A Multi-centre, Prospective Surveillance to Assess Mid-term Performance of the Mpact Cup
Terminated
- Conditions
- OsteoarthritisArthritisFracture of the Femoral Neck or HeadAvascular NecrosisCongenital Hip Dysplasia
- Registration Number
- NCT02196818
- Lead Sponsor
- Medacta International SA
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 200
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Kaplan-Meier analysis as a measure of implant performance. 5 years
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (4)
Vail Orthopedics, P.C.
🇺🇸Denver, Colorado, United States
Saint Alphonsus Regional Medical Center
🇺🇸Boise, Idaho, United States
Illinois Bone & Joint Institute, LLC
🇺🇸Libertyville, Illinois, United States
Jordan Valley Medical Center
🇺🇸West Jordan, Utah, United States
Vail Orthopedics, P.C.🇺🇸Denver, Colorado, United States