Status:
TERMINATED
Post Market Clinical Follow-Up of the Zimmer Stafit Acetabular System
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteoarthritis, Hip
Fracture of Hip
Eligibility:
All Genders
18+ years
Brief Summary
This study is a Post Market Clinical Follow up study to fulfil the post market surveillance obligations according to Medical Device Directive and European Medical Device Vigilance System (MEDDEV) 2.12...
Detailed Description
The objective of this study is to obtain implant survival and outcome data on the Stafit Acetabular System by analysis of standard scoring systems, radiographs, and adverse event records. Data will b...
Eligibility Criteria
Inclusion
- Males and females
- Patients suffering from severe hip pain and disability requiring a primary total hip arthroplasty.
- 18 years minimum
- Patients able to participate in a follow-up program based upon physical examination and medical history
- Patients who have provided written informed consent by signing the Patient Informed Consent Form.
Exclusion
- Patients who are unwilling or unable to give informed consent, or to comply with the follow-up program
- Known pregnancy
- Revision hip arthroplasty
Key Trial Info
Start Date :
April 28 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 15 2019
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT04079114
Start Date
April 28 2011
End Date
July 15 2019
Last Update
June 30 2020
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