Our study consisted of two parts. In the first part of the study, we determined the relationship between magnification of a reference object placed on top of the pubic symphysis and magnification of the hip on AP pelvic radiographs. In the second part we determined which of three methods (one analog hard-copy templating method and two digital templating methods) was the most accurate templating method and if the methods were reproducible. We made these assessments for cemented and uncemented prostheses.
To determine the relationship between magnifications of the hip and the reference object, we initially included 56 patients in a retrospective analysis. We included patients in whom THA was performed by or under the supervision of one of the authors (JBAvM) from December 2005 to August 2006, with a prosthetic head diameter of 28 mm, a postsurgery AP pelvic radiograph with a reference object at the pubis symphysis, and a known prosthesis head size. Six of the 56 patients were excluded because the implanted prosthesis was a Metasul® (Zimmer, Ltd, Swindon, UK) THA. The metal-on-metal construction of this type makes it impossible to obtain adequate measurement of the diameter of the prosthetic head on a radiograph. The patient group then consisted of 50 patients (36 females, 14 males) between 49 and 87 years of age.
Because the reference object and the hip usually are not at the same distance from the detector, scaling one-to-one using a reference object is incorrect unless a correction factor is used. To determine the relationship between magnification of the hip and magnification of the reference object placed on the pubic symphysis, we measured the diameters of the prosthetic head and the reference object on the postsurgery digital AP pelvic radiographs with Agfa Web1000™ software (Agfa Healthcare, Mortsel, Belgium). The measured diameters were divided by the object’s real diameter (10 mm for the reference object, 28 mm for the prosthetic head) to determine the magnification and the results recorded.
The relationship between magnification of the hip and reference object was estimated with a linear fit performed in SPSS® for Windows® (SPSS Inc, Chicago, IL). Correlation/regression analysis was performed with the linear regression function in the same program. Correlation strength and significance were calculated and determined according to Cohen [5] (small, 0.10 < R < 0.29; medium, 0.30 < R < 0.49; large, 0.49 < R < 1.00).
To compare and determine the most accurate templating method, we retrospectively identified 33 patients between 50 and 83 years of age. The study group consisted of 16 uncemented THAs (10 females, six males) and 17 cemented THAs (14 females, three males). We included patients in whom THA was performed by or under the supervision of one of the authors (JBAvM) from December 2005 to October 2006, with a presurgery AP pelvic radiograph with a reference object at the pubic symphysis and a known prosthesis size.
The AP pelvic radiographs were generated with a 100-cm source-detector distance, the patient in the supine position, and focus on the patient’s midline, the pelvis, and as much of the femur as possible included. The digital radiograph was stored in the hospital’s Picture Archiving and Communications System and printed for use in analog hard-copy templating. The reference object was a massive metal sphere with a diameter of 10 mm and was positioned at the pubic symphysis of the patient. For a cemented prosthesis, the M.E. MüllerTM Straight Stem (Zimmer, Ltd; standard or lateral; five sizes, 7.5–17.5) was used in combination with a MüllerTM Low Profile Cup (Zimmer, Ltd; 13 sizes, 40–64). For an uncemented prosthesis, the CLS® SpotornoTM Stem (Zimmer, Ltd; CCD angle, 135° or 145°; 11 sizes, 6–17.5) was used in combination with the Fitmore™ Shell with stabilization fins with a Fitec polyethylene insert (Zimmer, Ltd; 13 sizes, 40–64). The largest possible prosthesis was chosen within the cortical edges of the femur and the acetabulum.
Analog hard-copy templating was performed using transparent sheets on which the contours of the prosthesis were depicted. The magnification of the templates is 15% as provided by the prostheses manufacturer (Zimmer, Ltd). The hard-copy radiograph was overlaid with the template and the prosthesis sizes were determined for femoral and acetabular components. All surgeries were preceded by preoperative templating according to the analog hard-copy templating method.
Digital Method 1 was performed with IMPAX™ ES Orthopaedic Application planning software (Agfa Healthcare). Preliminary to digital templating, we determined magnification of the hip by ascertaining the magnification of the reference object. First, a circle was positioned (integrated in the software) indicating the edges of the reference object. Next, the diameter of the reference object was given and the radiograph was automatically scaled to the magnification of the templates (also integrated in the software). Templating was performed and the implant sizes recorded.
Digital Method 2 was performed identical to Digital Method 1 except for scaling of the radiograph. Instead of using the diameter of the reference object, the diameter of the reference object was measured on the radiograph and used for correction for the difference in object-detector distance between patients by using the linear relationship between magnification of the reference object and the hip (found in Part 1 of the study). The corrected reference object diameter was used as the input when scaling the radiograph to the magnification of the templates. Templating then was performed and the results were recorded.
Templating was performed independently by two orthopaedic surgeons (JBAvM, RPAJ) and two orthopaedic residents (AMRPL, KEdK) to obtain information regarding interobserver variability. Each rater templated all 33 cases with the three methods described previously to obtain information regarding the method accuracy and interobserver variability. Two of the authors (JBAvM, an experienced orthopaedic surgeon, and AMRPL, an orthopaedic resident) templated the 16 uncemented THAs a second time to determine intraobserver variability. All cases were unknown to all raters, and raters were blinded to the results of the previously performed templating and the implanted prosthesis sizes. Interobserver and intraobserver variability were determined by an intraclass correlation (ICC) calculated with the online statistical tool of Mater Research Support Centre [18]. According to this reference, ICC can be interpreted as: 0 to 0.2 indicates poor agreement; 0.3 to 0.4 indicates fair agreement; 0.5 to 0.6 indicates moderate agreement; 0.7 to 0.8 indicates strong agreement; and greater than 0.8 indicates almost perfect agreement.
The literature suggests a ± 1 size estimation of the prosthesis size is adequate for a templating method [1, 3, 6, 9, 10, 16, 27, 30]. We therefore based our interpretations of appropriate sizes on a ± 1 size.
The templating results were categorized as either exact planned results or ± 1 size planned results. Templated prostheses sizes were plotted in a histogram accompanied by the normal distribution curve generated in SPSS® for Windows® (SPSS Inc). Histogram frequency plots with normal distribution curves were generated to illustrate the shape, center, and spread of the distribution of the obtained templating results.