Primary OsteoarthritisNCT06012656
Prospective Study for the Evaluation of the Cementless Anatomic Femoral Stem Minimax -Launay
An observational study of Primary Osteoarthritis and Secondary Osteoarthritis, run by Medacta International SA at 1 site in France.
Trial summary
This is a post-marketing surveillance on MiniMAX Stem Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Osteoarthritis, Secondary Osteoarthritis, Traumatic Arthritis
- What is being tested?
- MiniMAX
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2019to 2 Jan 2031
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The sample size of 100 patients has been defined based on the literature data to guarantee a sufficient number of patients for the evaluation of the performance of the prosthesis, taking into account a 10% of lost patients (dead or lost at follow-up).
Who may be able to join
- Patient with a clinical condition requiring THA
- Patient receiving a MiniMAX® stem
- Patient aged more than 18 years
- Patient having a Social Insurance or a similar protection regime
- Patient eligible for an AMIS procedure
- Patient able to follow the study requirements
- Patients who are willing to give informed written consent
Who cannot join
- Patient with local or systemic infection
- Participation to biomedical research
- Patient whose BMI exceeds 40
- Patient with less than 18 years
- Protected adults
- Vulnerable person according to article L1121-6 of the Code de la Santè Publique.
- Pregnant or lactating woman
- Patient unable to express his/ her opinion about the participation to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Multricentre, Non Controlled, Non-randomized, Open Study for the Evaluation of the Cementless Anatomic Femoral Stem MiniMAX
This is a post-marketing surveillance on MiniMAX Stem
- Conditions
- Primary Osteoarthritis, Secondary Osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis, Congenital Hip Dysplasia, Avascular Necrosis
- Being tested
- MiniMAX
- Medical subject headings
- Arthritis, Rheumatoid, Hip Dislocation, Congenital, Osteonecrosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiniMAXDevice
Total or Partial Hip Arthroplasty
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 (6)
Functional evaluation
Harris Hip Score (HHS): the HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
Measured: Pre-op, 3 months, 1, 3, 5, 10 years
Evaluation of patient satisfaction
HOOS (hip disability and osteoarthritis outcome score) questionnaire: HOOS is a questionnaire intended to be used to assess patient's opinion about their hip and associated problems, and to evaluate their symptoms and functional limitations during a therapeutic process.The interval score ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health.
Measured: Pre-op, 3 months, 1, 3, 5, 10 years
Evaluation of the stem fixation
Radiographic evaluation to assess the osteointegration of the stem, the implant positioning, radiolucent lines.
Measured: Pre-op, 3 months, 1, 3, 5, 10 years
Evaluation of the general and thigh pain
Echelle Visuelle Analogique (EVA) and pain location. Interpretation of the EVA scale: no pain 0, low pain 1-3, moderate pain 4-6, severe pain 7-9, extreme pain 10.
Measured: Pre-op, 3 months, 1, 3, 5, 10 years
Incidence of adverse events
Intraoperative and postoperative complications
Measured: Surgery, Immediate post-op, 3 months, 1, 3, 5, 10 years
Evaluation of the stability of the stem
Radiographic evaluation to assess the osteointegration of the stem, the implant positioning, radiolucent lines.
Measured: Pre-op, 3 months, 1, 3, 5, 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start2 Jan 2019
- Primary completion2 Jan 2029 (estimated)
- Study completion2 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary OsteoarthritisStudies 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
- 100 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
- NCT06012656
- Sponsor's protocol ID
- P01.005.10
- Status last verified
- Sep 2026
- First submitted
- 26 Jul 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multricentre, Non Controlled, Non-randomized, Open Study for the Evaluation of the Cementless Anatomic Femoral Stem MiniMAX
- ClinicalTrials.gov ID
- NCT06012656
- Acronym / sponsor ID
- P01.005.10
- Conditions
- Primary Osteoarthritis, Secondary Osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis, Congenital Hip Dysplasia, Avascular Necrosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 2 Jan 2029 (estimated)
- Study completion
- 2 Jan 2031 (estimated)
- First posted
- 25 Aug 2023 (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-marketing surveillance on MiniMAX Stem
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sample size of 100 patients has been defined based on the literature data to guarantee a sufficient number of patients for the evaluation of the performance of the prosthesis, taking into account a 10% of lost patients (dead or lost at follow-up).
Key inclusion criteria (7 listed)
- Patient with a clinical condition requiring THA
- Patient receiving a MiniMAX® stem
- Patient aged more than 18 years
- Patient having a Social Insurance or a similar protection regime
- Patient eligible for an AMIS procedure
Key exclusion criteria (8 listed)
- Patient with local or systemic infection
- Participation to biomedical research
- Patient whose BMI exceeds 40
- Patient with less than 18 years
- Protected adults
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 |
|---|---|---|
| MiniMAXTotal or Partial Hip Arthroplasty | Device | – |
Primary outcome
Survival Rate
Time frame: 10 years
Kaplan Meier method
6 secondary outcomes
Functional evaluation
Time frame: Pre-op, 3 months, 1, 3, 5, 10 years
Evaluation of patient satisfaction
Time frame: Pre-op, 3 months, 1, 3, 5, 10 years
Evaluation of the stem fixation
Time frame: Pre-op, 3 months, 1, 3, 5, 10 years
Evaluation of the general and thigh pain
Time frame: Pre-op, 3 months, 1, 3, 5, 10 years
Incidence of adverse events
Time frame: Surgery, Immediate post-op, 3 months, 1, 3, 5, 10 years
Evaluation of the stability of the stem
Time frame: Pre-op, 3 months, 1, 3, 5, 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 Oct 2026.
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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 Primary Osteoarthritis and Secondary Osteoarthritis, run by Medacta International SA at 1 site 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 7 inclusion and 8 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 Oct 2026. 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 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 Oct 2026.