Multicentre SMS Study - FR

NCT ID: NCT06640764

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 260 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2037-09-01

Brief Summary

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Total Hip Arthroplasty

Total Hip Arthroplasty with SMS Femoral Stem (Medacta)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medacta International SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique de l'Union

Saint-Jean, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Paul Maisongrosse

Role: CONTACT

paul.maisongrosse@hotmail.fr

0033 05 61 37 85 93

Facility Contacts

Paul Maisongrosse

Role: primary

paul.maisongrosse@hotmail.fr

0033 05 61 37 85 93

Other Identifiers

P01.019.07

Identifier Type: -

Identifier Source: org_study_id