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Joint Disease clinical trials

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NCT ID: NCT03865667 Active, not recruiting - Joint Disease Clinical Trials

Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Preserve Femoral Stem

Start date: January 15, 2019
Phase:
Study type: Observational

MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in Europe. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.

NCT ID: NCT03404245 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

an On-demand Program to EmpoweR Active Self-management (OPERAS)

OPERAS
Start date: January 23, 2019
Phase: N/A
Study type: Interventional

Self-management is a key component of successful chronic disease management and patients can benefit from learning about how daily activities and treatments relate to their symptoms and health status on an ongoing basis. The primary goal of this randomized controlled trial is to assess the efficacy of an e-health intervention, OPERAS, which includes two components: 1) the use of a newly developed web app to self-monitor symptoms/disease activity and treatment use, and help patients identify when a medical visit or treatment change is needed; 2) remote activity counselling provided by a physiotherapist, with the use of a wearable device (Fitbit) and the app to provide activity level feedback. The app component of OPERAS is hosted by the secure network of Arthritis Research Canada.

NCT ID: NCT03391323 Active, not recruiting - Osteoarthritis Clinical Trials

Medacta GMK Sphere® vs. Medacta GMK PS Post-Market Outcomes Study

Start date: April 2015
Phase: N/A
Study type: Interventional

The study is a prospective, randomized comparison of total knee arthroplasty with the Medacta GMK Sphere® knee compared to the Medacta GMK PS knee, with comparison to data from previous trials of similar study design.

NCT ID: NCT03294408 Active, not recruiting - Knee Osteoarthritis Clinical Trials

Multimodal Imaging of Subchondral Bone in Knee Osteoarthritis : Predictive Model

MOSART
Start date: November 29, 2016
Phase: N/A
Study type: Interventional

Predictive factors of osteoarthritis progression are not yet well understood. However, a growing role attaches importance to the subchondral bone. The aim of the present project is to determine predictive factors of progression of osteoarthritis at the knee by a multimodal characterization of subchondral bone by Medical Resonnance Imaging, direct high resolution digitization radiographs and bone texture analysis. At the end of the project, an innovative imaging device, combining semi-automatic softwares for texture analysis, control detection and image registration would be supplied. This will enable on the one hand a more accurate and reproducible way to measure the joint space width of the affected compartment and on the other hand, an assistance to better detect patients at risk of progression of their knee osteoarthritis. Identifying These "progressors" patients might permit their selection in clinical trials at baseline adapted to their severe disease, using for example biologic treatments targeting knee osteoarthritis. The main objective of this study is to analyze the predictive capacities of bone texture parameters measured on the high-resolution radiography of the knee on the structural evolution of the knee osteoarthritis at 3 years.

NCT ID: NCT02823834 Active, not recruiting - Joint Disease Clinical Trials

PMCF Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components

Start date: June 16, 2017
Phase:
Study type: Observational

MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.

NCT ID: NCT02351414 Active, not recruiting - Joint Disease Clinical Trials

Post Market Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts

AMETHYST
Start date: June 15, 2015
Phase:
Study type: Observational

MPO is conducting this PMCF study to evaluate the safety and efficacy of its EVOLUTION® Total Knee Arthroplasty (TKA) components marketed in the EU. These types of studies are required by regulatory authorities for all devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.

NCT ID: NCT02314702 Active, not recruiting - Joint Disease Clinical Trials

Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems

Start date: September 4, 2015
Phase:
Study type: Observational

MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the EU. These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.

NCT ID: NCT02285842 Active, not recruiting - Joint Disease Clinical Trials

Post Market Clinical Follow-Up Study Protocol for CONSERVE® Press-Fit Femoral Components

Start date: December 2014
Phase:
Study type: Observational

MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the EU. These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.

NCT ID: NCT02239783 Active, not recruiting - Joint Disease Clinical Trials

Post Market Clinical Follow-Up Study Protocol for PROFEMUR® TL Modular Femoral Stems

Start date: November 2014
Phase:
Study type: Observational

Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) marketed in the European Union (EU) . These types of studies are required by regulatory authorities for all THA devices that do not have clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.

NCT ID: NCT02149667 Active, not recruiting - Joint Disease Clinical Trials

Post Market Clinical Follow-up Study Protocol for DYNASTY® BioFoam® Acetabular Components

Start date: December 2014
Phase:
Study type: Observational

Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) components marketed in the European Union (EU) . These types of studies are required by regulatory authorities for all THA devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.