A novel radiopaque tissue marker for soft tissue localization and in vivo length and area measurements

Purpose The purpose of the study was to describe the characteristics and demonstrate proof-of-concept and clinical use of a barium sulfate infused polypropylene radiopaque tissue marker for soft tissue localization and in vivo measurement of lengths and areas. Methods Marker mechanical properties were evaluated by tensile tests. Biocompatibility was evaluated following 8-12 weeks' implantation in a pig model. Proof-of-concept of marker application was performed in a human cadaveric shoulder model, and methods for CT imaging and measurement of dimensions were established. Lastly, the method of clinical use of the markers was described in one patient undergoing arthroscopic rotator cuff repair (RCR). Results The radiopaque markers had a tensile strength of 28 +/- 4.7 N and were associated with minimal to mild inflammatory tissue reaction similar to polypropylene control. CT-based measurements showed relatively high precisions for lengths (0.66 mm), areas (6.97 mm(2)), and humeral orientation angles (2.1 degrees) in the cadaveric model, and demonstrated 19 +/- 3 mm medio-lateral tendon retraction and 227 +/- 3mm(2) increase in tendon area in the patient during 26 weeks following RCR. No radiographic leaching, calcification or local adverse events were observed. Conclusions The radiopaque tissue marker was biocompatible and had adequate strength for handling and affixation to soft tissues using standard suturing techniques. The marker could be used with low-dose, sequential CT imaging to quantitatively measure rotator cuff tendon retractions with clinically acceptable accuracy. We envision the radiopaque tissue marker to be useful for soft tissue localization and in vivo measurement of tissue and organ dimensions following surgery.