Prospective, Multi Centre Evaluation of AVANTAGE® RELOAD Double Mobility Acetabular Cup - Clinical and Radiographic Outcomes
Avantage Reload cup
Congenital Abnormalities+10
+ Developmental Dysplasia of the Hip
+ Femoral Fractures
Other Study
Summary
Study start date: October 14, 2011
Actual date on which the first participant was enrolled.The study objective is to document the patients' survivorship at 10 years and evaluate the performances at 3 months, 1, 2, 3, 5, 7 and 10 years post-surgery of the AVANTAGE RELOAD cup. Secondary objective is to evaluate the polyethylene wear between E1 and ARCOM. 500 patients was the enrollment goal with 2 subgroups. * Subgroup 1: prospective and non-controlled to satisfy ODEP (Orthopedic Device Evaluation Panel) requirements; * Subgroup 2: randomized and controlled to compare the polyethylene wear between the Arcom and the E1 liners.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.500 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Selection of subjects for this evaluation should be in accordance with the indications of the AVANTAGE® RELOAD with E1™ or ArCom™ liner specifically * Primary osteoarthritis * Post-Traumatic arthritis * Inflammatory joint disease (e.g. Rheumatoid arthritis) * Femoral neck fracture * Femoral head necrosis * Sequelae from previous hip surgery, osteotomies, etc. * Congenital hip dysplasia Additional inclusion criteria include: * Male or female * 18 years of age or older * Subjects willing to return for follow-up evaluations * Subjects who read, understand study information and give written consent (specific local regulatory requirements) Exclusion Criteria: * Exclusion criteria should be in accordance with Contraindications for the AVANTAGE® RELOAD: Absolute contraindications include: * Infection * Sepsis * Severe muscular, neurological or vascular deficiencies of the extremity involved * Bone destruction or poor bone quality Additional contraindications include: * Subjects unable to co-operate with and complete the study * Dementia and inability to understand and follow instructions * Neurological conditions affecting movement * Patient over 18 under law supervision
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Group II
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 4 locations
Hôpital Renée Sabran
Giens, FranceCHU Lapeyronie
Montpellier, FranceHospital Novo Mesto
Novo Mesto, Slovenia