This invention relates to a method of planning a hip arthroplasty. In other examples the invention relates to a method of determining a range of orientation angles for an acetabular cup.
Hip arthroplasty is a surgical procedure in which a prosthetic is implanted in a subject to replace a hip joint. The prosthetic typically emulates the natural ball and socket hip joint by way of a femoral head that rotates within an acetabular cup.
In some cases, subjects experience pain, dislocation or other unsatisfactory functioning of the hip joint after surgery. This can lead to ongoing problems and in some case requires revision surgery.
Surgeons may endeavour to install an acetabular cup within a range of angles generally considered to provide acceptable results. However, even within this range subjects may experience problems such as pain or dislocation.
According to one example there is provided a method of planning a hip arthroplasty for a subject, comprising: receiving at least one image of the subject, wherein the at one least image is substantially acquired from the sagittal plane when the subject is standing; calculating at least one spinopelvic metric from the at least one image; and based on the calculated spinopelvic metrics, calculating a hip arthroplasty risk characteristic of the subject.
According to another example there is provided a method of determining a range of acetabular cup orientation angles for an acetabular cup implant for a subject, comprising: receiving at least one image of the subject, wherein the at one least image is substantially acquired from the sagittal plane when the subject is standing; receiving a range of anteversion angles; receiving a range of inclination angles; determining a range of acetabular cup orientation angles for an acetabular cup implant for a subject based on the calculated spinopelvic metrics, received range of anteversion angles and the received range of inclination angles.
According to another example there is provided a computer-implemented method of determining a range of orientation angles for an acetabular cup implant for a subject, comprising: receiving a range of anteversion angles; receiving a range of inclination angles; receiving a spinopelvic metric of the subject; and determining a range of acetabular cup orientation angles for an acetabular cup implant for a subject.
It is acknowledged that the terms “comprise”, “comprises” and “comprising” may, under varying jurisdictions, be attributed with either an exclusive or an inclusive meaning. For the purpose of this specification, and unless otherwise noted, these terms are intended to have an inclusive meaning—i.e., they will be taken to mean an inclusion of the listed components which the use directly references, and possibly also of other non-specified components or elements.
Reference to any document in this specification does not constitute an admission that it is prior art, validly combinable with other documents or that it forms part of the common general knowledge.
The accompanying drawings which are incorporated in and constitute part of the specification, illustrate embodiments of the invention and, together with the general description of the invention given above, and the detailed description of embodiments given below, serve to explain the principles of the invention.
The methods described herein make use of patient-specific information to assess risks and determine optimal acetabular cup orientations for specific patients. The inventor has found that patient-specific spino-pelvic metrics are associated with the likelihood of a prospective arthroplasty recipient suffering negative outcomes such as a dislocation. The inventor has also found that patient-specific spino-pelvic metrics can place additional constraints on suitable installation orientations for acetabular cups in addition to universal (i.e. not patient-specific) orientation constraints that surgeons may otherwise work within. The additional patient-specific constraints may indicate a smaller range of particularly suitable acetabular cup orientations for the patient in question. The size of this smaller range may be another indicator of risk.
The spinopelvic metrics may be obtainable from one or more sagittal plane images of a standing patient. The term “sagittal plane” and the discussion of an image taken of the sagittal plane are not intended to require exact compliance with the nominal sagittal plane orientation or position on a subject. Due to variations in anatomy, imprecisions in a subject's posture during imaging and other factors this is rarely achievable. Instead, this terminology refers to images taken of a patient generally from the side of their body and image planes generally aligned with a plane passing through the anterior and posterior of a subject.
By assessing the risk to patients at an individual level, patients can be categorised by their risk level. This means that higher-risk patients can be provided with more comprehensive pre-operative imaging and analysis in preparation for surgery, whereas lower-risk patients would not need such extensive pre-operative procedures. This may decrease overall costs and improve efficiency and outcomes by directing resources to the patients most in need of them.
By taking into account patient-specific constraints on acetabular cup installation orientations, installation angles can be better tailored to individual patients. This may lead to improved surgical outcomes.
Based on the image, one or more spino-pelvic metrics is then calculated 12. Spino-pelvic metrics relate to geometric features of the skeletal structure including the spine, pelvis and femur. Spino-pelvic metrics can be indicators of a subject's kinematics and balance. The metrics can include, for example, lumbar lordosis (LL), pelvic incidence (PI), pelvic tilt (PT), sacral slope (SS), acetabulum ante-inclination (AI) and pelvic-femoral angle (PFA) as set out in the table below.
These metrics are illustrated in
The metrics can be measured based on anatomical landmarks. The landmarks can be identified based on user inputs. For example, a user can review the image on a computing device and place markers on the relevant landmarks. Alternatively, the landmarks may be automatically located using computer software. The computer software could include object recognition and labelling algorithms to identify landmarks and calculate the metrics. The computer software could be an artificial intelligence system. In one example, the artificial intelligence system is based on a machine learning model that has been trained on a data set related to the particular surgeon in order to learn that surgeon's preferences or techniques.
Combinations of these metrics can be used to construct other metrics for use in the risk assessment method 10. For example, sagittal balance is defined as PI−LL. As shown in
A hip arthroplasty risk characteristic of the subject is then calculated from the metrics 13. As noted above, the metrics may be used individually or in combination in determining the risk characteristic. A risk characteristic could take a range of values indicating a severity of risk or it could be a discrete risk categorisation such as “low risk” or “high risk”. The risk characteristic could be used on its own as a marker that the subject is at a certain risk of negative surgical outcomes. In one example, an instability metric is used to categorise a subject as high risk or low risk. The instability metric can be sagittal balance (PI−LL). In one example, risk categorisation is based on a subject having a value of PI−LL significantly greater than 0°, or greater than about 2°, or greater than about 10°. Subjects with PI−LL in these ranges can be categorised as being high risk. These subjects may be at an increased risk of suffering a dislocation after a hip arthroplasty. Another instability metric that could be used is ΔLL. The risk categorisation can be based on a subject having a value of ΔLL significantly lower than 40° or lower than about 29°. Subjects with ΔLL in these ranges can be categorised as high risk. Another metric that could be used is PFA. Very large or very small values of PFA could indicate risk due to the difficulty of installing an acetabular cup at a suitable orientation. For example, if post-operative combined sagittal index (CSI) is required to be within a certain range, it may be difficult to install an acetabular cup at an orientation that would result in a post-operative CSI within the required range when PFA is very large or very small. CSI is discussed in more detail with reference to
Alternatively or additionally, the metric can be used in combination with other data, such as anteversion and inclination angles, to determine a risk characteristic. The metric could be used as an input to a determination of certain arthroplasty parameters, such as a range of suitable acetabular cup orientation angles. This will be described in more detail with reference to
Before explaining the method of
Surgeons typically consider the coronal plane angles of anteversion and inclination when planning a hip arthroplasty. In particular, certain ranges of these angles are considered to be generally “safe” and at a low risk of negative outcomes (e.g. dislocation). However, surgeons may also exercise some judgement or personal preference for particular ranges of anteversion and inclination. However, some patients may still experience negative outcomes when acetabular cups are installed within these angle ranges due to the particular geometries of their skeletal structures. One measure of the likelihood of a patient to suffer negative outcomes is combined sagittal index (CSI). This is defined as the sum of PFA and acetabular cup ante-inclination, or CSI=PFA+AI(cup). The inventor has found that, for a given patient with a particular PFA value, some values of anteversion and inclination that might otherwise be considered “safe” in fact lead to a CSI value outside of an optimal range because anteversion and inclination are related to AI. Specifically, the inventor has determined that these are related as follows:
where α is cup inclination; β is cup anteversion; and γ is cup ante-inclination.
This relationship is depicted in the graphs of
In method 20 of
Based on the image, one or more spino-pelvic metrics are calculated 22. The metric(s) can be indicative of predicted instability of the subject post-surgery. One suitable metric for the method 20 is PFA. This may be particularly useful for placing a constraint on optimal acetabular cup installation angles.
The method 20 also includes receiving a range of anteversion angles 23. These angles may be predefined or based on the judgement or preference of a surgeon and may represent a range of anteversion angles considered to be suitable to install the acetabular cup in. In one example, the range may be centred around approximately 20°. In one example, a range of 20°±10° (i.e. 10° to 30°) is received.
The method also includes receiving a range of inclination angles 24. As with the anteversion angles, these may be predefined or based on a surgeon's judgement or preference. They represent a range of inclination angles considered to be suitable to install the acetabular cup in. In one example, the range may be centred around approximately 40°. In one example, a range of 40°±10° (i.e. 30° to 50°).
Based on the spino-pelvic metric(s), range of anteversion angles and range of inclination angles, a range of acetabular cup orientation angles is determined 25. In one example, the determined range of acetabular cup angles are angles at which the CSI of the subject would be within an acceptable CSI range if an acetabular cup were installed on that subject according to the received anteversion and inclination ranges. In one example, the acceptable CSI range is between 200°±10° and 245°±10° in a standing posture. The acceptable CSI range could be set based on empirical data, computer simulation/modelling or other research. The acceptable range could also be set based on a surgeon's skill level, preferences or judgement. The acceptable range could also be based on a level of risk tolerance or aversion. The subject's measured PFA can be used to define a range of AI(cup) values that will lead to a CSI within the acceptable range. The determined acetabular cup orientation angles can angles that are consistent with this defined range of AI(cup) values that lead to acceptable CSI values. Specifically, the AI ranges may be selected based on the equation:
CSI=PFA+ΔPFA+AI(cup)
where ΔPFA is the expected change in PFA following hip arthroplasty, such that CSI falls within the range of 200°±10°-245°±10°. ΔPFA can established clinically before surgery and typically lies within the range of 2°-10°. ΔPFA could also be given a fixed value such as 5°.
As can be seen from this relationship, the specific subject's value of PFA places a constraint on the optimal values of AI. When determining a suitable range of acetabular cup angles, the output angles can be those that meet this constraint as well as the received ranges of anteversion and inclination angles.
These figures show a shaded region 134 of inclination values that correspond to a received range of inclination values. This range is between a lower limit 135a and upper limit 135b. In this example, the range is between 30° and 50°. The shaded region 131 corresponds to a received range of anteversion angles. This range is between lower limit 132 and upper limit 132b. In this example, the range is between 5° and 25°. In
Also shown in
In
In some cases, the range of suitable angles of inclination and/or anteversion may be small based on the particular subject's spino-pelvic metrics. The size of either of these ranges may be used to determine a risk characteristic for the subject. For example, a subject for whom one or more of the ranges is small may be classified as higher risk than a subject for whom none of the ranges is small. In one example, if the determined range of either one or both of the ranges of acetabular cup inclination or anteversion is less than or equal to 10°, the subject is classified as high risk. In this example, if both ranges are greater than 10°, the subject may be classified as low risk. The size of ranges used to classify risk could be varied depending on factors such as particular surgeon's threshold for risk or taking into account other risk factors of the subject, for example. The characterisation of risk could also be proportional to the size of the ranges with multiple discrete, or a continuous scale of, risk characterisations.
Depending on the risk characterisation, the patient could be recommended for rigorous 3D planning in preparation for surgery. This may be only recommended for subjects characterised as high risk. This may involve generating 3D models of a patient's hip bones from CT or MRI scans. Alternatively, these may be reconstructed from coronal and sagittal plane X-ray data. During 3D planning, software may be used to calculate subject-specific anteversion and inclination ranges based on the patient-specific anteversion and inclination ranges calculated above; a combination of acetabular cup and stem anteversions; or a further optimised combination of anteversion and inclination angles that maximises hip range of motion. If the user customises the cup angle in the software, the software can provide warnings if the angles exceed any of the ranges above.
On the other hand, if a subject is characterised as low risk, they may be recommended for standard 2D templating.
The computing device can be any suitable computing device having one or more interfaces for receiving and outputting information, memory and processing circuitry. In one example, the computing device is a mobile phone. The computer implement method can be performed by such a computing device operating according to a set of instructions constituting a computer programme. The computer program could be in the form of a mobile phone application.
The computer program can include instructions for performing the procedures outlined above. In particular, it can implement the methods described with reference to
The risk classification 160 can be based on the procedures detailed previously. In particular, the surgeon's coronal cup angles 153 and the subject's sagittal measurements 156 are used are cross referenced using the nomograms 161 as detailed previously. A safe zone of acetabular cup angles is then determined 162 as the region that satisfies all of the constraints. The size of each of the ranges of determined acetabular cup angles (anteversion and inclination) are compared to a threshold value 163, in this case 10°. If both of the ranges are greater than 10°, the subject is classified as low risk 164. If one or both of the ranges is/are less than or equal to 10°, the subject is classified as high risk 165. Other threshold values may be used, for example 20°, 15° or 5°. The threshold value could be set based on empirical data, computer simulation/modelling or other research. The threshold value could also be set based on a surgeon's skill level, preferences or judgement. The threshold value could also be based on a level of risk tolerance or aversion.
While the present invention has been illustrated by the description of the embodiments thereof, and while the embodiments have been described in detail, it is not the intention of the Applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. Therefore, the invention in its broader aspects is not limited to the specific details, representative apparatus and method, and illustrative examples shown and described. Accordingly, departures may be made from such details without departure from the spirit or scope of the Applicant's general inventive concept.
Number | Date | Country | Kind |
---|---|---|---|
767569 | Sep 2020 | NZ | national |
This is a bypass continuation application of International PCT Application No. PCT/NZ2021/050155 filed on Aug. 30, 2021, which claims priority to New Zealand Patent Application No. 767569, filed on Sep. 4, 2020, which are incorporated by reference herein in their entirety.
Number | Date | Country | |
---|---|---|---|
Parent | PCT/NZ2021/050155 | Aug 2021 | US |
Child | 18117109 | US |