Actively Recruiting
Prospective Multicenter Open Study Evaluating Performance and Stability of the SMS Cementless Femoral Stem Implant
Led by Medacta International SA · Updated on 2024-10-15
260
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the performance and stability of the SMS femoral stem implant in patients who need total hip replacement due to conditions like osteoarthritis, traumatic arthritis, developmental dysplasia of the hip, or avascular necrosis of the femoral head. This is a prospective, multicenter, open clinical study without randomization or control groups. The study is sponsored by Medacta International SA and aims to observe participants for up to 10 years to assess long-term outcomes. Participants will undergo Total Hip Arthroplasty using the SMS Femoral Stem by Medacta. The study will monitor the implant's survival rate, clinical performance, hip function, quality of life, safety through adverse event tracking, and the implant's stability and fixation over the 10-year period. There is no mention of different treatment groups or placebos, as this is an observational study focused on one specific implant procedure. During the study, participants will be regularly assessed for the durability and function of the SMS femoral stem, hip joint performance, and overall quality of life. Safety will be monitored by recording any adverse events. The total participation duration lasts from enrollment until 10 years after the procedure. Patients must comply with study requirements and provide informed consent, with ongoing follow-up to evaluate the implant's long-term effects and stability.
CONDITIONS
Brief Title
Multicentre SMS Study - FR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has a severely painful or disabling hip joint due to osteoarthritis, traumatic arthritis, developmental dysplasia of the hip, or avascular necrosis of the femoral head requiring total hip replacement
- Patient will receive a Medacta SMS femoral stem implant
- Patient agrees to follow study requirements
- Patient has signed the consent form
- Patient is affiliated with a social security system
- Patient is aged between 18 and 75 years
You will not qualify if you...
- Participating in other biomedical research
- Minor patient
- Protected adult patient
- Vulnerable individuals as defined by law
- Pregnant or breastfeeding women
- Unable to express non-opposition
- Refusal to allow collection of personal data
- Acute, systemic, or chronic infection
- Skeletal immaturity
- Grossly deformed anatomy as determined by the surgeon
- Osteomalacia contraindicating uncemented implant fixation
- Active rheumatoid arthritis or osteoporosis
- Metabolic disorders impairing bone formation contraindicating uncemented implant fixation
- Muscle atrophy or neuromuscular disease
- Allergy to implant material
- Inability or unwillingness to give informed consent
- Medical problems compromising independent mobility
- Any contraindication listed in the implant's instructions for use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks or until discharge
Participants undergo Total Hip Arthroplasty with the SMS Femoral Stem implant and receive immediate post-operative care.
1 surgery visit and several immediate post-operative visits
Duration - Up to 10 years
Participants are followed to evaluate hip function, implant stability, quality of life, and safety of the SMS femoral stem over time.
Regular follow-up visits as scheduled over 10 years
Trial Site Locations
Total: 1 location
1
Clinique de l'Union
Saint-Jean, France, 31240
Actively Recruiting
Research Team
P
Paul Maisongrosse
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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