NCT02196818
Terminated
Not Applicable
A Multi-centre, Prospective Post Marketing Surveillance Study to Assess Mid-term Performance of the Mpact Cup in Subjects Requiring Primary Total Hip Arthroplasty
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- Medacta International SA
- Enrollment
- 200
- Locations
- 4
- Primary Endpoint
- The Kaplan-Meier analysis as a measure of implant performance.
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a multi-centre, prospective post marketing surveillance study to assess mid-term performance of the Mpact cup in subjects requiring primary total hip arthroplasty.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.
- •Those presenting with disease that meets the indications for use for Medacta USA implants defined by this study (on-label use).
- •Patients must be willing to comply with the pre and post-operative evaluation schedule.
Exclusion Criteria
- •Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study.
Outcomes
Primary Outcomes
The Kaplan-Meier analysis as a measure of implant performance.
Time Frame: 5 years
Secondary Outcomes
- Radiological analysis as a meausure of safety.(3/6 months, 1,2 and 5 years)
- The Harris Hip Score.(pre-op, 3/6 months, 1,2 and 5 years)
Study Sites (4)
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