AMIStem-H Radiographic Analysis
THP AMIStem-H: Open, Retrospective and Prospective, Monocentric, Non Randomised Observational Study
1 other identifier
observational
289
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 5, 2016
CompletedFirst Posted
Study publicly available on registry
July 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedMarch 17, 2023
October 1, 2021
11 years
July 5, 2016
March 16, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Radiological analysis of radiolucency lines presence according to Gruen zone classification
5 year
Secondary Outcomes (5)
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
Interventions
Eligibility Criteria
Patients who received a total hip arthroplasty with AMIStem H between January 2010 and December 2011 will be invited to participate in the study during the visit at 5 years previewed by standard practice.
You may qualify if:
- 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
You may not qualify if:
- Minor patient
- Pregnant or breast feeding woman
- Any patient who cannot or will not provide informed consent for participation in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kantonspital Winthertur
Winterthur, 8400, Switzerland
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2016
First Posted
July 12, 2016
Study Start
September 1, 2010
Primary Completion
September 1, 2021
Study Completion
October 1, 2021
Last Updated
March 17, 2023
Record last verified: 2021-10