US FDA best practices for initiating early feasibility studies for neurological devices in the United States.

This article describes the efforts of the US Food and Drug Administration (FDA) Office of Neurological and Physical Medicine Devices to facilitate early clinical testing of potentially beneficial neurological devices in the US. Over the past 5 years, the FDA has made significant advances to this aim by developing early feasibility study best practices and encouraging developers and innovators to initiate their clinical studies in the US. The FDA uses several regulatory approaches to help start neurological device clinical studies, such as early engagement with sponsors and developers, in-depth interaction during the FDA review phase of a regulatory submission, and provision of an FDA toolkit that reviewers can apply to the most challenging submissions.

FDA Regulation of Neurological and Physical Medicine Devices: Access to Safe and Effective Neurotechnologies for All Americans.

The United States Food and Drug Administration (FDA) ensures that patients in the U.S. have access to safe and effective medical devices. The Division of Neurological and Physical Medicine Devices reviews medical technologies that interface with the nervous system. This article addresses how to navigate the FDA's regulatory landscape to successfully bring medical devices to patients.

Kinematic analysis of dynamic shoulder motion in patients with reverse total shoulder arthroplasty.

BACKGROUND: Reverse total shoulder arthroplasty (rTSA) has been used to treat patients with irreparable rotator cuff dysfunction. Despite the proven clinical efficacy, there is minimal information regarding the underlying changes to the shoulder kinematics associated with this construct. Therefore, we sought to examine the kinematics of dynamic shoulder motion in patients with well-functioning rTSA. METHODS: We tested 12 healthy subjects and 17 patients with rTSA. All rTSA patients were able to elevate their arms to at least 90° and received the implant as the primary arthroplasty at least 6 months before testing. On average, the rTSA patients elevated their arms to 112° ± 12° (mean ± SD) and reported an American Shoulder and Elbow Surgeons outcome score of 90.6 ± 6.3. A 3-dimensional electromagnetic motion capture device was used to detect the dynamic motion of the trunk, scapula, and humerus during bilateral active shoulder elevation along the sagittal, scapular, and coronal planes. RESULTS: In both healthy and rTSA shoulders, the majority of the humeral-thoracic motion was provided by the glenohumeral motion. Therefore, the ratio of glenohumeral to scapulothoracic (ST) motion was always greater than 1.62 during elevation along the scapular plane. In comparison to healthy subjects, however, the contribution of ST motion to overall shoulder motion was significantly increased in the rTSA shoulders. This increased contribution was noted in all planes of shoulder elevation and was maintained when weights were attached to the arm. CONCLUSION: Kinematics of the rTSA shoulders are significantly altered, and more ST motion is used to achieve shoulder elevation.

Three-dimensional motion of the scapula and shoulder during activities of daily living.

The purpose of this study was to describe 3-dimensional scapular motion during the activities of daily living (ADL) and the full range of arm motion, and to suggest a standardized method for evaluating scapular mobility. Eight healthy subjects between the ages of 25-40, with no prior history of shoulder pathology or surgery for the past 12 months, were recruited for this study. Touching 8 predetermined landmarks on the head and the trunk was used to simulate ADL. Touching the contralateral ear and contralateral shoulder resulted in the maximum scapular protraction 46 degrees (8 degrees) and 48 degrees (8 degrees), respectively, and the maximum degrees of the scapular anterior tilt, -11 degrees (4 degrees) and -11 degrees (5 degrees), respectively. Asking patients to reach to the back of the neck, and the contralateral shoulder, the clinician can evaluate the overall scapular mobility in all directions. A protocol controlling the performance variability during ADL tasks was suggested to improve the clinical evaluation of the shoulder joint complex. Findings of this study can guide clinicians to identify specific tasks which may relate to particular shoulder girdle dysfunction.