|
The Medacta International SMS Post-Marketing Surveillance Study
RECRUITINGSponsored by Medacta International SA
Actively Recruiting
SponsorMedacta International SA
Started2015-07
Est. completion2032-07
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT02748408
Summary
This is a Post-Marketing Surveillance of SMS femoral stem prosthesis.
Eligibility
Age: 18 Years – 75 YearsHealthy volunteers accepted
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
Conditions6
ArthritisArthrosisAvascular Necrosis of the Femoral HeadCongenital Hip DysplasiaRheumatoid PolyarthritisTraumatic Arthritis
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
Actively Recruiting
SponsorMedacta International SA
Started2015-07
Est. completion2032-07
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT02748408