Dysplasia of Hip JointNCT06640764
Multicentre SMS Study - FR
An observational study of Dysplasia of Hip Joint and Hip Osteoarthritis, run by Medacta International SA at 1 site in France.
Trial summary
Prospective, multicentre, non controled, non randomised, clinical study to assess the performance and the stability of SMS femoral stem Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Dysplasia of Hip Joint, Hip Osteoarthritis, Traumatic Arthritis of Hip
- What is being tested?
- Total Hip Arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2024to 1 Sep 2037
- 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 suffering from a severely painful and/or disabling hip joint (osteoarthritis, traumatic arthritis, developmental dysplasia of the hip, avascular necrosis of the femoral head) requiring a total hip prosthesis and who will receive a Medacta SMS femoral stem. Patients will be able to participate in other non-interventional research for the duration of the study.
Who may be able to join
- Patient suffering from a severely painful and/or disabling hip joint due to osteoarthritis, traumatic arthritis, developmental dysplasia of the hip, or avascular necrosis of the femoral head, and requiring a total hip replacement.
- Patient who will receive a Medacta SMS femoral stem.
- Patient agrees to comply with the study requirements.
- Patient has signed the consent form.
- Patient is affiliated with a social security system.
- Patient aged 18 to 75 years
Who cannot join
- Participation in biomedical research.
- Minor patient.
- Protected adult patient.
- Vulnerable individuals as defined by Article L1121-6 of the Public Health Code.
- Pregnant or breastfeeding women.
- Patient unable to express their non-opposition.
Show all 17Show fewer
- Patient refusing the collection of their personal data.
- Acute, systemic, or chronic infection. Skeletal immaturity.
- Grossly deformed anatomy (at the surgeon's discretion).
- Osteomalacia for which the fixation of an uncemented implant is contraindicated.
- Patient suffering from active rheumatoid arthritis or osteoporosis.
- Patient with metabolic disorders likely to impair bone formation when the fixation of an uncemented implant is contraindicated.
- Patient suffering from muscle atrophy or neuromuscular disease.
- Patient with an allergy to the implant material.
- Any patient who cannot or does not wish to give their informed consent to participate in the study.
- Patient whose prospects of regaining independent mobility would be compromised by known coexisting medical problems.
- Any contraindication mentioned in the instructions for use of the investigational medical device.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique de l'Union
Saint-Jean, 31240
Paul Maisongrosse, 0033 05 61 37 85 93, paul.maisongrosse@hotmail.fr
About this study
Official title: Étude Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte évaluant la Performance et la stabilité de l'Implant fémoral Non cimenté SMS
Prospective, multicentre, non controled, non randomised, clinical study to assess the performance and the stability of SMS femoral stem
- Conditions
- Dysplasia of Hip Joint, Hip Osteoarthritis, Traumatic Arthritis of Hip, Avascular Necrosis of Femur Head
- Being tested
- Total Hip Arthroplasty
- Medical subject headings
- Osteoarthritis, Hip, Femur Head Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ArthroplastyProcedure or surgery
Total Hip Arthroplasty with SMS Femoral Stem (Medacta)
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate of SMS femoral stem
Survival analysis accordin to the Kaplan-Meier method
Measured: From enrollment to the end of treatment at 10 years
Secondary outcomes (5)
Evaluation of the clinical performance of the SMS femoral stem
Clinical performance of the SMS femoral stem evaluated through the Harris Hip Score. The Harris Hip Score is a standardized measure used to assess the severity of hip pain and functional limitations in individuals with hip conditions. 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: From enrollment to the end of treatment at 10 years
Evaluation of the hip function
Hip function evaluated through the Oxford Hip Score. The Oxford Hip Score (OHS) is a short 12-item patient-reported PRO specifically designed and developed to assess function and pain with patients undergoing hip replacement surgery. The total gives a minimum score of 12 and a maximum of 60. A higher score implies a greater degree of disability.
Measured: From enrollment to the end of treatment at 10 years
Evaluation of the quality of life
Quality of life evaluated through the EuroQol Score (EQ-5D-5L). The EQ-5D family of instruments has been developed to describe and value health across a wide range of disease areas. Each EQ-5D instrument comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS) that are cognitively undemanding, taking only a few minutes to complete. The questionnaire provides a simple descriptive profile of a respondent's health state. The EQ VAS provides an alternative way to elicit an individual's rating of their own overall current health
Measured: From enrollment to the end of treatment at 10 years
Evaluation of the safety (adverse events) of the SMS femoral stem
Safety of the SMS femoral stem evaluated through the collection of the intraoperative and postoperative complications
Measured: From enrollment to the end of treatment at 10 years
Evaluation of the stability and the fixation of the SMS femoral stem
Stability and fixation of the SMS femoral stem evaluated through the radiographic anaysis, assessing the position of the implant (subsidence and migration), the presence of radiolucent lines, the implant breakage.
Measured: From enrollment to the end of treatment at 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Sep 2024
- Primary completion1 Sep 2034 (estimated)
- Study completion1 Sep 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysplasia of Hip JointStudies 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
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640764
- Sponsor's protocol ID
- P01.019.07
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2024
- Last updated
- 8 Oct 2026
- Results posted
- 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
- Étude Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte évaluant la Performance et la stabilité de l'Implant fémoral Non cimenté SMS
- ClinicalTrials.gov ID
- NCT06640764
- Acronym / sponsor ID
- P01.019.07
- Conditions
- Dysplasia of Hip Joint, Hip Osteoarthritis, Traumatic Arthritis of Hip, Avascular Necrosis of Femur Head
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2034 (estimated)
- Study completion
- 1 Sep 2037 (estimated)
- First posted
- 15 Oct 2024 (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.
Prospective, multicentre, non controled, non randomised, clinical study to assess the performance and the stability of SMS femoral stem
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 suffering from a severely painful and/or disabling hip joint (osteoarthritis, traumatic arthritis, developmental dysplasia of the hip, avascular necrosis of the femoral head) requiring a total hip prosthesis and who will receive a Medacta SMS femoral stem. Patients will be able to participate in other non-interventional research for the duration of the study.
Key inclusion criteria (6 listed)
- Patient suffering from a severely painful and/or disabling hip joint due to osteoarthritis, traumatic arthritis, developmental dysplasia of the hip, or avascular necrosis of the femoral head, and requiring a total hip replacement.
- Patient who will receive a Medacta SMS femoral stem.
- Patient agrees to comply with the study requirements.
- Patient has signed the consent form.
- Patient is affiliated with a social security system.
Key exclusion criteria (17 listed)
- Participation in biomedical research.
- Minor patient.
- Protected adult patient.
- Vulnerable individuals as defined by Article L1121-6 of the Public Health Code.
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| Total Hip ArthroplastyTotal Hip Arthroplasty with SMS Femoral Stem (Medacta) | Procedure or surgery | – |
Primary outcome
Survival rate of SMS femoral stem
Time frame: From enrollment to the end of treatment at 10 years
Survival analysis accordin to the Kaplan-Meier method
5 secondary outcomes
Evaluation of the clinical performance of the SMS femoral stem
Time frame: From enrollment to the end of treatment at 10 years
Evaluation of the hip function
Time frame: From enrollment to the end of treatment at 10 years
Evaluation of the quality of life
Time frame: From enrollment to the end of treatment at 10 years
Evaluation of the safety (adverse events) of the SMS femoral stem
Time frame: From enrollment to the end of treatment at 10 years
Evaluation of the stability and the fixation of the SMS femoral stem
Time frame: From enrollment to the end of treatment at 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.
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 Dysplasia of Hip Joint and Hip 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 6 inclusion and 17 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: looking for participants now, 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?
Contact Paul Maisongrosse (0033 05 61 37 85 93, paul.maisongrosse@hotmail.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate of SMS femoral stem (time frame: From enrollment to the end of treatment at 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.