Computer Assisted Orthpaedic Surgery in Adult Reconstructive Surgery: Basic Concepts James B. Stiehl, MD Columbia St Mary’s Hospital Milwaukee, Wisconsin 1. Historical Landmarks a. Bargar and Paul, 1987, first robotic application i. IBM collaborative project ii. Developed digital “pixel” accuracy, 20-30 microns iii. Robodoc required preoperative CT, and fiducial placement b. DiGioia, Jarmaz i. Developed first CT total hip application in 1996 ii. Required CT segmentation protocol iii. Allowed intraoperative fiducial placement iv. Claimed accuracy of 1/1 mm c. Krakow; Saragaglia, 1997,1998 i. Separately developed total knee imageless referencing protocols ii. Required the development of hip/ankle kinematic referencing method iii. Validated precision on the order of 0.5 to 1 (Saragaglia,2007) 2. Components of Contemporary Computer Navigation Systems a. Computer platform i. Labtop or tower requires powerful processors and memory ii. Unix and Linnix codes preferred for stability with high digital processing, but Windows XP works if set up correctly iii. Open platform: allows use with any total knee prosthesis iv. Proprietary platform: limited by CAD models to one particular prosthesis v. Typical “capital” system: computer tower, CCD optical camera, LCD monitor, mouse, foot pedal activator. vi. Labtop System: Similar but with ‘suitcase’ portability. b. Tracking Technologies i. Optical: Requires Dynamic Reference Base with reflective balls (minimum 3; preferably 4-5) attached specifically to an array that is attached to the “target”. Target may be bone, instrument, prosthesis. Requires 2 or 3 optical cameras, that view passive or active (LED) arrays from distance of 6-8 feet. Must have unobstructed “line of sight”. Accurate to 0.25 mm. ii. Electromagnetic: Trackers emit electromagnetic impulse that is tracked by an electromagnetic coil, target must be within a box of 2030 centimeters. Does not require line of sight. Must have software algorithm that controls for ferrous, magnetic, or electrical interference to the electromagnetic impulse from the tracker. This is the current limiting factor for this technology! Accurate to 0.5 mm. iii. Ultrasound: Uses 2D, 2.5D or 3D probes to identify the position of a target landmark, bone, or object. Accurate to 0.25 mm. iv. Video Monitoring: Allows for realtime viewing of DRB movement. c. Referencing Methods: Means of Registering or Describing the “Target” i. Computed Tomography: Used initially for high 3D digital portrayal of the target object. First application was acetabular total hip placement. Requires segmentation of the image and standardization to a known reference frame, ie the anterior pelvic plane of the pelvis in THA. Highly reproducible and accurate to 1/1mm. Most systems utilize a ‘best fit’ validation scheme in the software. Currently requires a preop CT, but future systems with intraoperative CT may allow for ‘automatic’ registration. ii. Fluoroscopic Radiography: Two dimensional registration, that allows for biplanar images of the target object portrayed on screen, on which virtual movement of target objects such as drill or prosthesis may be observed by the surgeon. Requires registration of the images by direct ‘touch pointing’ of anatomical features that can be recognized on the images in real time. Similar accuracy as CT but relies on grid to correct for earth’s gravitational forces, and anatomical features that are specific enough to be precisely identified both on the patient and on the image. iii. Imageless: Requires direct ‘touch point’ matching of specifically predefined landmarks that are recognized by the computer software protocol. Example is the femoral center point in total knee application. One system defines this point as the center of the roof of the intercondylar notch which also is on Whiteside’s line, and the transepicondylar axis. Total knee is one of the applications that allows ready access to landmarks than can be referenced under direct vision. This method is accurate to 0.25 mm. iv. Kinematic: Novel method described for total knee where the femur is marked with a DRB, and then passed in a circular motion to define a cone shaped movement whose center is the center of the femoral head. The computer then identifies the finite projection of the cone which is the center of the femoral head. Similar method defines the transmalleolar axis of the ankle joint. v. Ultrasound: Uses 2D, 2.5D, 3D imaging of ultrasound to define points in space, to a submillimeter accuracy. Problem to date has been the inability to accurately describe broad anatomical surfaces such as the ASIS which lead to errors of 2-5 mm. vi. Bone Morphing: Secondary referencing method where surfaces of the target bone are described and overlayed onto a ‘baseline’ structure such as the distal femur. 3. Validation of Computer Systems: a. Descriptive terms of Standard Metrology i. Unit of Measurement: Value of measurable quantity ii. True Value: Value determined by perfect measurement, considered infinite, as infinite number of measurements needed to determine iii. Conventional True Value: Best guess measure, also ‘ground truth’ or reference value iv. Measurand: Quantity subject to measurement v. Influence Quantity: Sum of slight variance that may occur in measurement, such as identifying the exact edge of acetabular component vi. Accuracy of Measurement: Qualitative assessment of measured value in relation to the true value vii. Precision of Measurement: Closeness of agreement of independent test results obtained under stipulated conditions, such as repeatability or reproducibility, and usually defined as standard deviation. viii. Repeatability: Measurement under identical prescribed conditions ix. Reproducibility: Measurement when one condition is altered in measurement, such as having different observers. x. Error of Measurement: Result of measured value minus the true value of the measurand. xi. Random Error: Measurement of measurand minus the mean after infinite number of measurements. xii. Systematic Error: Mean measurement of measurand minus the true value after an infinite number of measurements. xiii. Random Error equals Error minus Systematic Error xiv. Systematic Error equals Error minus Random Error xv. Correction: Amount added to measured value to correct for systematic error. xvi. Type A Error: Deals with errors created by uncertainty xvii. Type B Error: Error other than statistical error. b. Descriptive Statistics: i. Mean ii. Standard Deviation iii. Experimental Standard Deviation 4. Process Capability Analysis a. After manufacturing process is brought under control assessment of precision or process capbability is done by following formula: Cp Cp (USL - LSL ) 6 b. Where USL and USL is upper and lower specification limits beyond which an outlier is determined. is standard deviation. c. Typical Cp for process capable function is 1.3 d. Where there is offset of measurand from true value, offset capability index is determined: Cpk (USL - x ) ( x - LSL ) Cpk min , 3 3 e. For this measurement, the minimum of either the first or second value is determined, with a goal of at least 2.0 f. This analysis basically determines the 6 or the bell shaped curve for a process, and defines outliers as anything below or above the bell shaped curve. General Electric states that an outlier, beyond the specification limits will occur in 3.4 of 1,000,000 trials. The advantage of this method is that it allows simple calculations that can be applied across a variety of technologies. g. The most difficult aspect of this method is to establish the upper or lower specification limits. 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