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
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.
- 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