Multicentre SMS Study - FR

NCT06640764 | Recruiting

• 1 other identifier: P01.019.07
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Survival rate of SMS femoral stem

  Survival analysis accordin to the Kaplan-Meier method

  From enrollment to the end of treatment at 10 years

Secondary Outcomes (5)

• Evaluation of the clinical performance of the SMS femoral stem

  From enrollment to the end of treatment at 10 years

• Evaluation of the hip function

  From enrollment to the end of treatment at 10 years

• Evaluation of the quality of life

  From enrollment to the end of treatment at 10 years

• Evaluation of the safety (adverse events) of the SMS femoral stem

  From enrollment to the end of treatment at 10 years

• Evaluation of the stability and the fixation of the SMS femoral stem

  From enrollment to the end of treatment at 10 years

Interventions

Total Hip Arthroplasty PROCEDURE

Total Hip Arthroplasty with SMS Femoral Stem (Medacta)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medacta International SA: lead

Study Sites (1)

Clinique de l'Union

Saint-Jean, 31240, France

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip; Femur Head Necrosis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Osteonecrosis; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Central Study Contacts

Paul Maisongrosse

CONTACT

0033 05 61 37 85 93; paul.maisongrosse@hotmail.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2034
• Study Completion (Estimated): September 1, 2037
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

FR (1)