The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads when used for primary and revision total shoulder arthroplasty (implants and instrumentation) at 1,3,5,7 and 10 years*. Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads have been on the market since 2007, but have insufficient data to support 10 years of clinical history. Therefore, a prospective aspect to the study will...
The objective of this retrospective/prospective consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Versa-Dial Reverse Ti Glenosphere when used for primary total shoulder arthroplasty, fractures and revision total shoulder arthroplasty (implants and instrumentation) at a 1,2,3,5,7 and 10-year follow-up* to meet EU Medical Device and other regulatory requirements for post market surveillance. Because Comprehensive Reverse Ti Glenospheres have only been on the market since 2009, a prospective aspect to the study will be utilized as well in order to collect long-term...
The primary objective of this study is to evaluate the safety and performance of the Modulus 3D-printed titanium interbody implant in patients undergoing thoracic and/or lumbar XLIF as measured by reported complications, radiographic outcomes, and patient-reported outcomes.
The researchers are trying to identify molecular mechanisms that control spine deformity and degenerative changes that can be used for therapeutic strategies.
The study will utilize pre-post survey measures to evaluate Project ECHO for ILD with respect to an initial set of practice and clinical outcomes and relies on questionnaire data obtained from providers participating in Project ECHO for ILD at baseline, at 6 months, and at study end.
In this study, a total of 219 subjects from the MOON nested cohort will be studied at CCF, Vanderbilt and OSU, Table 1. Among them, some will have added MRI during their 10-year visit for the MOON study. Some subjects who finished their 10-year visit for the MOON Onsite study already will be called back to have MRI. PROMs and other information of these subjects will be collected through the MOON study.
The primary objective of this study is to evaluate the safety and performance of anterior cervical spine surgery using the NuVasive anterior cervical plate (ACP) System as measured by reported complications, radiographic outcomes, and patient-reported outcomes (PROs).
This prospective, randomized, controlled, blinded clinical trial is designed to assess the incidence of all time and all types of wound-related complications following total joint arthroplasty (TJA) when two different types of topical skin adhesives are used to close the incision.
This is an open-label study to evaluate the long-term efficacy and safety of KZR-616 in patients with active PM or DM who completed the double-blind treatment period of Study KZR-616-003, up to and including the Week 32 Visit, prior to the first dose of open-label KZR-616.
Prospective/Retrospective data analysis, chart reviews and clinical outcomes of minimally invasive spine surgery