Arthritis, Avascular Necrosis, Congenital Hip Dysplasia, Fracture of the Femoral Neck or Head, Osteoarthritis
Conditions
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.
Interventions
DEVICEMpact Acetabular Shell
Total Hip Replacement
Sponsors
Medacta International SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Kaplan-Meier analysis as a measure of implant performance. | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| The Harris Hip Score. | pre-op, 3/6 months, 1,2 and 5 years |
| Radiological analysis as a meausure of safety. | 3/6 months, 1,2 and 5 years |
Countries
United States
Outcome results
None listed