Surgical arthroscopy is the gold standard for the diagnosis of intra-articular knee pathologies. Nevertheless, the use of arthroscopy for purely diagnostic purposes has been largely supplanted by noninvasive technologies, such as magnetic resonance imaging (MRI). Although MRI is considered the standard diagnostic tool for acute and chronic soft-tissue injuries of the knee, its use is not without contraindication and some potential inconveniences. Contraindications to MRI are well documented. In terms of inconvenience, MRI usually requires a separate visit followed by another visit to the prescribing physician. In addition, required interpretation by a radiologist may lead to a delay in care and increase in cost.
In the early 1990s, in-office needle arthroscopy was described as a viable means of diagnosing pathologies and obtaining synovial biopsies from the knee.1-3 Initial results were good, and the procedures had very low complication rates. Nevertheless, in-office arthroscopy of the knee is not yet widely performed, likely given concerns about the technical difficulties of in-office arthroscopy, the potential for patient discomfort, and the cumbersomeness of in-office arthroscopy units. However, significant advances have been made in the resolution capability of small-bore needle arthroscopy, resulting in much less painful procedures. Additionally, the early hardware designs, which mimicked operating room setups using towers, fluid irrigation systems, and larger arthroscopes, have been replaced with small-needle arthroscopes that use syringes for irrigation and tablet computers for visualization (Figures 1A, 1B).
The mi-eye+TM technology (Trice Medical) is a small-bore needle unit for in-office arthroscopy with digital optics that does not need an irrigation tower. We conducted a pilot study of the sensitivity and specificity of the mi-eye+TM unit in comparison with MRI, using surgical arthroscopy as a gold-standard reference. We hypothesized that the mi-eye+TM needle arthroscope, which can be used in an office setting, would be equivalent to the standard of care (MRI) for the diagnosis of intra-articular pathology of the knee.
METHODS
Central regulatory approval for this prospective, multicenter, observational study was obtained from the Western Institutional Review Board for 3 of the sites, and 1 institution required and was granted internal Institutional Review Board approval.
The study was performed by 4 sports medicine orthopedic surgeons experienced in using the mi-eye+TM in-office arthroscope. Patients were enrolled from December 2015 through June 2016. Inclusion criteria were an indication for an arthroscopic procedure of the knee based on history, physical examination, and MRI findings. Patients were excluded from the study if there were any contraindications to completing an MRI. Acute hemarthroses of the knee or active systemic infections were also excluded. Once a patient was identified as meeting the criteria for participation, informed consent was obtained. Of the 113 patients who enrolled, 7 did not have a complete study dataset available, leaving 106 patients (53 males, 53 females) in the study. Mean age was 47 years (range, 18-82 years).
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