ArthrosisNCT04997005
The Medacta International AMIStem-P Post-Marketing Surveillance Study
An observational study of Arthrosis and Traumatic Arthritis, run by Medacta International SA at 5 sites in France.
Trial summary
This is a Post-Market Surveillance study of AMIStem-P femoral stem prosthesis Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Arthrosis, Traumatic Arthritis, Rheumatoid Polyarthritis
- What is being tested?
- AMIStem-P
- Type of treatment
- Medical device
- How many people
- 550 participants
- Where
- 5 sitesFrance
- Study dates
- 26 Apr 2019to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring Total Hip Arthroplasty and who are suitable to receive Medacta AMIStem-P femoral stem will be proposed to take part to the current post-market surveillance study during their pre-operative visit.
Who may be able to join
- Patients with a disease (primary coxarthrosis, inflammatory arthritis of the hip, necrosis of the femoral head, etc.) requiring a total hip replacement
- Patient eligible to receive an uncemented AMIStem-P femoral stem
- Patient agreeing to comply with the study requirements
- Patient willing to provide written informed consent
- Patient affiliated to a social security system
- Patients between 18 and 85 years old
Who cannot join
- Participation in biomedical research
- Patients younger than 18 years old
- Vulnerable adult patients according to article L1121-6 of the French Public Health Code
- Pregnant or breastfeeding women
- Patients unable to provide written informed consent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Clinique de Saint Omer
Blendecques, 62575
Hôpital Castres
Castres, 81108
Nouvelle Clinique Bordeaux Tondu
Floirac, 33270
Clinique d'Orange
Orange, 84100
Hôpital Jacques-Puel
Rodez, 12000
About this study
Official title: Prospective, Multicentre, Open Study Evaluating the Performance and Stability of the AMIStem-P Femoral Stem
This is a Post-Market Surveillance study of AMIStem-P femoral stem prosthesis
- Conditions
- Arthrosis, Traumatic Arthritis, Rheumatoid Polyarthritis, Congenital Hip Dysplasia, Avascular Necrosis of the Femoral Head
- Being tested
- AMIStem-P
- Medical subject headings
- Osteoarthritis, Hip Dislocation, Congenital, Femur Head Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMIStem-PDevice
Performance of Total Hip Arthroplasty (THA) with AMIStem-P femoral stem implant
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Kaplan Meier method
Measured: 10 years
Secondary outcomes (5)
Harris Hip Score
Harris Hip Score [min = 0 (worst clinical outcome), max = 100 (best clinical outcome)]
Measured: 3/6 months, 1, 3, 5 and 10 years
Oxford Hip Score
Oxford Hip Score [min = 0 (worst functional outcome), max = 48 (best functional outcome)]
Measured: 3/6 months, 1, 3, 5 and 10 years
Radiographic performance of the implants
Presence of radiolucencies, migration, loosening, subsidence, tilt
Measured: 3/6 months, 1, 3, 5 and 10 years
Quality of life - Euroqol questionnaire
EQ-5D-5L score [min = -0.59 (worst functional outcome), max = 1 (best functional outcome)]
Measured: 3/6 months, 1, 3, 5 and 10 years
Adverse events
Intraoperative and postoperative adverse events
Measured: intraop, 3/6 months, 1, 3, 5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start26 Apr 2019
- Primary completion30 Apr 2029 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthrosisStudies of the same condition, open and under way.
- More trials run by Medacta International SAThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexandru Nebunescu-Schirliu, MD, Principal investigator, Hôpital Jacques-Puel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997005
- Sponsor's protocol ID
- P01.001.16
- Status last verified
- May 2025
- First submitted
- 4 Aug 2021
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentre, Open Study Evaluating the Performance and Stability of the AMIStem-P Femoral Stem
- ClinicalTrials.gov ID
- NCT04997005
- Acronym / sponsor ID
- P01.001.16
- Conditions
- Arthrosis, Traumatic Arthritis, Rheumatoid Polyarthritis, Congenital Hip Dysplasia, Avascular Necrosis of the Femoral Head
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 9 Aug 2021 (actual)
- 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.
This is a Post-Market Surveillance study of AMIStem-P femoral stem prosthesis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring Total Hip Arthroplasty and who are suitable to receive Medacta AMIStem-P femoral stem will be proposed to take part to the current post-market surveillance study during their pre-operative visit.
Key inclusion criteria (6 listed)
- Patients with a disease (primary coxarthrosis, inflammatory arthritis of the hip, necrosis of the femoral head, etc.) requiring a total hip replacement
- Patient eligible to receive an uncemented AMIStem-P femoral stem
- Patient agreeing to comply with the study requirements
- Patient willing to provide written informed consent
- Patient affiliated to a social security system
Key exclusion criteria (5 listed)
- Participation in biomedical research
- Patients younger than 18 years old
- Vulnerable adult patients according to article L1121-6 of the French Public Health Code
- Pregnant or breastfeeding women
- Patients unable to provide written informed consent
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-PPerformance of Total Hip Arthroplasty (THA) with AMIStem-P femoral stem implant | Device | – |
Primary outcome
Survival rate
Time frame: 10 years
Kaplan Meier method
5 secondary outcomes
Harris Hip Score
Time frame: 3/6 months, 1, 3, 5 and 10 years
Oxford Hip Score
Time frame: 3/6 months, 1, 3, 5 and 10 years
Radiographic performance of the implants
Time frame: 3/6 months, 1, 3, 5 and 10 years
Quality of life - Euroqol questionnaire
Time frame: 3/6 months, 1, 3, 5 and 10 years
Adverse events
Time frame: intraop, 3/6 months, 1, 3, 5 and 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
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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.
Alexandru Nebunescu-Schirliu, MD principal investigator
Hôpital Jacques-Puel
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthrosis and Traumatic Arthritis, run by Medacta International SA at 5 sites in France.
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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
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?
Survival rate (time frame: 10 years). 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 8 May 2025.