OsteoarthritisArthritisAvascular NecrosisFracture of the Femoral Neck or HeadCongenital Hip Dysplasia
Investigational drug(s) / intervention(s)
AMIStem Hip System
Study summary
This is a multicentre post-marketing prospective study to evaluate performance and clinical outcomes of AMIIStem primary hip system.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patient is a good candidate for a primary hip arthroplasty using AMIStem Hip System
* Patient is willing and able to give informed consent to participate in the follow-up program
* Patient is suitable for surgery and able to participate in the follow-up program.
* Those presenting with disease that meets the indication for use for Medacta implants defined in the study (on-label use)
Exclusion Criteria:
* Acute systemic or chronic infection
* Skeletal immaturity
* Severe muscular, neurological, vascular deficiency or other pathologies of the affected limb that may compromise the stability of the implant.
* Bone condition that may compromise the stability of the implant.
* Patient who are unwilling or unable to give consent, or to comply with the protocol and the follow-up program.
Primary outcome measure(s)
Assessment of implant survivorship using Kaplan Meier curve — 10 years after surgery
Trial sites (2)
Facility
City
Region
Status
Uniklinik Balgrist
Zurich
Switzerland
The Elective Orthopaedic Centre (EOC)
Epsom
Surrey
More Medacta International SA trials in Switzerland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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