New combo surgery aims to save knees from osteoarthritis

NCT ID NCT05840887

Disease control Sponsor: Istituto Ortopedico Rizzoli Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two knee surgeries for people with knee osteoarthritis, a meniscus problem, and a misaligned leg. Half the participants will get a standard realignment surgery, and the other half will get that plus a donor meniscus transplant. The goal is to see if the combined approach leads to better knee function and less pain over time.

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Study facts

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

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 52 people

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

Started

Aug 2023

Expected to finish

Jun 2026

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.

Ages

20 to 60 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. Male or female patients aged between 20 and 60 years; 2. Single-compartment tibiofemoral osteoarthritis (Kellgren-Lawrence grade ≤ 3); 3. Surgical indication of corrective osteotomy (axial deviation of lower extremities \> 5°); 4. Meniscal deficit of the compartment affected by the overload due to malalignment; 5. Ability and consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up (RX and MRI) 6. Signature of informed consent Exclusion Criteria: 1. Patients who are incapacitated or have neurological disorders that may invalidate the research protocol; 2. Diagnosis of neoplastic diseases; 3. Diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis or arthritis resulting from another inflammatory disease; human immunodeficiency virus (HIV) infection, viral hepatitis; chondrocalcinosis; 4. Patients with uncontrolled diabetes mellitus; 5. Patients with uncontrolled thyroid metabolic disorders; 6. Patients abusing alcoholic beverages, drugs or medications; 7. Body Mass Index \> 40; 8. Pregnancy or lactation status or intention to become pregnant during the period of study participation; 9. Patients undergoing knee surgery in the previous 12 months.

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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.

Malalignment, bone Osteoarthritis, knee

How to take part

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

The places running it

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

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

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A doctor treating you

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New combo surgery aims to save knees from osteoarthritis

What the study statuses mean