AVANTAGEĀ® RELOAD Double Mobility Acetabular Cup -Clinical Study (NCT03357445) | Clinical Trial Compass
Active ā Not RecruitingNot Applicable
AVANTAGEĀ® RELOAD Double Mobility Acetabular Cup -Clinical Study
France, Slovenia500 participantsStarted 2011-10-14
Plain-language summary
This is a Post Marketing Clinical Follow Up study (PMCF) on the AVANTAGE RELOAD dual mobility system cup.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 AVANTAGEĀ®
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