Arthroplasty, Hip, Replacement
Conditions
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.
Interventions
DEVICEAMIStem-H
Sponsors
Medacta International SA
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient who has received a total hip arthroplasty between January 2010 and December 2011 2. Patient who has received an AMIStem H femoral component 3. Patient who have signed the information letter in order to give agreement for the clinical data treatment
Exclusion criteria
1. Minor patient 2. Pregnant or breast feeding woman 3. Any patient who cannot or will not provide informed consent for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiological analysis of radiolucency lines presence according to Gruen zone classification | 5 year |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Switzerland
Outcome results
None listed