OARSI 2012 POSTER PRESENTATION

X-RAY ACQUISITION CHALLENGES IN CLINICAL TRIALS: CHALLENGES AND SOLUTIONS POSED BY THE SYNAFLEXER
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Authors: R. McCarrie C.G. Miller, Ph.D. BioClinica, Inc., Newtown, PA, USA

INTRODUCTION:

The Synaexer is utilized in many OA trials and by the OAI to standardize positioning. However this device can be incompatible with many x-ray machines, can sometimes cause discomfort for subjects, and may not offer true standardization.
Figure 1

C A D
Figure 2 Figure 3 Figure 4 Figure 5

OBJECTIVES:

1) Improve compatibility of the Synaexer with x-ray machines 2) Improve subject comfort when standing on the Synaexer 3) Evaluate the standardization of the Synaexer

METHODS:

In past clinical trial experience in which the Synaexer was used, the Synaexer The measurements are of the 4 parts of the trapezium which make up the angled is often incompatible with many x-ray machines because the imaging plate/bucky plate for the foot positioning. This means the feet are angled at between 8 and 12 cannot extend to the oor such the standing knee x-ray is not centered on the lm degrees. Measurements are in inches. and all required anatomy captured on the image. Also, subjects of short stature experienced discomfort and x-ray machine incompatibility was reported. The Number A B C D source of the subject discomfort is the chamber that houses the two rows of calibration markers/beads. This chamber protrudes from the back a Synaexer 1 11 78" 11 78" 3" 1 14" by approximately 5 cm and when a subject of small stature is positioned on the 2 11 34" 11 58" 3" 1 18" device the chamber comes in contact with the symphysis pubis. Finally a further challenge uncovered where it was noted that not all Synaexers are identical. 3 11 34" 11 12" 3" 1 14"

TABLE 1 AND FIGURE 5:

RESULTS:

After careful evaluation of two of the challenges a solution was developed and is presented here. A two-part wooden platform was created. Part one is the platform on which the Synaexer is placed. This platform elevates the Synaexer and subject to the average height to which most imaging plates/buckies can extend (See Fig 1). A secondary benet is for the x-ray technologist who can now observe the back of the subjects knee more easily. Part two is the wedge which is housed within the platform. This wedge was designed to t securely around the Synaexer angle and raises the subject such that the likelihood of a subjects symphysis pubis coming in contact with the calibration marker/bead chamber is reduced (See Fig 2, 3 and 4). Nine Synaexers were evaluated and after careful measurement it was determined that eight of the nine Synaexers were unique in shape as described in Table 1. Since the wedges would not t the Synaexer snugly.

4 5 6 7 8 9

11 58" 11 58" 11 34" 11 34" 11 34" 11"

11 12" 11 58" 11 58" 11 58" 11 58" 11"

3 14" 3" 3" 3" 3 18" 3 12"

1 12" 1 18" 1 18" 1" 1 12" 1 38"

CONCLUSION:

For clinical trials where the Synaexer is used the two-part platform may be necessary to avoid potential subject discomfort and x-ray machine incompatibility. The Synaexer in its current conguration needs further evaluation regarding the effect on image standardization.

SPONSOR: BioClinica, Inc. DISCLOSURE STATEMENT: None ACKNOWLEDGMENTS: Ron Marklov is to be thanked for his carpentry expertise; John Lynch, Ph.D. of UCSF for his help in conrming the proportions and providing a data point; Hui Jing Yu, Ph.D. for editing and managing the poster production. CORRESPONDENCE ADDRESS: rebecca.mccarrie@bioclinica.com REFERENCE: A 2-Year Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of an Oral Selective Inos Inhibitor in Subjects with Symptomatic Osteoarthritis of the Knee. M-P. Hellio le Graverand-Gastineau, R. Clemmer, P. Redifer, R. M. Brunell, C. W. Hayes, K. Brandt, S. B. Abramson, P. T. Manning, C. G. Miller, E. Vignon.

Global clinical trial solutions. Real-world results.

OA Biomakers Global Initiative July 12 14 , 2012 Hilton Head Island, South Carolina, US
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