The Medacta International AMIStem-P Post-Marketing Surveillance Study
ArthrosisTraumatic Arthritis3 moreThis is a Post-Market Surveillance study of AMIStem-P femoral stem prosthesis
H1 Hip Resurfacing Arthroplasty
Hip OsteoarthritisHip Necrosis1 moreThis is a prospective, non-randomized, consecutive series, multicentre, observational study to evaluate the clinical outcome of ceramic-on- ceramic hip resurfacing arthroplasty using the ceramic, non-porous, non-cemented H1 Hip Resurfacing Arthroplasty. It includes a safety study followed by an efficacy study. Patients will be followed up for 10-years postoperatively. The primary aim is to confirm the safety of the H1 hip resurfacing prosthesis by demonstrating non-inferiority of the H1 device in terms of survivorship. The secondary is to evaluate superiority of the ceramic-on-ceramic H1 hip resurfacing prosthesis compared to Metal-on-Metal (MoM) hip resurfacing in terms of absence of metal ion release.The primary end point is revision for any reason.
PMCF Study on the Safety and Performance of the Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty...
Rheumatoid Arthritis With Adequate Bone QualityInflammatory Arthritis5 moreThis study is a multicenter, prospective, non-controlled post market clinical follow-up study. The objectives of this study are to confirm the safety and performance of the commercially available Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty.
Post Market Clinical Follow-up of EUROSCUP Fixe Acetabular Cup
Hip ArthropathyHip Osteoarthritis4 moreEUROSCUP Fixe is intended for use in primary and revision total hip replacement surgery. Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. As part of post market vigilance, EUROS will collect data on EUROSCUP Fixe performances and safety
A Single Centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Primary Hip...
Rheumatoid ArthritisOsteoarthritis6 moreThe purpose of this study is to monitor the performance and determine the metal ion release of the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip resurfacing surgery. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. A subset of patients will also have blood samples taken at regular intervals to allow the metal ion levels to be determined and undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored. DePuy decided to close this Study in 4Q 2009. The Study was terminated with effect from November 2010 to allow for the completion of the 5 year follow up assessments. Please note that subsequent to this decision DePuy voluntarily recalled the ASR products on 24 August 2010. Additional information regarding this voluntary recall and the follow-up of patients affected by the recall can be found at the following links http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON079157 and http://www.depuy.com/countries_list.
A Two Centre Study to Assess the Long-term Performance of the Pinnacle™ Cup With a Metal-on-Metal...
Rheumatoid ArthritisOsteoarthritis7 moreThe purpose of this study is to monitor the performance and determine the metal ion release of the Pinnacle™ Cup with a metal-on-metal bearing combination in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. A subset of patients will also have blood samples taken at regular intervals to allow the metal ion levels to be determined.
AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study
Primary OsteoarthritisPost-Traumatic Arthritis6 moreThis is a Post Marketing Clinical Follow Up study (PMCF) on the AVANTAGE RELOAD dual mobility system cup.
Prospective Study for the Evaluation of the Cementless Anatomic Femoral Stem Minimax -Launay
Primary OsteoarthritisSecondary Osteoarthritis6 moreThis is a post-marketing surveillance on MiniMAX Stem
Corin MiniHip and Trinity Cup Clinical Surveillance Study
Total Hip ArthroplastyOsteoarthritis5 moreThe aim of the study is to provide long term follow up data on the performance and safety of the Corin MiniHip and Trinity acetabular cup over a 10-year period.
Avenir® Cemented Hip Stem - PMCF
Primary OsteoarthritisPost-Traumatic Osteoarthritis of Hip5 moreThe objective of this post-market clinical follow-up study is to confirm the safety and performance of the Avenir® Cemented Hip stem when used in primary total hip arthroplasty.