NCT07815080 Femoral Component TKA: Extramedullary vs Conventional Intramedullary Guide
| NCT ID | NCT07815080 |
| Status | Recruiting |
| Phase | — |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio |
| Condition | Total Knee Replacement |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-10-15 |
| Primary Completion | 2027-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2025-10-15 with a primary completion date of 2027-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study wants to evaluate the performance of this EM guide in comparison to a traditional IM guide. 75 patients will be included in the extramedullary group (to be compared with a corresponding previous group of 75 patients treated with intramedullary guide).
Eligibility Criteria
Inclusion Criteria: * Male or female ≥ 18 years old * Indication to primary TKA, for any diagnosis operated with EM or IM guides * Signature of the informed consent (only for prospective cohort) * Been operated upon between January 2021 and September 2025 (only for retrospective cohort) Exclusion Criteria: * Revision surgery of knee arthroplasty * Patients with malignant diseases (at the time of surgery) * Patients with proven or suspect infections (at the time of surgery) * Pregnancy end/or lactating (auto declaration) * Patient with known allergy to the specific metallic components of the prosthesis (at the time of surgery)
Contact & Investigator
Corrado Sosio
PRINCIPAL INVESTIGATOR
Ospedale Galeazzi S.p.A.
Frequently Asked Questions
Who can join the NCT07815080 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Total Knee Replacement. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07815080 currently recruiting?
Yes, NCT07815080 is actively recruiting participants. Contact the research team at sara.zacchetti@grupposandonato.it for enrollment information.
Where is the NCT07815080 trial being conducted?
This trial is being conducted at Milan, Italy, Milan, Italy, Torino, Italy.
Who is sponsoring the NCT07815080 clinical trial?
NCT07815080 is sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. The principal investigator is Corrado Sosio at Ospedale Galeazzi S.p.A.. The trial plans to enroll 150 participants.