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Recruiting
NCT07815080
Femoral Component TKA: Extramedullary vs Conventional Intramedullary Guide
Conditions: Total Knee Replacement
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 150
Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Location: Istituto Clinico San Siro Milan
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)
Source: ClinicalTrials.gov (NCT07815080). StuddyBuddy aggregates publicly available trial information.