A Prospective, Blinded, Multicenter Clinical Trial to Compare the Efficacy, Accuracy, and Safety of In-Office Diagnostic Arthroscopy With Magnetic Resonance Imaging and Surgical Diagnostic Arthroscopy

作者：Gill Thomas J^*; Safran Marc; Mandelbaum Bert; Huber Bryan; Gambardella Ralph; Xerogeanes John

来源：Arthroscopy-The Journal of Arthroscopic and Related Surgery, 2018, 34(8): 2429-2435.

DOI：10.1016/j.arthro.2018.03.010

Purpose: The purpose of this study was to compare the efficacy, accuracy, and safety of in-office diagnostic arthroscopy with magnetic resonance imaging (MRI) and surgical diagnostic arthroscopy. Methods: A prospective, blinded, multicenter, clinical trial was performed on 110 patients, ages 18 to 75 years, who presented with knee pain. The study period was April 2012 to April 2013. Each patient underwent a physical examination, an MRI, in-office diagnostic imaging, and a diagnostic arthroscopic examination in the operating room. The attending physician completed clinical report forms comparing the in-office arthroscopic examination and surgical diagnostic arthroscopy findings on each patient. Two blinded experts, unaffiliated with the clinical care of the study's subjects, reviewed the in-office arthroscopic images and MRI images using the surgical diagnostic arthroscopy images as the "control" group comparison. Patients were consecutive, and no patients were excluded from the study. Results: In this study, the accuracy, sensitivity, and specificity of in-office arthroscopy was equivalent to surgical diagnostic arthroscopy and more accurate than MRI. When comparing in-office arthroscopy with surgical diagnostic arthroscopy, all kappa statistics were between 0.766 and 0.902. For MRI compared with surgical diagnostic arthroscopy, kappa values ranged from a low of 0.130 (considered "slight" agreement) to a high of 0.535 (considered "moderate" agreement). The comparison of MRI to in-office arthroscopy showed very similar results as the comparison of MRI with surgical diagnostic arthroscopy, ranging from a low kappa of 0.112 (slight agreement) to a high of 0.546 (moderate agreement). There were no patientrelated or device-related complications related to the use of in-office arthroscopy. Conclusions: Needle-based diagnostic imaging that can be used in the office setting is statistically equivalent to surgical diagnostic arthroscopy with regard to the diagnosis of intra-articular, nonligamentous knee joint pathology. In-office diagnostic imaging can provide a more detailed and accurate diagnostic assessment of intra-articular knee pathology than MRI. Based on the study results, in-office diagnostic imaging provides a safe, accurate, real-time, minimally invasive diagnostic modality to evaluate intra-articular pathology without the need for surgical diagnostic arthroscopy or high-cost imaging.

• 出版日期2018-8