Post Market Clinical Follow-Up Study of the Zimmer Stafit Acetabular System. A Multicenter, Prospective, Non-controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Hip
- Sponsor
- Zimmer Biomet
- Enrollment
- 166
- Primary Endpoint
- Dislocation Rate
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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) 2.12-2. The data collected from this study will serve the purpose of confirming safety and performance of the Zimmer Stafit Acetabular System.
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 be used to monitor pain, mobility, dislocation rate and implant survival, and to confirm the long-term safety and performance of the Stafit Acetabular System in primary total hip arthroplasty. The study design is a multi-center, prospective, non-controlled, consecutive cohort post market clinical follow-up study, involving orthopedic surgeons skilled in total hip arthroplasty procedures and experienced with the Stafit Acetabular System.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •Patients who are unwilling or unable to give informed consent, or to comply with the follow-up program
- •Known pregnancy
- •Revision hip arthroplasty
Outcomes
Primary Outcomes
Dislocation Rate
Time Frame: 2 years
Assessed by counting the number of implant dislocations
Implant Survival
Time Frame: 3 years postoperatively, due to early study termination
Represents the implants that survived by counting the number of implants revised.
Secondary Outcomes
- Evaluation of Pain and Functional Performance Determined by the Harris Hip Score(3 years postoperatively, due to early study termination)
- Confirmation of Safety Based on Complications(3 years postoperatively, due to early study termination)