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
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.
Sequelae of Developmental Dysplasia of the Hip
Developmental Dysplasia of the HipHip DysplasiaThe aim of this study is to assess long term effects of developmental dysplasia of the hip (DDH) to overall health and quality of life later in life. We compare hip radiographs, hip symptoms, clinical examination, head asymmetry, dental examination and intraoral scans of 170 children and young adults treated for DDH in their childhood with age and sex matched controls.
A Randomised Study to Compare Metal Ion Release and Long-term Performance of the Pinnacle™ Cup With...
OsteoarthritisPost-traumatic Arthritis4 moreThe purpose of this study is to monitor the performance and compare the metal ion release of two bearing combinations, ceramic-on-metal and metal-on-metal in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to one of the bearing combinations and will be evaluated at regular intervals using, patient, clinical and x-ray assessments. Patients will also have blood samples taken at regular intervals to allow the metal ion levels to be determined.
Study to Evaluate the Safety and Efficacy of OR3O™ Dual Mobility System vs. Conventional Single...
Degenerative Hip Joint DiseaseRheumatoid Arthritis (RA)5 moreThe purpose of this study is to compare OR3O™ Dual Mobility System to a conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Data collected in this study will be used to support National Medical Products Administration (NMPA) regulatory approval of OR3O™ Dual Mobility System in China as well as to support and maintain product registration in global markets. Primary Objective: Assess safety and efficacy of the OR3O™ Dual Mobility System in Primary THA at 1 year postoperative. Secondary Objective(s): Assess safety and efficacy of the OR3O™ Dual Mobility System and compatible components in Primary THA up to 2 years after surgery. Other Objective(s): Assess the hip dislocation and hospital readmission up to 2 years after device implantation. 4 study sites in China.