Hip replacement using Logica Mirror femoral stem
A Post-market Study Evaluating Clinical and Radiographic Early Outcomes of Hip Arthroplasty with Logica Mirror Stem.
Limacorporate S.p.a · NCT05003739
This study is testing how well the Logica Mirror femoral stem works and its safety for people who have had hip replacement surgery over three years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Limacorporate S.p.a (industry) |
| Locations | 1 site (Kyjov, CZ Republic) |
| Trial ID | NCT05003739 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the Logica Mirror femoral stem, a CE marked medical device used in hip arthroplasty. It aims to collect additional evidence on the outcomes of this implant by analyzing clinical scoring systems, radiographs, and adverse event records over a three-year period following surgery. The study will assess the short-term performance and safety of the Logica Mirror femoral stem in patients who have undergone hip replacement surgery.
Who should consider this trial
Good fit: Ideal candidates are patients who have undergone partial or total hip arthroplasty with the Logica Mirror femoral stem between January 2010 and December 2021.
Not a fit: Patients under 18 years old or those who are pregnant, nursing, or planning a pregnancy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of the Logica Mirror femoral stem for hip replacement patients.
How similar studies have performed: Other studies have shown success with similar approaches in evaluating the performance of hip implants, making this study a continuation of established research.
Eligibility criteria
Show full inclusion / exclusion criteria
All patients that underwent partial or total hip arthroplasty and implanted with LOGICA MIRROR femoral stem between Jan 2010 and Dec 2021 at Nemocnice Kyjov Hospital (CZ) in accordance with the indication for use of the product and site standard of practice. Additional Inclusion criteria: * Availability of patients' immediate post-operative radiograph (baseline) and of a number of follow-up x-rays that the Principal Investigator deems sufficient for an effective radiographic implant evaluation and stability assessment; * Patient is willing and able to complete additional follow-up evaluations if needed after signing ICF. Exclusion criteria * Age \< 18 years; * Female patients who are pregnant, nursing, or planning a pregnancy
Where this trial is running
Kyjov, CZ Republic
- Nemocnice Kyjov Hospital — Kyjov, CZ Republic, Czechia (RECRUITING)
Study contacts
- Study coordinator: Francesca Citossi
- Email: francesca.citossi@enovis.com
- Phone: +390432945357
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.
Conditions: Hip Replacement, Cemented femoral stem