ArthroplastyNCT02829866
AMIStem-H Radiographic Analysis
An observational study of Arthroplasty and Replacement, run by Medacta International SA at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- AMIStem-H
- Type of treatment
- Medical device
- How many people
- 289 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2010to Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Minor patient
- Pregnant or breast feeding woman
- Any patient who cannot or will not provide informed consent for participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- AMIStem-H
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMIStem-HDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological analysis of radiolucency lines presence according to Gruen zone classification
Measured: 5 year
Secondary outcomes (5)
radiological assessment of femoral deformation
Measured: 5 year, 10 year
radiological assessment of femoral stem subsidence
Measured: 5 year, 10 year
radiological assessment of cortical bone density
Measured: 5 year, 10 year
radiological assessment of calcar resorption
Measured: 5 year, 10 year
Radiological analysis of radiolucency lines presence according to Gruen zone classification
Measured: 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startSep 2010
- Primary completionSep 2021
- Study completionOct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829866
- Sponsor's protocol ID
- P01.001.11
- Status last verified
- Oct 2021
- First submitted
- 5 Jul 2016
- Last updated
- 17 Mar 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THP AMIStem-H: Open, Retrospective and Prospective, Monocentric, Non Randomised Observational Study
- ClinicalTrials.gov ID
- NCT02829866
- Acronym / sponsor ID
- P01.001.11
- Conditions
- Arthroplasty, Replacement, Hip
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- Sep 2010 (actual)
- Primary completion
- Sep 2021 (actual)
- Study completion
- Oct 2021 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Minor patient
- Pregnant or breast feeding woman
- Any patient who cannot or will not provide informed consent for participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMIStem-H | Device | – |
Primary outcome
Radiological analysis of radiolucency lines presence according to Gruen zone classification
Time frame: 5 year
5 secondary outcomes
radiological assessment of femoral deformation
Time frame: 5 year, 10 year
radiological assessment of femoral stem subsidence
Time frame: 5 year, 10 year
radiological assessment of cortical bone density
Time frame: 5 year, 10 year
radiological assessment of calcar resorption
Time frame: 5 year, 10 year
Radiological analysis of radiolucency lines presence according to Gruen zone classification
Time frame: 10 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty and Replacement, run by Medacta International SA at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological analysis of radiolucency lines presence according to Gruen zone classification (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.