This is a Post Marketing Clinical Follow Up study (PMCF) on the AVANTAGE RELOAD dual mobility system cup.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
500
Patients receiving the Avantage Reload acetabular cup in total hip arthroplasty
CHU Cote de Nacre
Caen, France
Hôpital Renée Sabran
Giens, France
CHU Lapeyronie
Montpellier, France
Hospital Novo Mesto
Novo Mesto, Slovenia
Survivorship
Implant survivorship
Time frame: 10 years post-surgery
Harris hip scores
To measure clinical efficacy
Time frame: 10 years post-surgery
EQ-5D
To measure clinical efficacy
Time frame: 10 years post-surgery
Radiographic Evaluation
Abnormalities determined on X-rays in the bone region surrounding the implant will be reported (radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc)
Time frame: 10 years post-surgery
Complications
Eventual complications occurred including dislocations and revisions/removals
Time frame: 10 years post-surgery
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