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
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.
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- 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