AMIStem-H Radiographic Analysis

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

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 Overview

• Status: Completed
• Conditions: Arthroplasty; Hip; Replacement
• Intervention / Treatment: Device: AMIStem-H

• Study Type: Observational
• Enrollment (Actual): 289

Contacts and Locations

Study Locations

• Switzerland
  • Winterthur, Switzerland, 8400
    • Kantonspital Winthertur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Radiological analysis of radiolucency lines presence according to Gruen zone classification	5 year

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Medacta International SA

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2010
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: July 5, 2016
• First Submitted That Met QC Criteria: July 7, 2016
• First Posted (Estimate): July 12, 2016

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: P01.001.11