Status:
ACTIVE_NOT_RECRUITING
AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study
Lead Sponsor:
Zimmer Biomet
Conditions:
Primary Osteoarthritis
Post-Traumatic Arthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a Post Marketing Clinical Follow Up study (PMCF) on the AVANTAGE RELOAD dual mobility system cup.
Detailed Description
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 objec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 14 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03357445
Start Date
October 14 2011
End Date
April 27 2027
Last Update
November 14 2024
Active Locations (4)
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1
CHU Cote de Nacre
Caen, France
2
Hôpital Renée Sabran
Giens, France
3
CHU Lapeyronie
Montpellier, France
4
Hospital Novo Mesto
Novo Mesto, Slovenia