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Can a knee realignment surgery delay joint replacement?

NCT ID NCT06462625

Disease control Sponsor: Istituto Ortopedico Rizzoli 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 150 people with knee osteoarthritis and leg misalignment who had a knee osteotomy—a surgery that realigns the bones to take pressure off the damaged part of the knee. Researchers want to see how well the knee works years later and whether this surgery can help patients avoid or delay getting a knee replacement. Participants are between 18 and 70 years old and may also have other procedures like meniscus repair or ligament reconstruction.

What this could mean

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

Active substance
knee osteotomy (surgical realignment of the knee bone)
What this could lead to
If successful, this could show that knee osteotomy is a reliable way to manage osteoarthritis and postpone the need for knee replacement surgery.
What could go wrong
This is an observational study, not a controlled trial, so results may not prove cause and effect. Long-term success depends on many factors, and some patients may still need joint replacement later.

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

Jan 2023

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

Based on the number of patients treated at Rizzoli with this type of surgical intervention and considering a 25% dropout rate, it is estimated that 150 patients with a follow-up period of 2 to 20 years can be included in the study. It is noteworthy that previous studies with similar aims have a patient sample similar to that proposed by the current study.

Ages

18 to 70 years

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: 1. Patients undergoing corrective knee osteotomy and any associated procedures such as meniscal repair/resection/replacement, ligament reconstruction, chondral treatment, or regenerative infiltrative treatment; 2. Patients aged between 18 and 70 years at the time of surgical intervention; 3. Patients with isolated compartmental osteoarthritis; 4. Patients with a varus or valgus knee alignment defect of at least 3° compared to mechanical neutrality. Exclusion Criteria: 1. Patients with advanced multicompartimental osteoarthritis; 2. Patients who are no longer reachable; 3. Women of childbearing age who cannot exclude pregnancy; 4. Patients unable to give informed consent or patients unwilling to sign the informed consent form.

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Conditions

The condition(s) this trial relates to.

Bone Malalignment osteoarthritis, knee

As listed by the trial registrant

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

Knee osteoarthritis Malalignment, bone

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 Istituto Ortopedico Rizzoli

    RECRUITING

    Bologna, 40136, Italy

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