AMIStem-H Radiographic Analysis

Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02829866
• Other study ID #: P01.001.11
• Status: Completed
• Start date: September 2010
• Est. completion date: October 2021

Study information

• Verified date: October 2021
• Source: Medacta International SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: October 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty
• Hip
• Replacement

Intervention

Device:
• AMIStem-H

Locations

Country	Name	City	State
Switzerland	Kantonspital Winthertur	Winterthur

Sponsors (1)

Lead Sponsor	Collaborator
Medacta International SA

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiological analysis of radiolucency lines presence according to Gruen zone classification		5 year
Secondary	radiological assessment of femoral deformation		5 year, 10 year
Secondary	radiological assessment of femoral stem subsidence		5 year, 10 year
Secondary	radiological assessment of cortical bone density		5 year, 10 year
Secondary	radiological assessment of calcar resorption		5 year, 10 year
Secondary	Radiological analysis of radiolucency lines presence according to Gruen zone classification		10 year