Post-marketing surveillance of a femoral stem prosthesis for hip replacement
The Medacta SMS Femoral Stem Component. A Multi-National, Multi-Centre, Clinical Surveillance Study
This study is tracking how well a specific hip replacement device works and its safety in people aged 18 to 75 who are having hip surgery for different joint problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 550 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Medacta International SA Industry-sponsored |
| Locations | 4 sites (Vienna and 3 other locations) |
| Trial ID | NCT02748408 on ClinicalTrials.gov |
What this trial studies
This observational study monitors the performance and outcomes of the SMS femoral stem prosthesis in patients undergoing total hip replacement. It aims to gather data on the effectiveness and safety of the prosthesis in individuals suffering from various hip joint conditions, including arthrosis and avascular necrosis. Participants will be followed for a period of 10 years to assess their progress and any potential complications associated with the implant. The study includes patients aged 18 to 75 who are scheduled for primary hip replacement surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18 to 75 with severely painful hip joint conditions who are scheduled for a primary total hip replacement.
Not a fit: Patients with active infections, pregnancy, or certain medical conditions that may compromise their ability to participate or benefit from the study will not receive benefit.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of the SMS femoral stem prosthesis, potentially improving patient outcomes in hip replacement surgeries.
How similar studies have performed: Other studies on post-marketing surveillance of orthopedic implants have shown success in monitoring long-term outcomes, suggesting this approach is validated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vienna and 3 other locations
- Herz-Jesu Krankenhaus — Vienna, Austria (Recruiting)
- Istituto Ortopedico Galezzi — Milan, Milan, Italy (Recruiting)
- Bürgerspital Solothurn — Solothurn, Switzerland (Recruiting)
- The Elective Orthopaedic Centre (EOC) — Epsom, Surrey, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Mara Colombo, Eng
- Email: colombo@medacta.ch
- Phone: 0041 91 6966060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.