Femoral Component TKA: Extramedullary vs Conventional Intramedullary Guide

NCT07815080 | Recruiting

• 1 other identifier: EMAX (L2055)
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

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).

Conditions

Total Knee Replacement

Keywords

Total Knee Replacement; Extramidollary Guide; Intramedullary Guide

Outcome Measures

Primary Outcomes (1)

• Anterior Cortex Stylus

  Radiographic angle at 3 moth post-op of the femoral component in TKA in an Anterior Cortex Stylus (retro-prospective collected series) compared to intramedullary guide (previous group of patients)

  Radiographic angle at 3 moth post-op in the sagittal plane, between the anterior cortex of the distal femur and the femoral component and compare it in the group operated with Anterior Cortex Stylus versus the group operated with IM guide.

Secondary Outcomes (2)

• Results across study centres

  Compare the results in terms of radiographic sagittal angle between study centres at pre-op, surgery and 3 month post-op.

• Adverse Events to determinate Instrument safety

  During surgery

Study Arms (2)

Extramedullary (EM) guides: Retroprospective + Prospective cohort

patients trated with extramedullary (EM) guides. This cohort can be both Retroprospective and Prospective

intramedullary (IM) guides: Retrospective cohort

patients trated with intramedullary (IM) guides. This cohort will be only Retrospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study shall include a total of 150 patients: 75 will be included in the extramedullary group, to be compared with a corresponding previous group of 75 patients treated with intramedullary guide. Patients meeting the inclusion criteria (mentioned below) will be recruited separately by each participating institution. Patient enrolled in the retrospective analysis have been operated upon between January 2021 and September 2025.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (3)

Istituto Clinico San Siro

Milan, 20148, Italy

COMPLETED

IRCCS Ospedale Galeazzi-Sant'Ambrogio [coordinator]

Milan, 20157, Italy

RECRUITING

Ospedale Cottolengo

Torino, 10152, Italy

COMPLETED

Study Officials

• Corrado Sosio

  Ospedale Galeazzi S.p.A.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Zacchetti

CONTACT

0283502227; sara.zacchetti@grupposandonato.it

Laura Mangiavini

CONTACT

0283502227

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 11, 2026
• Study Start: October 15, 2025
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: September 11, 2026

Record last verified: 2026-09

Locations

IT (3)