Cure My Disease

Don't miss your cure!

 Log in / Sign up

Knee replacement: can a different guide improve implant alignment?

NCT ID NCT07815080

Symptom relief Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers compare two tools for positioning the femoral component during total knee replacement: an extramedullary guide and the standard intramedullary guide. The study includes 75 patients treated with the extramedullary guide and compares them with 75 earlier patients treated with the intramedullary guide. The main measure is the angle of the implant on X-rays taken three months after surgery. The study also tracks adverse events to check the safety of the extramedullary guide.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
extramedullary alignment guide for total knee replacement
What this could lead to
If the extramedullary guide works as well as the standard guide, surgeons could have an alternative way to position the knee implant that avoids drilling into the thigh bone's canal.
What could go wrong
This is a comparison study, not a test of a new drug, and it may show no meaningful difference between the two guides. The retrospective part uses past patient records, which can introduce bias, and the results may not apply to all knee replacement patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Total knee replacement are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Total knee replacement

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IRCCS Ospedale Galeazzi-Sant'Ambrogio [coordinator]

    RECRUITING

    Milan, 20157, Italy

  • Istituto Clinico San Siro

    COMPLETED

    Milan, 20148, Italy

  • Ospedale Cottolengo

    COMPLETED

    Torino, 10152, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.