Congenital Hip Dysplasia, Femoral Head Necrosis, Femoral Neck Fracture, Inflammatory Joint Disease, Osteotomies, Post-Traumatic Arthritis, Primary Osteoarthritis, Sequelae From Previous Hip Surgery
Conditions
Keywords
Total hip Arthroplasty, Hip implant
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 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.
Interventions
OTHERAvantage Reload cup
Patients receiving the Avantage Reload acetabular cup in total hip arthroplasty
Sponsors
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
The two subgroups will have the medical device with the following objectives: Subgroup 1 Prospective non Controlled to Document long term performance of AVANTAGE® RELOAD. Subgroup 2 Randomized Controlled Trial to Evaluate wear rate of E1 liner in comparison to ArCom® liner.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survivorship | 10 years post-surgery | Implant survivorship |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Harris hip scores | 10 years post-surgery | To measure clinical efficacy |
| EQ-5D | 10 years post-surgery | To measure clinical efficacy |
| Radiographic Evaluation | 10 years post-surgery | Abnormalities determined on X-rays in the bone region surrounding the implant will be reported (radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc) |
| Complications | 10 years post-surgery | Eventual complications occurred including dislocations and revisions/removals |
Countries
France, Slovenia
Outcome results
None listed