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CompletedNCT02829866Updated Mar 17, 2023

AMIStem-H Radiographic Analysis

An observational study in Arthroplasty, Replacement and Hip, sponsored by Medacta International SA. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-17.

Sponsored by Medacta International SA · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
289
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Arthroplasty
  • Replacement
  • Hip
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In context

Lead sponsor

Medacta International SA is the lead sponsor of 46 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
289 participants (actual)
Patient registry
No

Interventions

  • DeviceAMIStem-H
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What researchers measure

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

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Study locations

1 site
  • Kantonspital Winthertur
    Winterthur, 8400, Switzerland
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02829866
Lead sponsor
Medacta International SA
Responsible party
Sponsor
First posted
Jul 12, 2016
Start date
Sep 2010
Primary completion
Sep 2021
Completion
Oct 2021
Last update
Mar 17, 2023
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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