The Medacta International SMS Post-Marketing Surveillance Study

Launched by MEDACTA INTERNATIONAL SA · Apr 21, 2016

Keywords

ClinConnect Summary

The Medacta International SMS Post-Marketing Surveillance Study is looking at a specific type of hip implant called the SMS femoral stem prosthesis. This study aims to gather information about how well this implant works for people suffering from severe hip pain due to conditions like arthritis (both osteoarthritis and traumatic arthritis), congenital hip dysplasia, or avascular necrosis, which is a condition where blood supply to the hip bone is reduced, causing pain and damage. The trial is currently recruiting participants aged 18 to 75 who are scheduled for a total hip replacement surgery.

If you decide to participate in this study, you will help researchers understand the long-term performance of the SMS implant over a 10-year period. It’s important to note that certain individuals may not be eligible, such as those with active infections, severe mental health issues, or specific medical conditions that could affect their recovery. If you qualify, you can expect regular follow-up appointments to track your progress and ensure the implant is working well for you. This study is a valuable opportunity to contribute to medical knowledge while potentially improving your own health outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Individuals with a severely painful and/or disabling hip joint with osteoarthritis, traumatic arthritis or developmental dysplasia of the hip or avascular necrosis of the femoral head.
• • In order to take part in this study, all study participants must be between the ages of 18 and 75 years of age, at the time of surgery.
• • Scheduled for a primary total hip replacement.
• Exclusion Criteria:
• • Active infection
• • Pregnancy
• • Mental illness where the known condition is likely to compromise the patient's ability to consent, affect the patient's assessment of their progress or complete the 10 year cycle of follow-up appointments and reviews
• • Grossly distorted anatomy (surgeon's discretion)
• • Osteomalacia where uncemented implant fixation is contraindicated
• • Active rheumatoid arthritis.
• • Osteoporosis
• • Metabolic disorders which may impair bone formation where uncemented implant fixation is contraindicated
• • Muscular atrophy or neuromuscular disease
• • Allergy to implant material
• • Any patient who cannot or will not provide informed consent for participation in the study
• • Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems