A test result form was used to record mi-eye+TM, surgical arthroscopy, and MRI results. This form required a “positive” or “negative” result for all of several diagnoses: medial and lateral meniscal tears, intra-articular loose body, osteoarthritis (OA), osteochondritis dissecans (OCD), and tears of the anterior and posterior cruciate ligaments (ACL, PCL). MRI was performed at a variety of imaging facilities, but the images were interpreted by musculoskeletally trained radiologists.
The study was conducted in the operating room. After the patient was appropriately anesthetized, and the extremity prepared and draped, the mi-eye+TM procedure was performed immediately prior to surgical arthroscopy. A tourniquet was not used. At surgeon discretion, medial, lateral, or both approaches were used with the mi-eye+TM, and diagnostic arthroscopy was performed. During the procedure, the mi-eye+TM was advanced into the knee. Once in the synovial compartment, the external 14-gauge needle was retracted, exposing the unit’s optics. Visualization was improved by injecting normal saline through the lure lock in the mi-eye+TM needle arthroscope. An average of 20 mL of saline was used, though the amount varied with surgeon discretion. Subsequently, the surgeon visualized structures in the knee and documented all findings.
At the end of the mi-eye+TM procedure, the scheduled surgical arthroscopy was performed. After the surgical procedure, if there were no issues or complications, the patient was discharged from the study. No follow-up was required for the study, as arthroscopic findings served as the conclusive diagnosis for each patient, and no interventions were being studied. There were no complications related to use of the mi-eye+TM.
The mi-eye+TM device findings were compared with the MRI findings within individual pathologies, and a “per-patient” analysis was performed to compare the arthroscopic findings with those of the mi-eye+TM and the MRI. Additionally, we identified all mi-eye+TM findings and MRI findings that exactly matched the surgical arthroscopy findings. When a test had no false-positive or false-negative findings in comparison with surgical arthroscopy, it was identified as having complete accuracy for all intra-articular knee pathologies. For these methods, the 95% confidence interval was determined based on binomial distribution.
RESULTS
The mi-eye+ TM demonstrated complete accuracy of all pathologies for 97 (91.5%) of the 106 patients included in the study, whereas MRI demonstrated complete accuracy for 65 patients (61.3%) (P < .0001). All discrepancies between mi-eye+TM and surgical arthroscopy were false-negative mi-eye+TM results, as the mi-eye+TM did not reveal some aspect of the knee’s pathology for 9 patients. On the other hand, MRI demonstrated both false-negative and false-positive results, failing to reveal some aspect of the knee’s pathology for 31 patients, and potentially overcalling some aspect of the knee’s pathology among 18 patients.
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