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Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK
Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its EVOLUTION® Revision CCK Tibia and EVOLUTION® Revision CCK Femur with EVOLUTION® CCK Tibial inserts. These type of studies are required by regulatory authorities for all devices that have been approved in Europe (EU) to evaluate the medium and long term clinical evidence. This study has been designed in accordance with MEDDEV2.12/2 rev 2 (European Medical Device Vigilance System) and ISO (International Organization for Standardization) 14155:2011 guidelines.
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Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert
MicroPort Orthopedics Inc. (MPO) plans to market the EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® NitrX™ CS/CR Non-Porous Femur with the EVOLUTION® Cruciate Sacrificing (CS) Tibial Insert globally, including in the European Union (EU). MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and effectiveness of the EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® NitrX™ CS/CR Non-Porous Femur. These components are used along with the EVOLUTION® Cruciate Sacrificing (CS) Tibial Insert components that is marketed in the European Union (EU). This type of data collection is required by regulatory authorities for all TKA...
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Post Market Clinical Follow-Up Study for PROFEMUR® Preserve Classic Femoral Stem
Sponsor is conducting this post market clinical study to evaluate the safety and effectiveness of its PROFEMUR® Preserve Classic Femoral Stem. This type of study is required by regulatory authorities for all devices that have been approved in Europe (EU) to evaluate the medium and long-term clinical evidence. This study has been designed in accordance with MEDDEV2.12/2 (European Medical Device Vigilance System) rev2 and ISO (International Organization of Standardization) 14155:2011 guidelines.
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Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
This is a prospective, multi-center open-label single arm post-market study where the purpose is to evaluate the effectiveness and safety of the market approved Spinal Simplicity Minuteman G5 MIS Fusion Plate and bone graft material in patients with degenerative conditions of the lumbar spine resulting in chronic low back pain with lower extremity symptoms and concurrent neurogenic claudication. The indication for the device under study is degenerative conditions of the lumbar spine resulting in back pain with lower extremity symptoms and neurogenic claudication.
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Post-Market Clinical Study on a Modular SI Joint Fusion System
A prospective study on the use of the TransLoc 3D SI Joint Fusion System for patients with sacroiliac joint disruptions or degenerative sacroiliitis.
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Pravastatin and Alkali Therapy in Patients With Autosomal Dominant Polycystic Kidney Disease
This is an one-year open-label study to determine treatment efficacy and feasibility of a trial that uses open-label interventions in ADPKD patients.
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Quest to Analyze One Thousand Humans Meditating
This study will be focused on assessing the molecular, physiological, and emotional correlates of an intensive meditation experience in the context of a retreat setting in a large 2000 plus-person cohort comprised of healthy and clinical populations.
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Ready, Set, Go! A Physical Fitness Intervention for Children With Mobility Challenges
Barriers to keeping and maintaining fitness as a young person with a disability exist across many domains of access to community locations such as fitness centers, so looking outside of these establishments may be necessary to advance fitness. This study is aimed at piloting a program that would address some of these barriers by hosting a modified after school running program with an underserved population in an accessible way. There is a second option to participate outside of school.
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Recapturing Immune Tolerance to Pegloticase for the Management of Tophaceous Gout
This safety and feasibility, open-label study of up to 9 subjects will examine a group of subjects with poorly controlled tophaceous gout (intolerant to or ineffective oral urate lowering agents and loss of prior Pegloticase response) pre-treated with Rituximab to recapture response to Methotrexate-Pegloticase.
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RENEW-AI: Personalizing Scleroderma Management With an AI Health Coach
The purpose of this pilot study is to explore the use of a large language model (LLM) in providing education and behavioral health coaching for individuals with Systemic Sclerosis (SSc). The goal of the LLM is to help user set or modify behavioral goals, provide education, or emotional support as needed by the participant. The primary outcome for this study is to assess the feasibility and acceptability of using an AI-supported health coaching tool over a four-week period.
