AMIStem-H Radiographic Analysis

Completed

• Conditions: Hip; Arthroplasty; Replacement

• Registration Number: NCT02829866
• Lead Sponsor: Medacta International SA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2016-07-05
• Study First Submitted QC: 2016-07-07
• Study First Posted: 2016-07-12
• Primary Completion: 2021-09
• Status Verified: 2021-10
• Study Completion: 2021-10
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 289

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiological analysis of radiolucency lines presence according to Gruen zone classification	5 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kantonspital Winthertur; 🇨🇭 Winterthur, Switzerland