullary cavity.
According to one embodiment of the disclosure, the femoral medullary cavity center marker is a rod-like or bar-like structure for enabling an operator to ream by referring to the direction indicated by the femoral medullary cavity center marker so as to install the femoral prosthesis.
According to one embodiment of the disclosure, the operator drives a femoral trial file after reaming, and after the femoral medullary cavity center marking device is removed, a femoral stem trial, a femoral neck trial and a femoral small head trial in the femoral prosthesis are installed on the femoral side.
According to one embodiment of the present disclosure, a grid-shaped scale mark line is provided on the dial, the grid-shaped scale mark line having an axial direction indicating line and a center mark point.
According to one embodiment of the disclosure, the dial is laminar and the direction of the axial indicator line coincides with the direction of the progression of a femoral neck trial in the femoral prosthesis.
According to one embodiment of the present disclosure, the femoral head rotation center marking device includes a hollow hemisphere and an indicator scale, the hollow hemisphere is installed on a femoral small head trial model in the femoral prosthesis.
According to one embodiment of the present disclosure, the indicator scale is of a unitary construction with the hollow hemisphere, the indicator scale having an axial indicator line and an indicator point at the end.
According to one embodiment of the present disclosure, the inner diameter of the hollow hemisphere is adapted to the diameter of the femur small head trial, and the indicator scale is thin-sheet-shaped.
According to an embodiment of the present disclosure, the femoral head rotation center marking device determining the femoral head rotation center of the femoral prosthesis according to the positional relationship with the dial includes:
when an axial index line of the indication scale overlaps with an axial index line of the dial, and an index point of an end of the indication scale overlaps with a central index point of the dial, a spherical center of the hollow hemisphere is determined as a femoral head rotation center of the femoral prosthesis.
According to one embodiment of the disclosure, when the axial marking line of the indication scale is not overlapped with the axial indicating line of the dial, or the indicating point at the tail end of the indication scale is not overlapped with the central marking point of the dial, the size of a femoral stem trial in the femoral prosthesis and/or the neck length of the femoral small head trial are changed.
According to one embodiment of the present disclosure, the digital model of the femoral-side marking system in hip replacement surgery is predetermined from image data of a preoperative patient.
According to an embodiment of the present disclosure, the image data includes MRI data and/or CT data, and the femoral head rotation center of the femoral prosthesis preset in the digital model is set with reference to the image data of the affected side and/or healthy side of the femur.
According to an embodiment of the present disclosure, a spatial positional relationship of the attachment portion, and the guide connection portion and the dial insertion groove for mounting the dial provided on the attachment portion is determined in advance according to the digital model.
According to an embodiment of the present disclosure, the attachment portion is previously manufactured by 3D printing based on the digital model, and the direction of the dial insertion groove coincides with the direction of the course of the base portion of the femoral neck trial of the femoral prosthesis.
According to one aspect of the present disclosure, there is provided a method of making a femoral side marker system in hip replacement surgery, comprising:
pre-determining a digital model of a femoral side marking system in a hip replacement operation according to image data of a preoperative patient;
manufacturing an attachment device according to the digital model, wherein the attachment device comprises an attachment part, a guide connecting part and a dial, the attachment part is attached to the proximal end of the femur and manufactured according to the anatomical form of the proximal end of the femur, the guide connecting part is arranged on the attachment part, and the dial is installed on the attachment part;
making a femoral medullary cavity center marker device according to the digital model, wherein the femoral medullary cavity center marker device is installed on the guide connecting part and is used for indicating the direction of the femoral medullary cavity center so as to install a femoral prosthesis;
and manufacturing a femoral head rotation center marking device according to the digital model, wherein the femoral head rotation center marking device is installed on the femoral prosthesis and is used for determining the femoral head rotation center of the femoral prosthesis according to the position relation with the dial.
According to an embodiment of the present disclosure, the proximal femur comprises at least one of: greater trochanter, lesser trochanter, intertrochanteric crest, and the bare zone, wherein the bare zone is the area on the lateral surface of the greater trochanter of the femur where tendons and ligaments are not attached.
According to one embodiment of the present disclosure, the attachment portion is provided with a dial insertion groove for mounting the dial, and the attachment portion is further provided with a provisional fixation hole for provisional fixation to the proximal end of the femur.
According to an embodiment of the present disclosure, the guide connection part includes a guide connection post, and a direction of the guide connection post is consistent with a running direction of the femoral medullary cavity.
According to one embodiment of the disclosure, the femoral medullary cavity center marker is a rod-like or bar-like structure for enabling an operator to ream by referring to the direction indicated by the femoral medullary cavity center marker so as to install the femoral prosthesis.
According to one embodiment of the disclosure, the operator drives a femoral trial file after reaming, and after the femoral medullary cavity center marking device is removed, a femoral stem trial, a femoral neck trial and a femoral small head trial in the femoral prosthesis are installed on the femoral side.
According to one embodiment of the present disclosure, a grid-shaped scale mark line is provided on the dial, the grid-shaped scale mark line having an axial direction indicating line and a center mark point.
According to one embodiment of the disclosure, the dial is laminar and the direction of the axial indicator line coincides with the direction of the progression of a femoral neck trial in the femoral prosthesis.
According to one embodiment of the present disclosure, the femoral head rotation center marking device includes a hollow hemisphere and an indicator scale, the hollow hemisphere is installed on a femoral small head trial model in the femoral prosthesis.
According to one embodiment of the present disclosure, the indicator scale is of a unitary construction with the hollow hemisphere, the indicator scale having an axial indicator line and an indicator point at the end.
According to one embodiment of the present disclosure, the inner diameter of the hollow hemisphere is adapted to the diameter of the femur small head trial, and the indicator scale is thin-sheet-shaped.
According to an embodiment of the present disclosure, the femoral head rotation center marking device determining the femoral head rotation center of the femoral prosthesis according to the positional relationship with the dial includes:
when an axial index line of the indication scale overlaps with an axial index line of the dial, and an index point of an end of the indication scale overlaps with a central index point of the dial, a spherical center of the hollow hemisphere is determined as a femoral head rotation center of the femoral prosthesis.
According to one embodiment of the disclosure, when the axial marking line of the indication scale is not overlapped with the axial indicating line of the dial, or the indicating point at the tail end of the indication scale is not overlapped with the central marking point of the dial, the size of a femoral stem trial in the femoral prosthesis and/or the neck length of the femoral small head trial are changed.
According to an embodiment of the present disclosure, the image data includes MRI data and/or CT data, and the femoral head rotation center of the femoral prosthesis preset in the digital model is set with reference to the image data of the affected side and/or healthy side of the femur.
According to an embodiment of the present disclosure, a spatial positional relationship of the attachment portion, and the guide connection portion and the dial insertion groove for mounting the dial provided on the attachment portion is determined in advance according to the digital model.
According to an embodiment of the present disclosure, the attachment portion is previously manufactured by 3D printing based on the digital model, and the direction of the dial insertion groove coincides with the direction of the course of the base portion of the femoral neck trial of the femoral prosthesis.
The embodiments of the present disclosure can provide a femoral side marking system in hip replacement surgery and a method for manufacturing the same, which can provide intuitive and quantifiable intraoperative measurement indexes, and facilitate selection of the most suitable femoral prosthesis (e.g., selection of the most suitable femoral stem and femoral head model to form the best matching ratio), thereby completing reconstruction of the closest anatomical position (e.g., reconstruction of femoral head rotation center), improving the accuracy of the surgery, and further improving the efficacy.
Drawings
Embodiments of the present disclosure will now be described, by way of example only, with reference to the accompanying drawings, in which
Fig. 1 is a schematic illustration of a proximal femur anatomy according to an embodiment of the present disclosure;
FIG. 2 is a schematic view of a femoral prosthesis mounted on a proximal end of a femur according to an embodiment of the present disclosure;
FIG. 3 is a schematic structural view of a femoral side marker system in hip replacement surgery mounted on the proximal end of a femur, according to an embodiment of the present disclosure;
FIG. 4 is a schematic structural diagram of an attachment apparatus according to an embodiment of the present disclosure;
FIG. 5 is a schematic structural view of attachment portions at different locations according to an embodiment of the present disclosure;
FIG. 6 is a schematic structural diagram of a femoral medullary cavity center marker device according to an embodiment of the present disclosure;
fig. 7 is a schematic structural view of a femoral head center of rotation marker arrangement according to an embodiment of the present disclosure; and
fig. 8 is a schematic illustration of a method of making a femoral side marker system in hip replacement surgery, according to an embodiment of the present disclosure.
Detailed Description
Embodiments of the present disclosure will now be described in detail with reference to the accompanying drawings. It should be noted that the same reference numerals may be used in the drawings for similar components or functional elements. The accompanying drawings are only intended to illustrate embodiments of the present disclosure. Alternative embodiments will become apparent to those skilled in the art from the following description without departing from the spirit and scope of the disclosure.
As shown in fig. 1, the proximal femur 1 in the present disclosure includes at least one of: greater trochanter 101, lesser trochanter 102, interplanar ridges 103, and a bare area 104, where the bare area 104 is an area on the lateral surface of the greater trochanter of the femur where no tendons and ligaments are attached.
The proximal femur with the femoral marking system of the present disclosure is necessary for hip replacement surgery because the proximal femur is a part with many diseases, such as necrosis of femoral head, tumor and fracture of proximal femur, and includes various anatomical structures such as femoral head 100, femoral neck, trochanter, intertrochanteric, metaphysis and upper femoral shaft. Compared with other joints, the proximal femur anatomical structure is complex and irregular, a large number of multi-directional fluoroscopy operations are often required when the operation of the part is carried out, and the doctor is also required to have rich experience, so that the femoral side marking system in the hip joint replacement operation can reduce the damage of radiation to the patient and the doctor. In addition, the surface of the femoral head is covered with cartilage, and fine blood vessels are arranged around the femoral neck, so that the proximal femur surgery needs greater precision, and once the cartilage or the blood vessels are iatrogenically damaged, femoral head necrosis is aggravated, or osteoarthritis is caused, so that precise operation in bone tissues with complex three-dimensional structures is necessary.
As shown in fig. 2, the femur side marking system in hip replacement surgery of the present disclosure is applied to hip replacement surgery in which an operator (e.g., a physician) needs to reconstruct the femoral head rotation center using a femoral prosthesis 2.
For example, the operator may cut the necrotic femoral head 100, then may drive a femoral trial file along the center of the femoral medullary cavity after reaming, and then mount the femoral stem trial 203, the femoral neck trial 201, and the femoral small head trial 202 of the femoral prosthesis 2 to the femoral side, thereby implementing the mounting of the femoral prosthesis 2, where the rotation center of the femoral head of the mounted femoral prosthesis 2 (i.e., the center of the femoral small head trial 202) is the reconstructed rotation center of the femoral head.
As shown in fig. 3, in order to make the position of the femoral head rotation center reconstructed in fig. 2 accurate, the present disclosure provides a femoral side marking system in hip replacement surgery, which includes an attachment 4, a femoral medullary cavity center marking device 5 and a femoral head rotation center marking device 3.
The attachment device 4 includes an attachment portion 401 attached to the proximal femur 1 and formed according to the anatomical form of the proximal femur 1, a guide connection portion 405 provided on the attachment portion 401, and a dial 402 attached to the attachment portion 401.
A femoral medullary cavity center marker 5 mounted on the guide connection 405 and used to indicate the direction of the femoral medullary cavity center for mounting the femoral prosthesis 2.
The femoral head rotation center marking device 3 is mounted on the femoral prosthesis 2 and is used for determining the femoral head rotation center of the femoral prosthesis 2 according to the position relation with the dial 402.
For example, since the attachment device 4, the femoral medullary cavity center marker 5, and the femoral head rotation center marker 3 can be used to determine the femoral head rotation center of the femoral prosthesis 2, the femoral side marker system in hip replacement surgery of the present disclosure will provide an intuitive and quantifiable intra-operative measurement index, which helps to accurately reconstruct the femoral head rotation center of the femoral prosthesis 2. For example, the most suitable model of the femoral stem trial 203 and the femoral small head trial 202 can be selected to form the best matching (i.e. the combination in the spatial position), complete the reconstruction of the closest anatomical position (e.g. precisely reconstructing the femoral head rotation center), improve the accuracy of the operation, and further improve the curative effect. In addition, the present disclosure may also reduce the number of transillumination or radiographing times during surgery and may reduce the reliance on radiation, thereby protecting patients and physicians from radiation damage. In addition, the embodiments of the present disclosure can also improve the accuracy of the operation, reduce the occurrence of collateral loss and complications, and improve the diagnosis and treatment effect.
For example, the present disclosure can provide customization of a hip replacement surgery personalized femoral side marker measurement system. The system of the present disclosure can also be digitally modeled based on the imaging data of the patient, and then the various devices of the system of the present disclosure, such as the attachment portion 401, etc., can be constructed using 3D printing.
As shown in fig. 4, according to one embodiment of the present disclosure, the attachment device 4 of the present disclosure may be manufactured for different attachment sites (e.g., greater trochanter 101, lesser trochanter 102, intertrochanteric ridge 103, and bare area 104) on the proximal femur 1, and the attachment device 4 may be temporarily fixed by morphological anastomosis.
For example, the attachment portion 401 can be matched with the anatomical shape of the specific part of the proximal femur 1, and in the manufacturing process, firstly, the anatomical data of the proximal femur 1 needs to be obtained through imaging, after the data is calculated, a digital model of the proximal femur 1 can be obtained, then, the model of the attachment portion 401 is calculated to be completely matched with a specific anatomical position of the proximal femur 1, and finally, the attachment portion 401 can be obtained in a 3D printing mode, for example, so that the complete matching with the specific anatomical position of the proximal femur 1 is realized.
As shown in fig. 5, the attachment parts 401 can be made into attachment parts with different structures according to different attachment sites, for example, a bare region attachment part 4013, a large rotor attachment part 4014, a small rotor attachment part 4012 and a rotor ridge attachment part 4011 can be made respectively, and these attachment parts can be selected from one attachment part to attach to a single structure, or a plurality of attachment parts can be selected simultaneously to attach to a plurality of structures, which can be selected according to the needs of diseases and surgeries.
For example, the attachment of the present disclosure can be made as a bare area attachment 4013 that can be attached to a bare area, wherein the bare area is the lateral side of the greater trochanter, the area without tendon and ligament attachment, which is located on the lateral side of the greater trochanter, with the anterior and distal gluteus minimus muscles, the posterior gluteus medius muscle, the proximal piriformis, an area of irregular shape. Because there are no ligamentum tendineum and ligament attachment points, it is easy to identify and obtain an anastomosis of optimal morphology.
For example, the attachment of the present disclosure may be made as a large rotor attachment 4014, which may be attached to a large rotor. Many surgical approaches require the exposure of the large rotor, and in these cases the attachment of the structure can be accomplished using the existing exposure.
For example, the attachment of the present disclosure may be made as a trochanter attachment 4012, which may be attached to a trochanter. Many surgical approaches require the exposure of a small rotor, and in these cases the attachment of the structure can be accomplished using the existing exposure.
For example, the attachment of the present disclosure may be made as an intertrochanteric crest attachment 4011, which may be attached to the intertrochanteric crest of bone. The interrotor ridge is: the large and small rotors respectively extend towards the far end and the near end behind the femur to form a continuous bone ridge, and the anatomical form of the part is unique and irregular, so that the optimal anastomosis is easily obtained.
As shown in fig. 4, the attachment portion 401 is provided with a dial insertion groove 407 for mounting the dial 402, and the attachment portion 401 is also provided with a provisional fixation hole 406 for provisional fixation to the proximal femur 1.
For example, the attachment portion 401 has a temporary fixing hole 406, and the attachment portion 401 can be temporarily fixed to the proximal femur 1 through the temporary fixing hole 406, which facilitates the stability of the operation.
As shown in fig. 4, the guide connection 405 includes a guide connection post, which is oriented in the same direction as the femoral medullary cavity.
For example, the attachment portion 401 has a guiding post oriented to coincide with the direction of travel of the medullary cavity, which can be calculated with reference to the CT data of the proximal femur 1. The guiding connection column can be connected with the femoral medullary cavity center marker 5 in a certain way (such as a snap connection).
As shown in fig. 6, the femoral medullary cavity center marker 5 has a rod-like or bar-like structure for allowing an operator to ream with reference to the direction indicated by the femoral medullary cavity center marker 5 to install the femoral prosthesis.
For example, since the direction of the guide connection portion 405 (e.g., the guide connection column) is the same as the running direction of the femoral medullary cavity, the direction indicated by the femoral medullary cavity center marker 5 installed on the guide connection portion 405 (e.g., the guide connection column) is the running direction of the femoral medullary cavity, so that the femoral prosthesis installed after reaming can keep accurate positioning in the running direction of the femoral medullary cavity, thereby ensuring accurate positioning of the femoral head rotation center by the dial 402 and the indication scale 302.
As shown in fig. 3 and 6, the operator drives a femoral trial file after reaming, and after removing the femoral medullary cavity center marker 5, mounts a femoral stem trial 203, a femoral neck trial 201 and a femoral small head trial 202 of the femoral prosthesis to the femoral side as shown in fig. 2 and 3.
For example, the size of the femoral stem trial 203, the femoral neck trial 201 and the femoral small head trial 202 can be various models, and different size and model combinations can be formed by replacing the femoral stem trial 203, the femoral neck trial 201 and the femoral small head trial 202 with different sizes and models, so that the spatial structure of the femoral stem trial can be changed, and the dial 402 and the indicating scale 302 can be conveniently and subsequently utilized to adjust the spatial position to accurately position the femoral head rotation center.
As shown in fig. 3 and 4, the dial 402 is provided with grid-like scale marks having an axial direction indicating line 403 and a center index point 404.
For example, the attachment part 401 is provided with a scale insertion groove 407, the scale 402 can be connected by the scale insertion groove 407, the scale 402 has a sheet shape, the direction of travel of the axial direction indication line 403 of the scale 402 coincides with the direction of the femoral neck trial 201 on the femoral prosthesis 2, and the scale 402 has the axial direction indication line 403 and the center mark point 404. In the measurement, the axial direction indicator line 403 of the dial should be parallel to the axial direction indicator line 403 on the indicator scale 302 in the femoral head rotation center marker 3.
As shown in fig. 3 and 4, the scale 402 is in the form of a thin plate, and the direction of the axial direction indicator line 403 coincides with the direction of travel of the femoral neck trial 201 in the femoral prosthesis 2.
For example, when the dial 402 is in the form of a sheet, it can be positioned in space (for example, whether the positions are aligned) in cooperation with the sheet-like indication scale 302, which facilitates the actual operation. For example, the overall structure of the femoral neck trial 201 is at an angle (e.g., 126 degrees, 135 degrees, 130 degrees, etc.) to the femoral stem trial 203, and the direction of the axial indicator 403 is aligned with the direction of travel of the overall structure of the femoral neck trial 201 (i.e., at the same angle as the femoral stem trial 203).
As shown in fig. 3 and 7, the femoral head rotation center marking device 3 includes a hollow hemisphere 301 and an indication scale 302, and the hollow hemisphere 301 is mounted on the femoral small head trial 202 in the femoral prosthesis 2.
For example, the inner diameter of the hollow hemisphere 301 in the femoral head rotation center marking device 3 is consistent with the outer diameter of the small head trial 202, and after the small head trial 202 is placed, the hollow hemisphere 301 can be sleeved outside the small head trial 202. Meanwhile, an axial indication line 403 in the indication scale 302 is parallel to the axial indication line 403 on the dial 402, and a numerical value can be read from the dial 402 corresponding to an indication point at the tail end of the indication scale 302, so that the position difference between the femoral head rotation center reconstructed in the state and an ideal rotation center can be obtained.
For example, the femoral head rotation center marking device 3 can perform digital processing (e.g., establishing a digital model of the femoral head rotation center marking device 3) by referring to the imaging data of the affected side and/or the healthy side, so as to obtain the spatial parameters of the ideal femoral head rotation center after reconstruction. The femoral head rotational center marker 3 comprising the hollow hemisphere 301 and the indicator scale 302 may then be fabricated, for example, by 3D printing. During operation, the attachment device 4 can be temporarily fixed, then a femoral stem trial model and a femoral small head trial model are installed, and then the difference between the actual rotation center and the ideal rotation center is displayed by using the dial 402 and the indication scale 302, so that the selection of the model of the femoral stem trial model and the model of the femoral small head trial model is guided. The attachment device 4 can be simultaneously connected with the femoral medullary cavity center marking device 5, which is beneficial to controlling the neutral position of the femoral stem trial. Therefore, the method can improve the accuracy of femoral side reconstruction (such as femoral head rotation center) in hip joint replacement, is beneficial to solving the main complication that the limbs are unequal in length after hip joint replacement, and can also give consideration to femoral eccentricity and improve the curative effect.
As shown in fig. 3 and 7, the indication scale 302 is of a unitary structure with the hollow hemisphere 301, the indication scale 302 having an axial marking line 303 and an indication point at the end.
The hollow hemisphere 301 has an inner diameter corresponding to the diameter of the femoral small head trial 202 in the femoral prosthesis, and the indicator scale 302 has a sheet-like shape.
As shown in fig. 3 and 7, the determining the femoral head rotation center of the femoral prosthesis 2 by the femoral head rotation center marking device 3 according to the position relationship with the scale 402 includes:
when the axial index line 303 of the indication scale 302 overlaps the axial index line 403 of the scale 402, and the index point of the end of the indication scale 302 overlaps the central index point 404 of the scale 402, the center of sphere of the hollow hemisphere 301 is determined as the femoral head rotation center of the femoral prosthesis 1.
As shown in fig. 3 and 7, the size of the femoral stem trial 203 and/or the neck length of the femoral small head trial 202 in the femoral prosthesis 2 is changed when the axial direction mark line 303 of the indication scale 302 does not overlap the axial direction mark line 403 of the scale 402 or when the mark point of the end of the indication scale 302 does not overlap the central mark point 404 of the scale 402.
For example, the size of the femoral stem trial 203 and/or the neck length of the femoral small head trial 202 in the femoral prosthesis 2 can be changed by replacing the size of the femoral stem trial 203 and the size of the femoral small head trial 202, so that the size of the finally combined femoral stem trial 203 and the femoral small head trial 202 can make the axial marking line 303 of the indication scale 302 overlap with the axial indication line 403 of the dial 402 and the indication point of the end of the indication scale 302 overlap with the central marking point 404 of the dial 402, and the center of the hollow hemisphere 301 is determined as the femoral head rotation center of the femoral prosthesis 1.
As shown in fig. 3, a digital model of the femoral side marker system in hip replacement surgery is predetermined based on image data of the preoperative patient.
The image data comprises MRI data and/or CT data, and the femoral head rotation center of the femoral prosthesis preset in the digital model is set by referring to the image data of the affected side and/or healthy side of the femur.
The attachment portion 401, and the spatial positional relationship between the guide connection portion 405 provided on the attachment portion 401 and the dial insertion groove 407 for attaching the dial 402 are predetermined based on the digital model.
The attachment portion 401 is previously manufactured by 3D printing on the digital model, and the direction of the dial insertion groove 407 matches the direction of travel of the base portion 204 of the femoral neck mold 201 of the femoral prosthesis 1.
For example, the femoral neck trial 201 of each femoral prosthesis runs at different angles, such as 126 degrees, 135 degrees, 130 degrees, etc. with respect to the femoral neck trial 201 and the femoral stem trial 203, while the base portion 204 of the femoral neck trial 201 is located at the junction of the femoral neck trial 201 and the femoral stem trial 203, and the direction thereof may be perpendicular to the direction of the axial indication line 403, for example, when the scale 402 is manufactured, different scales 402 may be manufactured (for example, different scale slots 407 may be manufactured, and different axial indication lines 403 may be manufactured) according to different femoral prostheses (for example, combinations of different types of femoral neck trials 201 and different types of femoral stem trials 203).
Fig. 8 illustrates a schematic diagram of a method of making a femoral side marker system in hip replacement surgery, according to an embodiment of the present disclosure.
As shown, in step 100, a digital model of a femoral marking system in hip replacement surgery is predetermined based on image data of a preoperative patient.
For example, step 100 may be implemented by the following process:
1, imaging examination: the patient undergoes nuclear magnetic and CT examinations to obtain imaging data of the proximal femur, and the data is stored in an image storage system (such as a PICS system) of the hospital.
Importing imaging data: the imaging data of the patient is imported into the image processing system (e.g. dedicated image processing system software, which may utilize existing software (such as mics software), or develop corresponding programs) by using media such as optical disc, usb disk, or network.
3, establishing an anatomical digital model: and establishing important reference marks by adopting a method of combining intelligent automatic marking and manual marking. And establishing a digital model of proximal femur anatomy. The anatomical structures involved may be cartilage, bony or soft tissue.
4, determining an important reference position: these important reference positions include the greater trochanter, the lesser trochanter, the posterior trochanter ridge of the femur, the lateral surface of the greater trochanter, and the like. Different combinations of reference positions may be used depending on the different approaches to the procedure.
5, establishing a digital model of a femur side marking system in the hip joint replacement surgery:
(1) establishing a digital model of the attachment device: according to the anatomical digital model, a digital model of the attachment means is established based on the determined significant reference positions.
(2) Setting the expected center of rotation: the determination of the center of rotation is expected to follow the basic principles of hip replacement, with reference to the patient's actual condition. For unilateral lesions, contralateral normal cases, it is expected that the center of rotation can be referenced to the contralateral side. In the case of bilateral co-morbidities, the expected center of rotation of the femoral head can be calculated based on other anatomical structures at the proximal end of the femur, or the characteristics of the particular disease.
(3) Customizing the femoral side marker system in hip replacement surgery: and establishing a digital model of the femoral side marking system in the hip replacement surgery according to the expected three-dimensional space parameters of the femoral head rotation center.
In step 102, an attachment device is fabricated from the digital model, the attachment device including an attachment portion attached to the proximal end of the femur and fabricated from an anatomical configuration of the proximal end of the femur, a guide connection portion provided on the attachment portion, and a dial attached to the attachment portion.
For example, the attachment portion, and the guide post and dial slot thereon, may be obtained by means of 3D printing.
In step 104, a femoral medullary cavity center marker is made from the digital model, mounted on the guide connection, and used to indicate the direction of the femoral medullary cavity center for mounting the femoral prosthesis.
For example, the femoral medullary cavity center marker can be obtained by 3D printing or non-printing.
In step 106, a femoral head rotation center marker is made from the digital model, mounted on the femoral prosthesis, and used to determine a femoral head rotation center of the femoral prosthesis from a positional relationship with the dial.
For example, the femoral head rotational center marking device may be obtained in a 3D printing or non-printing manner.
For example, after making the above attachment means, femoral medullary cavity center marker means, and femoral head rotation center marker means, the following surgical operations may be performed: the hip joint is surgically exposed, including the proximal femur, and the attachment device is affixed to a pre-set anatomical structure and temporarily fixed. The medullary cavity center marking device is connected with the guide post of the attachment part, and the direction indicated by the device is the running direction of the proximal medullary cavity center of the femur. The reaming can be performed with reference to this direction to avoid inversion or eversion of the prosthesis (which would have an effect on the service life of the prosthesis), after the medullary cavity is prepared, a femoral trial file is driven, and the medullary cavity center marker is removed. And (5) installing a femoral neck test model and a femoral small head test model. The dial is fixed through the dial insertion slot. The marking device of the femoral head rotation center is sleeved on the femoral small head test model, hollow hemispheres with different inner diameters are selected according to different diameters of the femoral small head test model, an axial indicating line of an indicating scale is parallel to an axial indicating line of a dial, the tip of the indicating scale indicates a point, and the relation between the point and a mark point of the center of a marking disc shows the difference between the femoral head rotation center after reconstruction and the expected ideal rotation center. Based on this difference, the size of the femoral stem trial and/or the neck length of the femoral small head can be adjusted until the best match.
As shown in fig. 4, the attachment portion 401 is provided with a dial insertion groove 407 for mounting the dial 402, and the attachment portion 401 is also provided with a provisional fixation hole 406 for provisional fixation to the proximal femur 1.
For example, the attachment portion 401 has a temporary fixing hole 406, and the attachment portion 401 can be temporarily fixed to the proximal femur 1 through the temporary fixing hole 406, which facilitates the stability of the operation.
As shown in fig. 4, the guide connection 405 includes a guide connection post, which is oriented in the same direction as the femoral medullary cavity.
For example, the attachment portion 401 has a guiding post oriented to coincide with the direction of travel of the medullary cavity, which can be calculated with reference to the CT data of the proximal femur 1. The guiding connection column can be connected with the femoral medullary cavity center marker 5 in a certain way (such as a snap connection).
As shown in fig. 6, the femoral medullary cavity center marker 5 has a rod-like or bar-like structure for allowing an operator to ream with reference to the direction indicated by the femoral medullary cavity center marker 5 to install the femoral prosthesis.
For example, since the direction of the guide connection portion 405 (e.g., the guide connection column) is the same as the running direction of the femoral medullary cavity, the direction indicated by the femoral medullary cavity center marker 5 installed on the guide connection portion 405 (e.g., the guide connection column) is the running direction of the femoral medullary cavity, so that the femoral prosthesis installed after reaming can keep accurate positioning in the running direction of the femoral medullary cavity, thereby ensuring accurate positioning of the femoral head rotation center by the dial 402 and the indication scale 302.
As shown in fig. 3 and 6, the operator drives a femoral trial file after reaming, and after removing the femoral medullary cavity center marker 5, mounts a femoral stem trial 203, a femoral neck trial 201 and a femoral small head trial 202 of the femoral prosthesis to the femoral side as shown in fig. 2 and 3.
For example, the size of the femoral stem trial 203, the femoral neck trial 201 and the femoral small head trial 202 can be various models, and different size and model combinations can be formed by replacing the femoral stem trial 203, the femoral neck trial 201 and the femoral small head trial 202 with different sizes and models, so that the spatial structure of the femoral stem trial can be changed, and the dial 402 and the indicating scale 302 can be conveniently and subsequently utilized to adjust the spatial position to accurately position the femoral head rotation center.
As shown in fig. 3 and 4, the dial 402 is provided with grid-like scale marks having an axial direction indicating line 403 and a center index point 404.
For example, the attachment part 401 is provided with a scale insertion groove 407 through which a scale 402 can be connected, the scale 402 is in a sheet shape, the running direction of the scale 402 coincides with the direction of the femoral neck trial 201 on the femoral prosthesis 2, and the scale 402 has an axial direction indication line 403 and a center mark point 404. In the measurement, the axial direction indicator line 403 of the dial should be parallel to the axial direction indicator line 403 on the indicator scale 302 in the femoral head rotation center marker 3.
As shown in fig. 3 and 4, the scale 402 is in the form of a thin plate, and the direction of the axial direction indicator line 403 coincides with the direction of travel of the femoral neck trial 201 in the femoral prosthesis 2.
For example, when the dial 402 is in the form of a sheet, it can be positioned in space (for example, whether the positions are aligned) in cooperation with the sheet-like indication scale 302, which facilitates the actual operation.
As shown in fig. 3 and 7, the femoral head rotation center marking device 3 includes a hollow hemisphere 301 and an indication scale 302, and the hollow hemisphere 301 is mounted on the femoral small head trial 202 in the femoral prosthesis 2.
For example, the inner diameter of the hollow hemisphere 301 in the femoral head rotation center marking device 3 is consistent with the outer diameter of the small head trial 202, and after the small head trial 202 is placed, the hollow hemisphere 301 can be sleeved outside the small head trial 202. Meanwhile, an axial indication line 403 in the indication scale 302 is parallel to the axial indication line 403 on the dial 402, and a numerical value can be read from the dial 402 corresponding to an indication point at the tail end of the indication scale 302, so that the position difference between the femoral head rotation center reconstructed in the state and an ideal rotation center can be obtained.
For example, the femoral head rotation center marking device 3 can perform digital processing (e.g., establishing a digital model of the femoral head rotation center marking device 3) by referring to the imaging data of the affected side and/or the healthy side, so as to obtain the spatial parameters of the ideal femoral head rotation center after reconstruction. The femoral head rotational center marker 3 comprising the hollow hemisphere 301 and the indicator scale 302 may then be fabricated, for example, by 3D printing. During operation, the attachment device 4 can be temporarily fixed, then a femoral stem trial model and a femoral small head trial model are installed, and then the difference between the actual rotation center and the ideal rotation center is displayed by using the dial 402 and the indication scale 302, so that the selection of the model of the femoral stem trial model and the model of the femoral small head trial model is guided. The attachment device 4 can be simultaneously connected with the femoral medullary cavity center marking device 5, which is beneficial to controlling the neutral position of the femoral stem trial. Therefore, the method can improve the accuracy of femoral side reconstruction (such as femoral head rotation center) in hip joint replacement, is beneficial to solving the main complication that the limbs are unequal in length after hip joint replacement, and can also give consideration to femoral eccentricity and improve the curative effect.
As shown in fig. 3 and 7, the indication scale 302 is of a unitary structure with the hollow hemisphere 301, the indication scale 302 having an axial marking line 303 and an indication point at the end.
The hollow hemisphere 301 has an inner diameter corresponding to the diameter of the femoral small head trial 202 in the femoral prosthesis, and the indicator scale 302 has a sheet-like shape.
As shown in fig. 3 and 7, the determining the femoral head rotation center of the femoral prosthesis 2 by the femoral head rotation center marking device 3 according to the position relationship with the scale 402 includes:
when the axial index line 303 of the indication scale 302 overlaps the axial index line 403 of the scale 402, and the index point of the end of the indication scale 302 overlaps the central index point 404 of the scale 402, the center of sphere of the hollow hemisphere 301 is determined as the femoral head rotation center of the femoral prosthesis 1.
As shown in fig. 3 and 7, the size of the femoral stem trial 203 and/or the neck length of the femoral small head trial 202 in the femoral prosthesis 2 is changed when the axial direction mark line 303 of the indication scale 302 does not overlap the axial direction mark line 403 of the scale 402 or when the mark point of the end of the indication scale 302 does not overlap the central mark point 404 of the scale 402.
For example, the size of the femoral stem trial 203 and/or the neck length of the femoral small head trial 202 in the femoral prosthesis 2 can be changed by replacing the size of the femoral stem trial 203 and the size of the femoral small head trial 202, so that the size of the finally combined femoral stem trial 203 and the femoral small head trial 202 can make the axial marking line 303 of the indication scale 302 overlap with the axial indication line 403 of the dial 402 and the indication point of the end of the indication scale 302 overlap with the central marking point 404 of the dial 402, and the center of the hollow hemisphere 301 is determined as the femoral head rotation center of the femoral prosthesis 1.
As shown in fig. 3, a digital model of the femoral side marker system in hip replacement surgery is predetermined based on image data of the preoperative patient.
The image data comprises MRI data and/or CT data, and the femoral head rotation center of the femoral prosthesis preset in the digital model is set by referring to the image data of the affected side and/or healthy side of the femur.
The attachment portion 401, and the spatial positional relationship between the guide connection portion 405 provided on the attachment portion 401 and the dial insertion groove 407 for attaching the dial 402 are predetermined based on the digital model.
The attachment portion 401 is previously manufactured by 3D printing on the digital model, and the direction of the dial insertion groove 407 matches the direction of travel of the base portion 204 of the femoral neck mold 201 of the femoral prosthesis 1.
For example, the femoral neck trial 201 of each femoral prosthesis runs at different angles, such as 126 degrees, 135 degrees, 130 degrees, etc. with respect to the femoral neck trial 201 and the femoral stem trial 203, while the base portion 204 of the femoral neck trial 201 is located at the junction of the femoral neck trial 201 and the femoral stem trial 203, and the direction thereof may be perpendicular to the direction of the axial indication line 403, for example, when the scale 402 is manufactured, different scales 402 may be manufactured (for example, different scale slots 407 may be manufactured, and different axial indication lines 403 may be manufactured) according to different femoral prostheses (for example, combinations of different types of femoral neck trials 201 and different types of femoral stem trials 203).
The following examples are provided to illustrate the methods of making the femoral marking system of the present disclosure in hip replacement surgery.
This example is an example of a lateral approach hip replacement procedure, which illustrates how to make (e.g., customize) a femoral side marking system for a hip replacement procedure and, with the aid of the system, complete the femoral side replacement for the hip replacement procedure.
1. Imaging examination
The patient is examined by thin-layer CT scanning, and the data is copied in an optical disk after scanning.
2. And (3) importing the data into a personal computer by using an optical disk, opening the Mimics software, and reading the CT data of the patient. And recording bony structures at the level of each axial position through automatic identification and manual correction, and finishing the digital reconstruction of the anatomical structure.
3. And (3) establishing an anatomical digital model by using Mimics software, and determining the position of the expected femoral head rotation center at the operation side in a three-dimensional space. For unilateral lesions, contralateral normal cases, it is expected that the center of rotation can be referenced to the contralateral side. In the case of bilateral co-morbidities, the expected center of rotation of the femoral head can be calculated based on other anatomical structures at the proximal end of the femur, or the characteristics of the particular disease.
4. From the anatomical digital model, a digital model of the femoral-side marker system in hip replacement surgery, in particular of the attachment portion 401 of the attachment device 4, is established. In this embodiment, a rotor ridge attaching portion 4011 is selected, and the inner surface of the attaching portion can be closely attached to the rotor ridge. Other examples may choose the small rotor attachment 4012, the large rotor attachment 4014, or the bare area attachment 4013 as the case may be. A digital model of the attachment portion 401 may be created, including the dial socket 407 and the guide connection 405 (e.g., guide post) thereon, with the orientation of the guide connection 405 (e.g., guide post) indicating the progression of the femoral proximal medullary cavity center.
5. The trochanter ridge attachment 4011 is printed by a 3D printer, and includes the dial socket 407 and the guide connection portion 405 (e.g., guide connection post) thereon, and the direction of the dial socket 407 is parallel to the running of the base portion 204 of the femoral neck trial 201 of the femoral prosthesis 2.
6. By calculation, a suitable scale 402 is selected with grid marking lines, axial indicator lines 403 and a central marker point 404. The direction of its axis indicator 403 is similar to the direction of the femoral neck trial 201 of the femoral prosthesis 2.
7. The posterior-lateral approach is performed to expose the hip joint, including the proximal femur 1, and the trochanteric ridge attachment 4011 and the trochanteric ridge 103 are tightly attached and temporarily fixed through the temporary fixing holes 406. The intramedullary canal center marker 5 is connected to a guide connection 405 (e.g., a guide post) of the attachment portion 401, and the direction indicated by the intramedullary canal center marker 5 is a running direction of the proximal femoral intramedullary canal center. Reaming can be carried out with reference to the direction indicated by the medullary cavity central marker 5 to avoid inversion or eversion of the prosthesis, after the medullary cavity is prepared, a femoral trial file is driven, and the medullary cavity central marker 5 is removed. And (5) installing a femoral neck test model 201 and a femoral small head test model 202. The dial 402 is fixed by the dial insertion slot 407. The femur small head test model 202 is sleeved with a hollow hemisphere 301 (namely a marking device of a femoral head rotation center), the hollow hemisphere 301 with different inner diameters is selected according to different diameters of the femur small head test model 202, an axial indication line 403 of an indication scale 302 is parallel to an axial indication line 403 of a dial 402, the tip of the indication scale 302 indicates a point, and the relationship between the point and a center mark point 404 of the dial 402 shows the difference between the femoral head rotation center after reconstruction and an expected ideal rotation center. For example 3 mm upwards and 1 mm outwards. According to the difference, the size of the femoral stem trial and/or the neck length of the femoral small head trial can be adjusted until the best match is achieved.
8. The attachment 1014 to the greater trochanter 101, the attachment 1012 to the lesser trochanter 104 and the attachment 1013 to the nude area can be selected, either alone or in combination, depending on the surgical approach and the medical needs.
Thus, the manufacturing of the femoral side marking system in the hip joint replacement operation is completed, and the femoral side replacement in the hip joint replacement operation is completed by using the system.
Many modifications and other embodiments of the disclosure set forth herein will come to mind to one skilled in the art to which this disclosure pertains having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. Therefore, it is to be understood that the embodiments of the disclosure are not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the disclosure. Moreover, while the above description and the related figures describe example embodiments in the context of certain example combinations of components and/or functions, it should be appreciated that different combinations of components and/or functions may be provided by alternative embodiments without departing from the scope of the present disclosure. In this regard, for example, other combinations of components and/or functions than those explicitly described above are also contemplated as within the scope of the present disclosure. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.
Claims (33)
1. A femoral side marker system in hip replacement surgery, comprising:
an attachment device including an attachment part attached to a proximal end of a femur and made according to an anatomical form of the proximal end of the femur, a guide connection part provided on the attachment part, and a dial attached to the attachment part;
a femoral medullary cavity center marker installed on the guide connection part and used for indicating the direction of the femoral medullary cavity center so as to install a femoral prosthesis; and
and the femoral head rotation center marking device is arranged on the femoral prosthesis and is used for determining the femoral head rotation center of the femoral prosthesis according to the position relation with the dial.
2. The system of claim 1, wherein the proximal femur comprises at least one of: greater trochanter, lesser trochanter, intertrochanteric crest, and the bare zone, wherein the bare zone is the area on the lateral surface of the greater trochanter of the femur where tendons and ligaments are not attached.
3. The system according to claim 1 or 2, wherein the attachment portion is provided with a dial insertion groove for mounting the dial, and the attachment portion is further provided with a provisional fixing hole for provisional fixing to the proximal end of the femur.
4. System according to claim 1 or 2, wherein the guiding connection comprises a guiding connection column, the direction of which coincides with the direction of the running of the femoral medullary cavity.
5. The system according to claim 4, wherein the femoral medullary cavity center marker is a rod or bar structure for allowing an operator to ream to install the femoral prosthesis with reference to the direction indicated by the femoral medullary cavity center marker.
6. The system according to claim 5, wherein the operator drives a femoral trial file after reaming and installs a femoral stem trial, a femoral neck trial and a femoral small head trial in the femoral prosthesis to the femoral side after removing the femoral medullary cavity center marking device.
7. A system according to claim 1 or 2, wherein the dial is provided with grid-like scale markings having axial indicator lines and a central index point.
8. The system of claim 7, wherein the dial is laminar, and the direction of the axial indicator line coincides with the direction of the progression of a femoral neck trial in the femoral prosthesis.
9. The system of claim 7, wherein the femoral head center of rotation marker comprises a hollow hemisphere and an indicator scale, the hollow hemisphere mounted on a femoral small head trial in the femoral prosthesis.
10. The system of claim 9, wherein the indicator scale is of unitary construction with the hollow hemisphere, the indicator scale having an axial index line and an indicator point at a distal end.
11. The system of claim 10, wherein the hollow hemisphere has an inner diameter corresponding to a diameter of the trial of the femoral small head, and the indicator scale is in the form of a thin plate.
12. The system of claim 10 or 11, wherein the femoral head center of rotation marker determining the femoral head center of rotation of the femoral prosthesis from a positional relationship with the dial comprises:
when an axial index line of the indication scale overlaps with an axial index line of the dial, and an index point of an end of the indication scale overlaps with a central index point of the dial, a spherical center of the hollow hemisphere is determined as a femoral head rotation center of the femoral prosthesis.
13. The system of claim 12, wherein the size of the femoral stem trial in the femoral prosthesis and/or the neck length of the femoral capitulum trial is changed when the axial index line of the indicator scale does not overlap with the axial index line of the dial, or when the index point at the end of the indicator scale does not overlap with the central index point of the dial.
14. The system of claim 1 or 2, wherein the digital model of the femoral-side marking system in hip replacement surgery is predetermined from image data of a preoperative patient.
15. The system of claim 14, wherein the image data includes MRI data and/or CT data, and the femoral head rotation center of the femoral prosthesis preset in the digital model is set with reference to the image data of the affected side and/or healthy side of the femur.
16. The system according to claim 14, wherein a spatial positional relationship of the attachment portion, and the guide connection portion and a dial slot for mounting the dial provided on the attachment portion is predetermined according to the digital model.
17. The system of claim 16, wherein the attachment portion is pre-fabricated by 3D printing from the digital model, and the dial socket is oriented in a direction that coincides with a direction of travel of a base portion of a femoral neck trial of the femoral prosthesis.
18. A method of making a femoral side marker system in hip replacement surgery, comprising:
pre-determining a digital model of a femoral side marking system in a hip replacement operation according to image data of a preoperative patient;
manufacturing an attachment device according to the digital model, wherein the attachment device is used for being attached to the proximal end of the femur and manufactured according to the anatomical form of the proximal end of the femur, and comprises an attachment part, a guide connecting part and a dial, the attachment part is attached to the proximal end of the femur and manufactured according to the anatomical form of the proximal end of the femur, the guide connecting part is arranged on the attachment part, and the dial is installed on the attachment part;
making a femoral medullary cavity center marker device according to the digital model, wherein the femoral medullary cavity center marker device is installed on the guide connecting part and is used for indicating the direction of the femoral medullary cavity center so as to install a femoral prosthesis;
and manufacturing a femoral head rotation center marking device according to the digital model, wherein the femoral head rotation center marking device is installed on the femoral prosthesis and is used for determining the femoral head rotation center of the femoral prosthesis according to the position relation with the dial.
19. The method of claim 18, wherein the proximal femur comprises at least one of: greater trochanter, lesser trochanter, intertrochanteric crest, and the bare zone, wherein the bare zone is the area on the lateral surface of the greater trochanter of the femur where tendons and ligaments are not attached.
20. The method according to claim 18 or 19, wherein the attachment portion is provided with a dial insertion groove for mounting the dial, and the attachment portion is further provided with a provisional fixing hole for provisional fixing to the proximal end of the femur.
21. The method according to claim 18 or 19, wherein the guiding connection comprises a guiding connection post, the direction of which coincides with the direction of the running of the femoral medullary cavity.
22. The method according to claim 21, wherein the femoral medullary cavity center marker is a rod or bar structure for allowing an operator to ream to install the femoral prosthesis with reference to the direction indicated by the femoral medullary cavity center marker.
23. The method of claim 22, wherein the operator drives a femoral trial file after reaming and installs the femoral stem trial, femoral neck trial and femoral small head trial of the femoral prosthesis to the femoral side after removing the femoral medullary cavity center marker.
24. The method according to claim 18 or 19, wherein the dial is provided with grid-like scale markings having axial indicator lines and a central index point.
25. The method of claim 24, wherein the dial is laminar and the direction of the axial indicator line coincides with the direction of the progression of a femoral neck trial in the femoral prosthesis.
26. The method of claim 24, wherein the femoral head center of rotation marker comprises a hollow hemisphere and an indicator scale, the hollow hemisphere mounted on a femoral small head trial in the femoral prosthesis.
27. The method of claim 26, wherein the indicator scale is of unitary construction with the hollow hemisphere, the indicator scale having an axial index line and an indicator point at a distal end.
28. The method of claim 27, wherein the hollow hemisphere has an inner diameter that is compatible with a diameter of the trial of the femoral capitulum, and the indicator scale is lamellar.
29. The method of claim 27 or 28, wherein the femoral head center of rotation marking device determining the femoral head center of rotation of the femoral prosthesis from the positional relationship with the dial comprises:
when an axial index line of the indication scale overlaps with an axial index line of the dial, and an index point of an end of the indication scale overlaps with a central index point of the dial, a spherical center of the hollow hemisphere is determined as a femoral head rotation center of the femoral prosthesis.
30. The method of claim 29, wherein the size of the femoral stem trial in the femoral prosthesis and/or the neck length of the femoral capitulum trial is changed when the axial index line of the indicator scale does not overlap with the axial index line of the dial, or when the index point at the end of the indicator scale does not overlap with the central index point of the dial.
31. The method according to claim 18 or 19, wherein the image data comprises MRI data and/or CT data, and the femoral head rotation center of the femoral prosthesis preset in the digital model is set with reference to the image data of the affected side and/or healthy side of the femur.
32. The method according to claim 18 or 19, wherein a spatial positional relationship of the attachment portion, and the guide connection portion and a dial insertion groove for mounting the dial provided on the attachment portion is predetermined according to the digital model.
33. The method according to claim 32, wherein the attachment portion is pre-fabricated by 3D printing from the digital model, and the dial socket is oriented in a direction corresponding to a running direction of a base portion of a femoral neck trial of the femoral prosthesis.
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