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Completed

NCT Number: NCT02829866

AMIStem-H Radiographic Analysis

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.

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Key information

Conditions

Arthroplasty Hip Replacement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kantonspital Winthertur

Winterthur, 8400, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Minor patient
  • Pregnant or breast feeding woman
  • Any patient who cannot or will not provide informed consent for participation in the study

Treatment and study plan

AMIStem-H

Device

Primary outcomes

  1. Radiological analysis of radiolucency lines presence according to Gruen zone classification

    Time frame: 5 year

Secondary outcomes

  1. radiological assessment of femoral deformation

    Time frame: 5 year, 10 year

  2. radiological assessment of femoral stem subsidence

    Time frame: 5 year, 10 year

  3. radiological assessment of cortical bone density

    Time frame: 5 year, 10 year

  4. radiological assessment of calcar resorption

    Time frame: 5 year, 10 year

  5. Radiological analysis of radiolucency lines presence according to Gruen zone classification

    Time frame: 10 year

Sponsors and collaborators

Lead sponsor

Medacta International SA

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2021
Study completion
2021
First posted
Jul 12, 2016
Registry last updated
Mar 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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