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Precision of Surface Measurements for Below-Knee Residua


Paul K. Commean, BEE, Kirk E. Smith, AAS, James M. Cheverud, PhD, Michael W. Vannier, MD
ABSTRACT. Commean PK, Smith KE, Cheverud JM, Vannier MW. Precision of surface measurements for below-knee residua. Arch Phys Med Rehabil 1996;77:477-86. Objective: To determine the absolute and relative precision of geometric measurements made of below knee (BK) residua and their BK plaster positive casts using calipers, electromagnetic digitizer, optical surface scanner (OSS), and spiral x-ray computed tomography (SXCT). Design: The experimental measurement protocol for a single measurement session was as follows: Dot markers were placed on the residuum, and volume and distances were measured using water displacement and calipers; residuum was measured using electromagnetic digitizer; residuum was scanned using threedimensional (3D) OSS; a negative plaster cast of subject's residuum was made; and residuum was scanned using SXCT scanner. These steps were repeated at a second measurement session. Plaster positive casts were constructed and subsequently measured using the same protocol. Participants: Thirteen adult below-knee amputee volunteers (subjects) participated in the study, and nine subjects returned for a second measurement session. The study group consisted of 9 men and 4 women; 10 Caucasians and 3 African Americans. Results: Distance measurements for all measurement devices were repeatable within 1% in vivo and within 0.5% on plaster casts; and volumes were within 1% in vivo and within 0.1% on plaster casts. Distance measurements for each device were precise within 3% in vivo and within 1% on plaster casts; and volumes were within 5% in vivo and within 6% on plaster casts when compared with caliper and water displacement measures. Conclusion: These measurement systems were found to be substantially equivalent in terms of repeatability and precision for measurement of lower extremity residua. level of life satisfaction. Nicholas and colleagues3 surveyed 94 amputee patients with 24% reporting dissatisfaction with the comfort of their prosthesis and 15% reported losing their jobs as a direct result of their amputation. A Canadian study4 reviewed employment patterns following amputation and found that 71.5% of the study subjects who did not take early retirement were employed postamputation. Subjects who wore their prosthesis were more likely to be employed. Chatterton5 surveyed 2,176 prosthesis users and found that patients were often intimidated by their prosthetist and were afraid to say the prosthesis did not fit well. These studies demonstrate the need for objective assessment methods to monitor and improve socket fit. Lower limb prosthesis quality of fit assessment is subjective in current clinical practice, based on subject reports of discomfort, local erythema or localized pain, and palpation. Wide variation in residual limb physical characteristics and condition preclude an inflexible approach to prosthesis prescription.6 With relatively long life expectancy for many who undergo lower limb amputations,7 outcome is measured in return to work and quality of life, which have important social and economic consequences. Many problems associated with prostheses are attributed to poor fit and may be correctable. The initial design and adjustment of prosthesis socket shape has traditionally been a manual process, with several research and commercial attempts to automate the socket design and fabrication process. T M The success of these efforts has been limited, and detailed evaluation at the socket-stump interface has been largely unavailable. Current computer-aided design/computer-aided manufacturing (CAD/ CAM) approaches to socket design help automate traditional plaster casting techniques, but are incapable of fit evaluation. Biomechanical properties of tissues and function have principally been studied in vitro because of lack of suitable instrumentation. An image-based method to evaluate in situ lower limb prostheses, focused on the socket/residuum interface and interrelationship to underlying supporting skeleton can aid in socket design, serve as a quality control method, and improve the assessment of residual limb function. Lunsford ~2 stated, "It is imperative that the O&P profession and industry develop and implement clinical assessments, as well as instruments, that are bias-free and capable of providing quantifiable measures of subject (consumer) benefits derived from use of the devices provided." When Faulkner and Walsh j3 investigated computed tomography (CT) scanning for prosthetics, they demonstrated the feasibility of incorporating CT data into a CAD/CAM package, performing modifications, and milling a plaster positive likeness. They also reported high image quality with CT and the benefit of seeing below the skin. However, they found significant movement artifact, high cost, and exposure to ionizing radiation. Therefore, they did not recommend CT scanning. We addressed these issues by using spiral x-ray computed tomography (SXCT), which enables volumetric imaging with reduced scan time compared to conventional "step and shoot" CT. SXCT was recently developed j4'15 and has been adopted for clinical body examinations in diagnostic radiology available in major medical centers. The spiral scanner is practical and advantageous because of improved image quality, minimal xray dose, and relatively low cost when compared with other

1996 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation
N ESTIMATED 400,000 persons with amputations live in the United States, with approximately 60,000 lower extremity amputations performed each year. I Many of these amputee patients are classified as "hard to fit." One US study2 found subjects rated comfort (52%) and function (38%) as the primary concerns when they wear a prosthesis. Sixty-seven percent of subjects wore their prosthesis 9 or more hours a day, and 57% reported moderate to severe pain while doing so. Respondents in the study with full- or part-time employment had a higher

From the MallinckrodtInstituteof Radiology(Mr. Commean,Mr. Smith,and Dr. Vannier),and the Departmentof Anatomyand Neurobiology(Dr. Cheverud), WashingtonUniversitySchoolof Medicine,St. Louis,MO. Submitted for publicationMay 11, 1995. Accepted in revised form October i3, 1995. Supported by the NationalInstitutesof Health/NationalCenter for Medical RehabilitationResearch grant RO1 HD30169. No commercialparty having a direct financialinterest in the results of the research supportingthis articlehas or will confer a benefitupon the authors or upon any organizationwith which the authors are associated. Reprintrequeststo MichaelW. Vannier,MD, MallinckrodtInstituteof Radiology, WashingtonUniversitySchoolof Medicine,510 SouthKingshighwayBoulevard, St. Louis,MO 63110. 1996bythe AmericanCongressof RehabilitationMedicineandthe American Academyof PhysicalMedicineand Rehabilitation 0003-9993/96/7705-351853.00/0

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methods for volumetric imaging, especially magnetic resonance methods. SXCT scanning of the extremities avoids exposure of reproductive organs and is considered a low-risk, noninvasive technique. The lower limb residuum soft tissue envelope is subject to both short- and long-term changes because of edema, venous pooling, exercise, weight gain/loss, muscle contraction, and atrophy. In addition, this soft tissue envelope has a heterogeneous composition and is continuously deformable. Even though lower extremity volumetry methods have been developed to quantify and help understand the effects of edema a n d atrophy, ~6-2~each of these methods is still limited in its assessment capabilities. We measured residua volumes with optical surface and SXCT volumetry.22 We found optical surface scanner volumetry gave quantifiable measurement results but is lirnited in its ability to assess prosthetic fit because of the lack of subsurface information. SXCT allows the socket-residuum interface to be seen simultaneously with the bone remnant location for visualization and measurement of the residuum with the prosthesis in situ, so soft tissue envelope change during fitting can be determined. Before SXCT and optical surface scanning could be used for measuring the shape of the residuum, we needed to know the precision and repeatability of these devices. Therefore, we tested the 3Space electromagnetic digitizer,a optical surface scanner (OSS), b and SXCT (Somatom Plus S) c on multiple subjects and plaster casts taken of their residua and compared these measurements to physical caliper measurements. We sought to answer 3 questions regarding the absolute and relative precision of measurements made directly on subjects and their casts in this study: (1) What is the precision and repeatability of the limb measurements using the various measuring devices? Are there differences in precision and repeatability among measurement methods? (2) Are there differences between measurements taken directly on subjects and comparable measurements taken on casts? (3) Are there differences between measurements made with the different devices?

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Fig 1. Line drawing of the surface scanning structure with camera (C) and projector (P) configuration. Camera 4 (C4) located directly in front of the residuum captures the distal end of the residuum. Three pairs of cameras (Cl-C3) and projectors (P1-P3) are located at the base and top of the structure.

METHODS Population
Thirteen below-knee adult amputee subjects were recruited and informed consent was obtained (as approved by our Institutional Review Board) to participate in our study. The study group consisted of 9 men and 4 women ranging in age from 31 years to 76 years (average age 49.15 years, median age 49). The first 9 of the 13 subjects were measured twice on two separate dates, or measurement sessions. The population of metropolitan SL Louis is predominantly Caucasian and Black. Therefore, we included only these two racial groups in our s t u d y - - 2 Caucasian women, 8 Caucasian men, 2 African American women and 1 African American man. Ten to 15 subjects are sufficient to identify major sources of error in a complex measurement protocol such as the one we used. 23

number of sensors chosen (four in this case) was based on the surface complexity, thus matching the system to the problem. The residuum OSS consists of 4 cameras and 3 projectors, which were affixed to a metal frame (fig 1) to capture an approximate 38cm cubic volume enveloping the subject's below-knee residuum. The instrument and its operation are similar to the medical human head scanner and are described in detail in previous publications23'25-28 and the head scanner had been proven to be accurate and repeatable in a previous study. 23

Computed Tomography
3D CT scanning of isolated human bones has been described and 3D reconstruction images have been shown to be accurate in osseous anthropometric applications.29 Subjects lie supine in the SXCT scanner with their residual limb held fully extended. We generated 3D reconstructions of the residual limb from an isotropic data volume synthesized from continuous 2D spiral CT slices (fig 2). Validation of distance and volume measurements from SXCT data of lower extremity residua were performed to determine the applicability of SXCT in prosthetic fitting.

Electromagnetic Digitizer
An electromagnetic digitizer has been used in our laboratory and proven to be accurate when measuring landmarks on human skulls29 and faces 23 as compared to caliper measurements. The digitizer consists of a hand-held wand that captures information with six degrees of freedom. The tip of the wand is placed onto a point and a pedal is pressed to digitize the point location on the subject who is seated in front of the digitizer with their residual limb held horizontally in space. We tested the digitizer's ability to capture the residuum soft tissue surface point locations as compared to the OSS, SXCT, and calipers.

Optical Surface Scanning


The OSS system used in this study employs a stationary multiple-sensor fixed geometry adapted from an optical human head scanner.24Four camera/projector sensors are configured to view the residual limb in extension with the subject seated or a horizontally oriented plaster cast surface (fig 1). By utilizing multiple sensors that digitize overlapping surface segments, 360 coverage is achieved. The multiple sensors allow flexibility in their positioning to cover the entire surface including the distal end not viewable by other optical scanning methods. The

Experimental Design
The experimental design is shown in figure 3 for one of two measurement sessions. At a single measurement session, the

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Fig 2. Volumetric SXCT slice data rendered as depiction of the below-knee skin surface along with several of the dot locations. The slices can also be viewed along either the short or long axis, allowing one to see the internal proximity of the femur, tibia, and fibula relative to the skin surface.

To determine the measurement locations for the below-knee residuum, the subject's residuum was positioned in a water bath and three proximal marks were placed on the residuum using a permanent marker at the water level to allow quick, repeatable, and simple volume measurements. The first dot was marked near or on the patellar tendon (dot 3 shown in fig 4), with two additional dots (dots 1 and 2 shown in fig 4) placed approximately 120 degrees on either side of the first, one medial and one lateral. After marking the three dots, the subject's leg was MeasurementObject Residua/Cast lowered into the water bucket until the dots intersected the water line. The water displaced by the subject's residuum was Caliper 3SpacerM/OSS/SXCT measured (the water bucket was sitting on a scale) using the MeasurementDevice Archimedes principle to determine its volume. We found the Archimedes principle of volume measurement to be more rapid (4 measurements could be taken within 1 minute or less), pre1 2 RepeatedScans cise, and repeatable than a water displacement measurement method where the water displaced was captured and measured. 1 2 1A IB 2A 2B RepeatedMeasurements After the subject removed his or her limb from the water bath, one additional marker (dot 6 shown in fig 4) was placed near Fig 3. Caliper and digitizer measurements are taken 2 and 4 times, rethe distal end of the tibia, and two additional markers (dots 4 spectively, since the fiducials (eg, dots) can be measured directly. For and 5 shown in fig 4) placed approximately 120 degrees on the OSS and SXCT scanners, repeat scanned images were measured either side of the distal end tibia marker, one medial and one twice to assist in isolating error resulting from the operator's choice of points and the measurement device. lateral.

subject's residuum (Measurement Object) was measured twice with each measurement device. The caliper~ measurements were taken twice and digitizer measurements were taken four times directly from the subject's residuum. The OSS and SXCT measurements could only be obtained from the scan data, so two scans each were taken using the OSS and SXCT scanner. For each scan, measurements were taken twice directly on the computer displayed image using software programs. At a later date, the subject returned for a second measurement session (the length of time between visits ranged from 1.5 to 4 months, with the average being 2.1 months). On enrolling a subject to participate in the study and obtaining informed consent, the following experimental protocol was used and measurements taken in the order described during a single measurement session: (1) Dots were placed on the residuum and the residuum was measured using water displacement and calipers; (2) the residuum was measured using a digitizer; (3) the residuum was scanned using 3D OSS; (4) a negative plaster cast was made of the subject's residuum; and (5) the residuum was scanned using the SXCT scanner. The steps in the protocol were repeated on each subject at a second measurement session.

The subject's plaster positive casts (one from each measurement session) were measured using the same protocol as performed on the subjects themselves (steps 1, 2, 3, and 5 were done). We evaluated the positive plaster casts as an independent standard to reduce the error associated with subject motion during scans. Each dot on the subject' s residuum was transferred to the negative cast when molded by the prosthetist and could be seen in the positive cast made from the negative cast. The plaster positives allowed us to eliminate variables associated with subject motion and soft tissue deformation, and represents the best possible precision when using precision digital calipers, digitizer, OSS, and SXCT scanner.
Below-Knee Residua Testing

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water transferable pencil. The negative cast was made with minimal application of pressure except in the patellar tendon region, which assisted in cast orientation during subsequent measurements. When the positive plaster cast was produced, the pencil marks and the sphere locations were visible. Subjects were transported to the SXCT scanner and scanned with radiographic CT markers in place. Subjects were placed on the scanner table foot/residuum first. Starting below the distal end of the residuum, approximately 256mm of the subject's residuum was scanned using 8mm/sec table feed over a continuous 32-second scan period. Scans were repeated to aid in error determination. The SXCT scanning parameters were collimation of 8mm, table feed of 8mm/sec, 120kVp, 210mAs, gantry tilt of 0, and maximum scan time of 32 seconds. The raw 3D image data were stored on an optical disk and processed on a Siemens CT satellite evaluation console,c The 3D voxel images were evaluated using ANALYZE31'32 software, f The 1.5ram sphere locations were identified and the distance between these points were measured using ANALYZE and the distances calculated. The plaster positive casts of the subjects were measured and scanned using the same procedure as described above. The cast was digitized or scanned twice using each measurement modality, without moving it, to ensure the two data sets were automatically superimposed. Statistical Methods Limb measurement precision and repeatability. Precision and repeatability is obtained from a nested analysis of variance (ANOVA) with scan nested within session, which in turn is nested within subject. The error term is due to the repeated measures of a single scan. Caliper measurements were only performed twice at each session, so the lowest level of the nested ANOVA (SCAN) is absent from the analysis. The model to address Question One (What is the precision and repeatability of the limb measurements using the various measuring devices? Are there differences in precision and repeatability among measurement methods?) is: Yijkl = # + ID~ + SESSIONj(IDi) + SCANk(SESSIONj(ID~)) + e0k~, where Y~juis measurement 1 of scan k (SCANk) taken at session j (SESSIONj) on subject i (IDa). The expected mean squares for each level are given by Sokal and Rohlf. 33Precision (measurement error) is evaluated in terms of standard deviations (precision of any one measurement device given in units of length or volume) and coefficients of variation (precision relative to the magnitude of the distance measured expressed in percent). The standard deviations measure the square root of the average squared difference between classes within a factor. Repeatability (precision of the measurement relative to the difference between subjects being measured) is the proportion of the total variation which occurs between subjects, differences among repeated measurements within subjects typically being considered as measurement error. Subject versus cast measurements. Question Two (Are there differences between measurements taken directly on subjects and comparable measurements taken on casts?) has two aspects. First, is there a bias in measurements made on casts, such as, are they typically smaller or larger than measurements taken directly on subjects? This was tested by an ANOVA with cast as the factor. Separate analyses were performed for each measuring device. Second, even when there is no bias, it is possible that the casting process results in considerable random error, the cast being larger or smaller than the subject depending on which subject is examined. These aspects to Question Two were analyzed by a nested ANOVA with the cast factor nested within session and then further nested within subject: Y~jk~= /Z

Fig 4. Anterior view of a right below-knee amputee. The dot locations were not placed on bony landmarks because of the hardware design of the OSS and the water volume measurement method. The OSS required dots 3 and 6 to be placed along the anterior face of the tibia, and four additional dots were placed at 120-degree increments (medial and lateral) because the OSS cameras were located at 120-degree intervals about the scanner structure. Dot 3 was placed near or on the patellar tendon.

Distance measurements were repeated twice, using calipers, between the various pairwise combinations of the six marker centers located on the subject. The repeated measurements produced two distance measurement sets of 15 measurements each. The digitizer was used to digitize each marker location once and was repeated a total of four times. The 3D coordinates from the digitizer were saved into a file and the distance measurements automatically calculated. The repeated measurements of the marker locations on the residuum were required to estimate the measurement error introduced by the operator. This measurement process was repeated for each plaster positive. After measuring the residuum using the calipers and digitizer, .635cm black colored dots were applied to the permanent marker locations for making measurements with the 3D optical surface scanner. Subjects were scanned twice using the prosthetic 3D optical surface scanner. The 3D surface data for each of the two scans were processed and rendered on a Silicon Graphics, Inc., 4D/340 VGX graphics workstatione to determine if movement had occurred and to verify that all six dots had been captured. The surface data was read, displayed as a cylindrically unwrapped image, and measured using a program written with the PV-Wave3 command language. Measurements were performed twice to determine error introduced during dot digitization for each surface data set. On completion of the surface scans, conventional radiography/CT markers containing 1.5-mm diameter lead spheres were centered on the colored .635cm dots so measurements could be taken between them. The prosthetist then placed a thin sock on the subject and marked the sphere locations on the sock with a

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BELOW-KNEE RESIDUA MEASUREMENTS, Commean Table 1: Error Standard Deviation for Error Resulting From Repeat Measurements of a Single Scan and Error Resulting From Repeat Scans Combined (for Subjects)
Error Standard Deviation (SD) (mm) DIG Distances Maximum Minimum Median Average SD Volume SD (cc) 1.94 .78 1.31 1.34 N/A OSS 3.11 .75 1,62 1.79 32.44 SXCT 1.53 .59 .86 .88 8.66 PHY 1.06 ,41 .83 .74 11.22 DIG 1.92 .54 1.01 1.14 N/A Coefficient of Variation (%) OSS 2.96 .69 1.52 1.50 2.67 SXCT 1.30 .48 .62 .75 ,71

481

PHY 1.05 .46 .58 .61 .92

+ 1D~ + SESSIONj(ID~) + CSk(SESSIONj(ID0) + eijkl, where Y~jk~is measurement 1 of cast or subject k (CSk) taken at session j on subject i. We will consider the standard deviation due to differences between cast or subject (CS) as a measure of the average difference between casts and the subjects they represent. Modality differences. Both bias and random error contribute to measurement differences obtained by different methods. For sake of convention, the caliper measurements will be taken as the standard and measurements based on other devices compared to them. Bias will be analyzed by an A N O V A with measurement type as the factor. Random error is measured with a nested A N O V A model to address Question Three (Are there differences between measurements made with the different devices?): Yijkl: ~ + IDi q- SESSIONj(IDi) + TYPEk(SESSIONj(IDi)) + eijk~, where y~jk~is measurement 1 of measurement modality k (TYPEk) taken at session j on subject i. We will consider the standard deviation due to type (TYPE) as a measure of the average difference between measurements taken with calipers and those taken by the device specified. Each device is compared to caliper measurements separately. The analysis is also performed separately for direct subject measurements and those taken on casts. RESULTS

Limb Measurement Precision and Repeatability


In terms of precision or measurement error, it is also instructive to consider the magnitude of error between and within repeated scans. The error standard deviation for error caused by repeat measurements of a single scan and error caused by repeat scans combined is typically between 1.3 and 1.Smm for direct subject measurements taken with the digitizer or OSS and between 0.7 and 0.9mm for direct measurements with calipers or with SXCT (table 1). The associated coefficients of variation are between 1.1% and 1.5% and between 0.6% and .75% of the mean values, respectively. Measurements of the casts can be made even more accurately with standard deviations of only 0.3mm for caliper and digitizer measurements and 0.6ram for OSS and SXCT measurements. Therefore, these devices, on average, can repeat measurements to within 0.7 to 1.8mm when made directly on subjects and to within 0.3 to 0.6mm when made on casts (table 2). Error in limb volumes

was approximately 5 to 10cc (0.5% to 1% of the mean value) except for direct subject measurements taken on subjects with the optical surface scanner, which had a standard deviation of 32cc, representing 2.6% of the mean value. We can compare the error variances caused by the various measurement devices to determine whether one is significantly better than another in its precision when used to measure residua. This is done using a ratio of their error variances and testing for statistical significance with an F ratio. Error includes that caused by scan and repeat measurement within scan. In comparing caliper measurements with those obtained by other means, there were 22 degrees of freedom for caliper measurements and there were 66 degrees of freedom for the other modafities. Repeatability for linear dimensions was low for all measurement methods because of the relatively large variation between measurements taken at different sessions. For all measurement devices and for both direct measurements made on subjects and casts, approximately 70% of the variation is between subjects, as can be seen in the wide variation in shape and size of the various subjects scanned with the SXCT (fig 5), 30% between sessions, and a very small percentage between scans and between measurements of a single scan (table 3). Even though the percentage was small, most of the between-scan variances for all modalities were significantly greater than zero for direct subject measurements. Repeatability for limb volume was very high, typically around 93% with only 7% between sessions (table 4). None of the error variances within sessions accounted for more than 1% of the total for any measurement. Standard deviations due to measurement sessions were approximately 10mm for linear distances and 100cc for volume with coefficients of variation (COV) at 8% of the mean for distances and 8% to 13% of the mean for volumes (table 5). For direct linear measurements made on subjects, calipers are more repeatable than measurements taken with the digitizer or the OSS (significantly less error for caliper measurements in 12 and 14 of 15 cases, respectively). However, caliper measurements are significantly more repeatable than spiral C T - b a s e d data for only 5 of 15 linear dimensions. SXCT measurements are significantly more repeatable in 10 out of 15 measurements compared to the digitizer and for 13 of 15 measurements compared to the OSS. Finally, the digitizer has significantly less error than the OSS for 8 of the 15 measurements, the reverse holding mae for a single measurement. For measurements of volume, both water

Table 2: Error Standard Deviation for Error Resulting From Repeat Measurements of a Single Scan and Error Resulting From Repeat Scans Combined (for Casts)
Casts' Error Standard Deviation (ram) DIG OSS .94 .36 .55 .58 7.03 SXCT .74 .41 .60 .57 7.23 PHY .33 .15 .21 .22 4.15 DIG .37 .15 .23 .25 N/A Casts' Coefficient of Variation (%) OSS .75 .32 .40 .49 .58 SXCT .81 .32 .44 .48 ,60 PHY .31 .09 .19 .19 .34

Distances
Maximum Minimum Median Average SD Volume SD (cc) .43 .20 ,30 ,30 N/A

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Fig 5. Volumetric SXCT rendering of skin surface of 12 belowknee amputee patients. The skin surface is depicted with the fiducial marker locations used for comparative measurement analysis. Volumes were computed by delimiting the data set with a plane passing through three proximal fiducials.

displacement and SXCT measures are significantly more repeatable than OSS measurements, but they are not significantly different from one another. In summary, caliper measurements are the most repeatable, followed closely by SXCT measurements, then digitizer measurements, and, finally, OSS measurements. For measurements taken on casts, the relative repeatability is different. Caliper measurements still have the highest repeatability, but digitizer measurements are only slightly less repeatable. SXCT and OSS repeatability is indistinguishable and in

each case is significantly less than caliper or digitizer measurements. For measures of cast volume, both SXCT and OSS measures are less repeatable than water displacement but are not significantly different from each other. For all measurement methods, repeatability of measurements on casts was significantly better than for direct measurements on subjects (table 6). However, this was only marginally true for measurements taken with SXCT. Although this may indicate a preference for measuring casts rather than taking direct subject

Table 3: Average Repeatabilities of the 15 Linear Distances From Residua Measurements


DIG Subjects Individuals Sessions Scans Direct Error Total Variance Casts Individuals Sessions Scans Direct Error Total Variance 70.89 28.24 .28 .59 289.67 70.10 29.87 .01 .02 335.17 OSS 68.58 30.25 .88 .29 302.14 69.16 30.72 .03 .09 327.36 SXCT 68,58 31.12 .18 .12 311.55 69.47 30.42 .03 .09 333.13 PHY 66.63 33.15 N/A .22 301.28 69.46 30.52 N/A .02 326.56 Units % % % % mm 2 % % % % mm 2

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Table 4: Residua Volume Repeatabilities for OSS, SXCT, and PHY


OSS Subjects Individuals Sessions Scans Direct Error Total Variance Casts Individuals Sessions Scans Direct Error Total Variance 93.135 6.17 .67 .625 151,554 83.40 16.56 .00 .04 157,897 SXCT 92.975 6.98 ,00 .045 155,438 93.25 6,72 .00 ,03 186,764 PHY 94.82 5.10 N/A .08 159,924 94.45 5.54 N/A .01 179,607 Units % % % % cc 2 % % % % cc 2

measurements, it must also be considered that casts may be imperfect representations of the limb stumps themselves.

Measurements taken directly on subjects have random differences from caliper measurements of approximately 2.0mm (1.6% of the mean) for digitizer and OSS, and 3.5mm (3.0% of the mean) for SXCT (table 8). Casts show much smaller random deviations of approximately .75mm (0.6% of the mean) differences from the caliper measurements for all three alternate measurement methods (table 9). Cast measurements taken using digitizer, OSS, and SXCT are almost always more similar to caliper measurements than measurements made directly on the subject. When deviations from caliper measures were compared, there were 18 degrees of freedom for caliper measurements. The digitizer and OSS show a similar degree of random deviation from caliper measurements; however, each is often significantly closer to the caliper measurements (8 of 15 linear measurements for the digitizer and 13 of 15 linear measurements for OSS) than are the SXCT measures. DISCUSSION

Subject Versus Cast Differences


There was no significant bias of casts relative to subjects in the caliper measurements. Only two measures were significantly larger in casts when measured with the digitizer, measurement number 7 was on average 3.43mm longer and measurement number 8 was 2.48mm longer on average. Measurement number 10 was 3.22mm shorter, on average, for measurements of casts taken with OSS. For SXCT measures, measurement number 4 is 3.72turn shorter, measurement number 5 is 2.21mm longer, measurement number 11 is 3.40mm longer, measurement number 14 is 4.30mm shorter, and measurement number 15 is 3.50mm longer on casts than on subjects. Given the one statistically significant bias expected by chance and the lack of consistency in the results in terms of the direction of bias, it appears that there is no serious bias toward measurements being larger or smaller when taken from subjects than when taken from casts. No bias among the measurement methods was detected between volume of casts or subjects. Random error was statistically significant in all cases. Differences between direct measurements and measurements on casts were approximately 3.75mm or 3.3% of the mean for caliper, digitizer, and OSS measurements. Differences were greater for SXCT measures, approximately 4.90mm, or 4.3% of the mean. Volume measures differed by 54cc (4.4% of mean), 72cc (6% of mean) and 47cc (4.3% of mean) for water displacement, OSS, and SXCT, respectively (table 7).

Limb Measurement Precision and Repeatability


Measurements taken at any one session were remarkably repeatable, differing only about l m m or 1% on average of the mean values for measurements taken directly on subjects and only about .25 to .50mm for measurements taken on casts. Even though error was small for all devices, it was least for caliper measurements. Measurements taken directly on subjects from SXCT scans were nearly as repeatable as caliper measurements, whereas digitizer and OSS measurements were less repeatable. For measurements taken on casts, digitizer measures were nearly as repeatable as those taken by calipers, whereas SXCT and OSS measures were slightly less repeatable. Casts were measured with greater repeatability than direct measures on subjects with all devices, although this difference was much reduced for SXCT measurements. With the protocol used here, measures of limb stumps cannot be very reliably measured at different sessions using any of the measurement devices directly on subjects or on casts. On average, linear measurements differ by about 10mm or 8% of the mean. Approximately 30% of the variance may be caused by error in repeatedly placing the dots near the same position on the residuum from one subject visit (measurement session) to the next visit. This error may also be caused by the subject's residuum changing size between sessions (the length of time between visit ranged from 1.5 to 4 months with the average being 2.1 months). Eight of the nine subjects who participated in two measurement sessions wore permanent prostheses. The optical surface scanner design dictated the placement of the dots at 120-degree intervals about the subject's residuum because the OSS sensors were placed at 120-degree intervals about the structure. Also, it was necessary to mark the patellar tendon dot while the residuum was immersed in the water bath, which made it difficult to identify the patellar tendon or the tibial
Table 6: Ratios of Error Standard Deviations for Subjects Relative to Casts
Standard Deviation of Scan + Direct Measurement Error (ram) DIG Distances Maximum Minimum Median Average SD Volume SD (cc) 8.02 1.82 4.57 4.76 N/A OSS 5.58 1.49 2.55 3.20 4.62 SXCT 2.26 1.06 1.45 1.56 1.20 PHY 5.96 1.95 3.10 3.40 2.70

Modality Differences
No bias was detected in either direct subject measurements or cast measurements for any of the measurement types relative to caliper measurements.
Table 5: Standard Deviations (Precision) and Coefficients of Variation (COV) (Precision Relative to Length or Volume) for Measurement Sessions
DIG Average SD of distances (mm) Subjects 8.85 Casts 9.63 SD of volumes (cc) Subjects N/A Casts N/A Average COV for distances (%) Subjects 7.64 Casts 8.17 COV for volumes (%) Subjects N/A Casts N/A OSS 9.40 9.69 96.71 161.72 8.17 8.18 7.97 13.32 SXCT 9.47 9.65 104.14 112.01 8.14 8.08 9.23 8.57 PHY 9.80 9.61 90.33 99.76 8.10 8.40 8.10 7.44

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Table 7: Comparison of Distance Measurements on Subjects and Casts


Standard Deviation (ram) DIG Distances Maximum Minimum Median Average SD Volume SD (cc) 5.56 2.60 3.65 3.90 N/A OSS 6.48 2.40 3.76 3.68 72.17 SXCT 8.76 3.16 4.03 4.90 47.42 PHY 12.00 2.16 3.33 3.87 53.85 DIG 7.64 2.19 3.04 3.34 N/A Coefficient of Variation (%) OSS 8.90 1.88 2.66 3.39 5.94 SXCT 12.03 2.42 3.70 4.30 3.91 PHY 7.76 1.50 2.71 3.32 4.44 Mean Distances (mm) 166.8 72.8 119.3 122.7 1214.0

tuberosity. Therefore, all six dots were not placed on bony landmark locations, so repeatedly and precisely finding the six dot locations from one visit (session) to another was not possible. If measurement error between sessions is important in fitting prostheses, using bony landmarks would aid in more accurately locating dots from one session to the next. In our original conceptualized experimental protocol, we thought that finding bony landmarks on the BK residuum would be used for making measurements, but due to the OSS design and water displacement measurements, we were unable to use bony landmark locations. Therefore, we anticipated that finding the same dot placement locations from one session to the next session would be difficult and our results indicate this fact.

Subject Versus Cast Differences


There are only occasional small biases in measures made on casts relative to those made on subjects. However, there is random error introduced by casting, on the order of 4mm. Although casts can be measured more repeatably, their random deviation from the subject is greater than the gain in accuracy obtained in measuring them. The random deviation may be caused by two variables: (1) two different prosthetists performed the castings on different subjects, and (2) when the dot locations transferred from the subject's residuum to the negative cast, their location was not always easy to identify in the positive plaster cast. Placement of a blue pencil mark on the thin sock worn by the subject over each dot to indicate their locations before the negative plastering process did not always remedy the identification problem. In fact, in a number of cases the blue marks would be shifted up to approximately 10mm from the impression left by the lead sphere markers. Also, the two prosthetists did not make negative casts of the same individual to determine if there was a difference in their casting methods.

divergent from the caliper measures. On further analysis of the SXCT data, we found that because the subject's residuum was lying relaxed on the SXCT table (instead of being tensed while suspended in air as when the caliper, digitizer, and OSS measurements were taken) the shape of the residuum had changed, causing 12 of the 15 measurements to be much more divergent than the remaining three measurements (SXCT Measurement Number 3, 8, and 12 values were 2.37mm, 3.28mm, and 1.46mm, respectively, and can be compared to the values in table 8) for all subjects. These three measurements had similar random errors on the order of 2mm when compared to the calipers, digitizer, and OSS. These three measurements were between dots 1 to 4, 2 to 5, and 3 to 6, which were longitudinal measurements (proximal to distal) and would have the least amount of change when a subject's residuum was lying relaxed on the table as compared to the other 12 measurements.

General Discussion
The precision and repeatability error of the digitizer, OSS, and SXCT being greater on subjects as compared to the plaster casts may be attributed to several variables observed during the experimental protocol. First, while making measurements with the calipers, OSS, and digitizer, the subject's residuum was not rigidly fixed in position, allowing the subject's leg to move while measurements were taken; and for the individual taking the measurements with calipers and digitizer, no hand/arm rest was available, which allowed their hands/measurement device to move slightly while taking measurements. For casts, the measurement device could be held firmly against the cast dot location, unlike with the subjects, where steadying the measurement device against the dot would cause the subject's skin surface to deform. Second, a single measurement session would last from 3 to 5 hours. During this time period, the subject' s prosthesis would be removed for the entire time period. Several subjects indicated that at the beginning of the session they had swelling problems. So we repeatedly measured the volume of their residuum at different times during the session. We found that on these subjects the volume measurements changed from approximately 5% up to 15% over the course of the measurement session. Therefore, the order in which the measuring devices were used to measure the subject's residuum could be important. For practical logistical reasons, especially access to the SXCT
Table 9: Comparison of Caliper Measurements of Casts to Other Measurement Types
Casts' Standard Deviations (mm) DIG Distances Maximum Minimum Median Average SD Volume SD (cc) 1.33 A1 .68 .71 N/A OSS 1.46 .53 .78 .81 70.23 SXCT 1.46 .15 .55 .66 17.44 Casts' Coefficient of Variation (%) DIG 1.23 .09 .52 .62 N/A OSS 1.01 .34 .59 .68 5.79 SXCT 1.25 .18 .46 .53 1.44

Modality Differences
There is no bias in measurements taken with the different devices used in this study. However, there is statistically significant random error in that particular digitizer, OSS, and SXCT measurements may be larger or smaller than the caliper measurements. These deviations from the caliper measurements are on the order of 2.0 to 3.5mm. The SXCT measures are most
Table 8: Comparison of Caliper Measurements of Subjects to Other Measurement Types
Subjects' Standard Deviations (mm) DIG Distances Maximum Minimum Median Average SD Volume SD (cc) 3.21 .70 2.31 2.11 N/A OSS 2.60 .43 1.85 1.86 59.90 SXCT 5.38 1.46 3.73 3.48 58.76 Subjects' Coefficient of Variation (%) DIG 2.69 .72 1.93 1.77 N/A OSS 2,17 .41 1.63 1.56 4.93 SXCT 6.27 1.39 2.61 3.02 4.84

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scanner (a very busy instrument located in Barnes Hospital, St. Louis, MO, which is approximately 1500ft. from the OSS and digitizer), we used nonrandom ordering of scanning tests. We had no workable alternative that would allow us to randomly order the tests and complete the protocol. Also, if there was a test order bias, it was consistent from subject to subject. Swelling may have caused the measurements to be affected due to the change in the subject's residuum volume. The plaster casting process was performed after the subject's prosthesis had been removed for 1 to 2 hours, which may also partially account for the differences in the casts versus subjects. The S X C T scans were taken approximately 2.5 to 4.5 hours from the start of the session. Because no bias was detected in the S X C T data, it would appear that no swelling had occurred, but it also must be remembered that the residuum had changed shape during the S X C T scan, which could aid in masking a bias. For example, let us assume the residuum to be cylindrical in shape, using the average mean distance (122.73mm) from table 7 for both the cylinder's height and diameter, with the height being constant and the diameter varying, a 2-mm diameter increase taken from table 8 (1.6% increase in distance) would result in approximately a 3% increase in volume size (48cc), and a 3.5-mm diameter increase taken from table 8 (2.9% increase in distance) would result in an approximate increase of 6% in volume size (83cc), similar to the average volume shown in table 8. So even a small amount of swelling (5% or less) from the beginning to the end of a measurement session on all subjects could easily have caused the caliper measurements to be different from the digitizer, OSS, and SXCT. If the distance and volume measurements were taken on all the subjects at the end of the measurement session, this assumption could have been proven. Practically speaking, it appears that any of the measurement methods is more precise than the changes in residuum size that occur both during and between sessions, and due to subject's relaxation. Accordingly, prosthetic fit (and comfort) is unlikely to be affected by measurement methods, ie, all are likely to be equally good in practice. Ten millimeters of uncertainty in measures is far larger than the calibrated precision of any of the measuring instruments, and also seems to indicate that several measurements and adjustments may often be necessary before a prosthesis exhibits good fit. CONCLUSION We tested the ability of an optical surface scanner (OSS) and spiral x-ray CT scanner (SXCT) to precisely and repeatably measure residua in below-knee volunteers. The results demonstrate that the digitizer, OSS, and S X C T precision and repeatability are sufficient for quantitative studies. W e compared distance measurements from calipers with the digitizer, OSS, and 3D S X C T scanner measurements and found substantial equivalence of these methods. As indicated by Rubin and associates, 6 the residual limb physical characteristics vary widely, as shown in figure 5, making a rigid approach to prosthetic fitting impractical. OSS and S X C T will not only allow the prosthetist to see the wide variation in skin surface geometry, but S X C T allows the prosthetist to see the internal structure of the residuum. The tibial and fibular geometry along with their proximity to the skin surface will aid in overcoming blind fitting (not knowing what is located and how far the bone is located beneath the skin surface) by the prosthetist, and improve the custom fitting process with S X C T ' s ability to capture internal 3D morphology. Acknowledgments: The original design concept of the Cencit, Inc., head optical surface scanning system is credited to Dr. John Grindon. This work was supported by the National Institutes of Health/National

Center for Medical Rehabilitation Research grant RO1 HD30169. We wish to thank Universal Vision Partners, owners of the Cencit technology, for their support. The ANALYZE software system was provided by Dr. Richard Robb and Dennis Hanson of the Mayo Biomedical Imaging Resource in Rochester, MN. We appreciate the cooperation of James Weber, President, Gil Christley, CPO, and Marsha Klunk, CPO, of the Orthotic and Prosthetic Laboratories, Inc. (St. Louis, MO) for expert advice, referral of subjects, and for performing the plaster casting.
References

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Suppliers
a. Kaiser Aerospace and Electronics Co., PO Box 560, Colchester, VT 05446. b. Cencit, Inc., St. Louis, MO (out of business). c. Siemens Medical System, Inc., 186 Wood Ave. South, Iselin, NJ 08830-2770. d. Digimatic Calipers: Model CD-18 Series 500-505-50; + / - 0.001"; Mitutoyo Corporation, 31-19, Shiba 5-chrome, Minato-ku, Tokyo 108, Japan. e. Silicon Graphics, Inc., 2011 North Shoreline Blvd., Mountain View, CA 94039-7311. f. Mayo Foundation, Biomedical Imaging Resource, Rochester, MN 55905.

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