Trials / Active Not Recruiting
Active Not RecruitingNCT03357445
AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study
Prospective, Multi Centre Evaluation of AVANTAGE® RELOAD Double Mobility Acetabular Cup - Clinical and Radiographic Outcomes
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 500 (actual)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Primary Osteoarthritis
- Post-Traumatic Arthritis
- Inflammatory Joint Disease
- Femoral Neck Fracture
- Femoral Head Necrosis
- Sequelae From Previous Hip Surgery
- Osteotomies
- Congenital Hip Dysplasia
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Avantage Reload cup | Patients receiving the Avantage Reload acetabular cup in total hip arthroplasty |
Timeline
- Start date
- 2011-10-14
- Primary completion
- 2027-04-27
- Completion
- 2027-04-27
- First posted
- 2017-11-29
- Last updated
- 2024-11-14
Locations
4 sites across 2 countries: France, Slovenia
Source: ClinicalTrials.gov record NCT03357445. Inclusion in this directory is not an endorsement.