Femoral Component Alignment in Total Knee Replacement: Extramedullary vs Intramedullary Guidance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study compares two methods for guiding the femoral cut during total knee replacement: an extramedullary guide and the conventional intramedullary guide. It includes 75 patients treated with the extramedullary approach and compares them to a previous group of 75 patients who received the intramedullary guide, aiming to assess alignment outcomes and potential surgical risks. The investigation considers the influence of alignment technique within a kinetic alignment framework to mimic natural knee biomechanics. Outcomes of interest likely include implant positioning accuracy, postoperative knee function, and complication rates related to canal reaming and fat embolism. The study leverages both prospective and retrospective data across multiple Milan-area centers to evaluate real-world performance of the Anterior Cortex Stylus EM guide.

Why it matters

Who can join: the full rules

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)

Where it's running

• IRCCS Ospedale Galeazzi-Sant'Ambrogio [coordinator]
  Milan, Italy Recruiting
• Istituto Clinico San Siro
  Milan, Italy Completed
• Ospedale Cottolengo
  Torino, Italy Completed

Study contacts

• Principal investigator: Corrado Sosio — Ospedale Galeazzi S.p.A.
• Study coordinator: Sara Zacchetti
• Email: sara.zacchetti@grupposandonato.it
• Phone: 0283502227

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.