Abstract
The angle of acetabular inclination is an important measurement in total hip replacement (THR) procedures. Determining the acetabular component orientation intra-operatively remains a challenge. An increasing number of innovators have described techniques and devices to achieve it. This paper describes a mechanical inclinometer design to measure intra-operative acetabular cup inclination. Then, the mechanical device is tested to determine its accuracy. The aim was to design an inclinometer to measure inclination without existing instrumentation modification. The device was designed to meet the following criteria: 1. measure inclination with acceptable accuracy (+/− 5o); 2. easy to use intra-operatively (handling & visualization); 3. adaptable and useable with majority of instrumentation kits without modification; 4. sterilizable by all methods; 5. robust/reusable.
The prototype device was drafted by computer aided design (CAD) software. Then a prototype was constructed using a 3D printer to establish the final format. The final device was CNC machined from SAE 304 stainless steel. The design uses an eccentrically weighted flywheel mounted on two W16002-2RS ball bearings pressed into symmetrical housing components. The weighted wheel is engraved with calibrated markings relative to its mass centre. Device functioning is dependent on gravity maintaining the weighted wheel in a fixed orientation while the housing can adapt to the calibration allowing for determining the corresponding measurement. The prototype device accuracy was compared to a digital device. A digital protractor was used to create an angle. The mechanical inclinometer (user blinded to digital reading) was used to determine the angle and compared to the digital reading.
The accuracy of the device compared to the standard freehand technique was assessed using a saw bone pelvis fixed in a lateral decubitus position. 18 surgeons (6 expert, 6 intermediate, 6 novice) were asked to place an uncemented acetabular cup in a saw bone pelvis to a target of 40 degrees. First freehand then using the inclinometer. The inclination was determined using a custom-built inertial measurement unit with the user blinded to the result. Comparison between the mechanical and digital devices showed that the mechanical device had an average error of −0.2, a standard deviation of 1.5, and range −3.3 to 2.6. The average root mean square error was 1.1 with a standard deviation of 0.9. Comparison of the inclinometer to the freehand technique showed that with the freehand component placement 50% of the surgeons were outside the acceptable range of 35–45 degrees. The use of the inclinometer resulted all participants to achieve placement within the acceptable range. It was noted that expert surgeons were more accurate at achieving the target inclination when compared to less experienced surgeons.
This work demonstrates that the design and initial testing of a mechanical inclinometer is suitable for use in determining the acetabular cup inclination in THR. Experimental testing showed that the device is accurate to within acceptable limits and reliably improved the accuracy of uncemented cup implantation in all surgeons.
