THP AMIStem-H: Open, Retrospective and Prospective, Monocentric, Non Randomised Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medacta International SA
- Enrollment
- 289
- Locations
- 1
- Primary Endpoint
- Radiological analysis of radiolucency lines presence according to Gruen zone classification
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient who has received a total hip arthroplasty between January 2010 and December 2011
- •Patient who has received an AMIStem H femoral component
- •Patient who have signed the information letter in order to give agreement for the clinical data treatment
Exclusion Criteria
- •Minor patient
- •Pregnant or breast feeding woman
- •Any patient who cannot or will not provide informed consent for participation in the study
Outcomes
Primary Outcomes
Radiological analysis of radiolucency lines presence according to Gruen zone classification
Time Frame: 5 year
Secondary Outcomes
- radiological assessment of femoral deformation(5 year, 10 year)
- radiological assessment of femoral stem subsidence(5 year, 10 year)
- radiological assessment of cortical bone density(5 year, 10 year)
- radiological assessment of calcar resorption(5 year, 10 year)
- Radiological analysis of radiolucency lines presence according to Gruen zone classification(10 year)