COREV 2.0 PMCF-Study on Manual and Navigated Revision Knee Patients
Knee OsteoarthritisBone; Deformity3 moreThe Columbus® Revision endoprosthetic system is bearing the CE-mark. This means that within the scope of this observational study the patient will not be subjected to any additional stressful, study-related medical examinations or treatment measures. The treatment will be carried out exclusively according to medical standards. The study therefore only serves the purpose of observing this standard-compliant treatment and specifically documenting it scientifically.
SEBBIN Round, Anatomical and Biconvex Gluteal Implants
ComplicationProsthesis DurabilityThis study is part of the clinical evaluation of SEBBIN silicone gel-filled gluteal implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.
Implant-supported Fixed Dental Prostheses (FDPs) With Cantilever Extension
Dental Implant FailedProsthesis Failure1 moreTo report the clinical and radiographic outcomes of implant-supported fixed dental prostheses with full-ceramic cantilever extensions (FDPCs) after a function time ≥ 12 months.
Vantage Mobile Bearing Total Ankle System Post Market Clinical Follow-up (Outside US)
Rheumatoid ArthritisArthritis of Ankle2 moreThe objectives of this study are to evaluate the performance and safety of the Vantage Mobile-Bearing Total Angle System. This study will follow subjects for a period of up to 10 years post-surgery.
Deep Learning Algorithms for Prediction of Lymph Node Metastasis and Prognosis in Breast Cancer...
Breast Neoplasm FemaleEarly-stage Breast Cancer4 moreThis bi-directional, multicentre study aims to assess multiparametric MRI Radiomics-based prediction model for identifying metastasis lymph nodes and prognostic prediction in breast cancer.
Identification of Infections in Hip Arthroplasty Loosening.
LooseningProsthesisRecent data showed that the rate of periprosthetic infections in patients undergoing a hip arthroplasty revision for aseptic loosening is higher than what can be ascertained with conventional methods. The study aims to assess the adequacy of next-generation sequencing of 16s ribosomal ribonucleic acid (rRNA) gene amplicons for identifying occult infections and improving the diagnostic workup. Moreover, additional testing has been planned in order to increase knowledge on the etiopathogenesis of infection.
A Sensorimotor Prosthesis for the Upper Limb
Prosthesis DurabilityProsthesis User3 moreThe finger and fingertip are the most frequently amputated body parts, due to work-related incidents. Yet because of space, weight and cost constraints, prosthetic fingers and fingertips are heavy and bulky with limited active motion and sensation. Most are basic variations on the hook and claw. Lower limb prostheses have become extremely technologically advanced in their design and materials, and upper limbs lag behind in all of these areas. This is due to the complexity of the anatomy and function of the upper limb compared to the lower. There are no commercially available prostheses that offers direct sensory feedback and as such, rely on visual feedback from the wearer. The original PROLIMB study (PROLIMB I) used a Leap Motion Controller (LMC) to investigate the type of grasp adaptation that have been undertaken by patients during the rehabilitation process following amputation and compared this to similar data from healthy volunteers. PROLIMB I also looked at refining the tactile feedback system by investigating the sensation felt on amputation sites in order to feed this information into the haptic feedback system. The vision of the PROLIMB II project is to build on the work completed in PROLIMB I and develop and combine mechanistic models of hand motion and haptic sensing to deliver novel, affordable body-powered prosthetic fingertip digits with enhanced motion and sensation to address current clinical needs and support the quality of life of amputees. With collaboration from the University of Warwick (UoW) and University College London (UCL), Steeper Group and Naked Prosthetics the PROLIMB II study will aim to model, design, fabricate and validate a body-powered prosthetic fingertip digit with integrated sensory feedback. The University Hospital Coventry & Warwickshire (UHCW) will provide the clinical facility with which to assess the comfort, usability and acceptance of this prosthetic in the daily lives of patients with digit amputations. This project will be a proof of concept study with verification of the prosthetic in motion capture (gait) laboratories as well as the use of simple validation data collection over a longer period.
Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements...
Aortic Valve StenosisAortic Valve Regurgitation1 moreData on valve performance following ViV-TAVR has usually been obtained with the use of Doppler-echocardiography. However, some reports have shown significant discordances in the evaluation of mean transvalvular gradient between echocardiography and catheterization, with an overestimation of the real gradient with echo (vs. cath) in most cases. Thus, the incidence of procedural-device failure may be lower than that reported in the ViV-TAVR literature,
Patient-reported Outcome Measures in Patient Underwent Total Hip and Knee Arthroplasty
Hip OsteoarthritisKnee Osteoarthritis1 moreRegistry of Galeazzi Orthopedic Institute: provides for the regular and systematic collection of all data (clinical and some PROMs) obtained from patients undergoing hip and knee arthroplasty to which questionnaires are proposed investigating the specific functional sphere of the joints undergoing surgery (Knee injuryOsteoarthritisOutcomeScore (KOOS-PS) and Hip injuryOsteoarthritisOutcomeScore (HOOS-PS) but also the sphere of general health (ShortForm health survey-12 (SF-12) and VisualAnalogueScale (VAS)) , in addition, of course, to the satisfaction rate.
Multicenter Mpact DM France
Total Hip ArthroplastySurvival1 moreThe primary objective of the study is to evaluate the 10-year performance of the MPACT DM cup in the treatment of patients requiring total hip arthroplasty. The primary endpoint is the 10-year life span of the prosthesis according to the Kaplan Meier curve.