The Development of a Vertebra Localizing Aid Medical Device

The current method of incision localization in many surgical procedures requires a doctor to reference a medical image, such as an X-ray, to judge where on the body an incision should be made. However, the precise information of the scan is not shown on the patient's skin. Surgeons commonly use palpation to locate the point of incision. They may feel for the area directly or find landmarks under the skin and estimate the location from there. This can be challenging due to the difficulty of feeling and distinguishing each vertebra, especially for new surgeons, since palpation is a skill derived through experience. If palpation proves ineffective, they may be forced to use fluoroscopy. By referencing the fluoroscopy image the surgeon moves a radiopaque marker, such as their surgical tool, closer to the area of interest. Fluoroscopy is time-consuming, and exposes medical personnel and the patient to radiation. Many fluoroscopic images may be required in a single procedure. The purpose of this study is to test the efficacy and benefits of a new medical device that will aid in radiological localization. The hypothesized outcome would be smaller incisions, faster localization and a reduction in fluoroscopy use. By identifying the efficacy of this new medical device, "Target Tape", there is the potential outcome of making smaller incisions, faster localization, a reduction in fluoroscopy use and a reduced chance in surgical error and the associated costs. Target Tape is a non invasive device that is in a grid format that is placed against the subject's skin. The grid pattern will then appear on the medical imaging scan. The medical practitioner can correlate device grid on the body to the medical scan image to make their incisions in more accurate locations.

Sex

All

Minimum age

18 Years

Maximum age

99 Years

Inclusion Criteria:

* Surgical spine procedures involving the use of medical imaging to determine the vertebra site (ex. fusions, tumor removals, fracture repairs, discectomies). The medical imaging scans may include planar X-rays, fluoroscopy, CT or MRI scans
* Able and willing to consent

Exclusion Criteria:

* Subjects who may have allergies to medical skin adhesives

• BACKGROUNDKim KD, Li W, Galloway CL. Use of a radiopaque localizer grid to reduce radiation exposure. Ann Surg Innov Res. 2011 Aug 9;5:6. doi: 10.1186/1750-1164-5-6. PMID 21827694