NCT02829866

AMIStem-H Radiographic Analysis

THP AMIStem-H: Open, Retrospective and Prospective, Monocentric, Non Randomised Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 289 (actual)
• Sponsor: Medacta International SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Total hip replacement (THP) is widely used for hip osteoarthritis treatment. Surgeons are constantly looking to improve all aspects related to this procedure weather is improvement of implant design, instrumentation or surgical technique. Excellent clinical and radiological results were observed at medium and long term in the last years for AMIStem system. This observational study has the objective to survey hip prosthesis stability and function of the operated hip in patients who are not exposed to surgical risks. The principal investigator will contact all patients in order to perform the follow-up visit according to standard practice. Patients operated between January 2010 and December 2011 will be invited in the study during the clinical visit organised according to standard practice. Preoperative clinical and radiological data, intraoperative details and postoperative follow-up data at 1-year will be retrospectively collected. Five-year and ten-year data will be prospectively collected after inclusion in the study.

Conditions

• Arthroplasty
• Replacement
• Hip

Interventions

Type	Name	Description
DEVICE	AMIStem-H

Timeline

• Start date: 2010-09-01
• Primary completion: 2021-09-01
• Completion: 2021-10-01
• First posted: 2016-07-12
• Last updated: 2023-03-17

Locations

1 site across 1 country: Switzerland