Trials / Active Not Recruiting
Active Not RecruitingNCT03372278
PMCF Study on the Safety and Performance of the Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty
Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty. A Multicenter, Prospective, Non-controlled Post Market Clinical Follow-up Study
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 250 (actual)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study is a multicenter, prospective, non-controlled post market clinical follow-up study. The objectives of this study are to confirm the safety and performance of the commercially available Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty.
Detailed description
The objectives of this study are to confirm the safety and performance of the Zimmer Maxera Cup mated with either a BIOLOX® delta or BIOLOX® OPTION femoral head when used in primary total hip arthroplasty. In total 250 patients will be enrolled into the study at up to 10 sites.All potential study subjects will be required to participate in the Informed Consent Process.
Conditions
- Rheumatoid Arthritis With Adequate Bone Quality
- Inflammatory Arthritis
- Osteoarthritis, Hip
- Avascular Necrosis
- Post-traumatic; Arthrosis
- Congenital Hip Dysplasia
Timeline
- Start date
- 2013-01-01
- Primary completion
- 2027-01-01
- Completion
- 2028-12-01
- First posted
- 2017-12-13
- Last updated
- 2025-06-15
Locations
8 sites across 8 countries: Australia, Belgium, Canada, Finland, France, Netherlands, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT03372278. Inclusion in this directory is not an endorsement.