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Magnetic pulses may protect knees from osteoarthritis damage

NCT ID NCT06459817

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study tests whether a device called BB-02, which delivers pulsed electromagnetic fields, can slow cartilage damage in people with early knee osteoarthritis. Researchers will use MRI scans to measure changes in cartilage and track pain levels. The goal is to find a non-surgical way to delay knee replacement in younger, active patients.

What this could mean

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

Active substance
pulsed electromagnetic field therapy (BB-02 device)
What this could lead to
If effective, this non-invasive therapy could help delay knee replacement surgery in younger patients by preserving cartilage and reducing pain.
What could go wrong
This is a small, early-stage study (30 people) without a control group, so results may not prove effectiveness. The therapy may not slow cartilage loss or relieve symptoms for everyone.

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.

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

30 people

The number who actually took part.

Started

Jul 2024

Finished

May 2026

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 55 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: * Both sexes aged between 20 and 55 years. * Body Mass Index, BMI \< 35. * Subjects with Kellgren-Lawrence grade 2 osteoarthritis. * Subjects with baseline Visual Analog Scale (VAS) score ≥ 2. * Mechanical alignment between 175° and 185°. * Absence of acute ligamentous or meniscal pathology. Exclusion Criteria: * Patients with systemic inflammatory or neoplastic diseases * Smokers * Individuals with hypertension or diabetes * Knee arthroscopy within the 12 months prior to enrollment * Subjects diagnosed with inflammatory arthritis (rheumatoid arthritis, gout, joint infections, Lyme disease, lupus, etc.) * Subjects diagnosed with secondary arthritis (acromegaly, Charcot arthropathy, hemochromatosis, Wilson's disease, ochronosis, anterior cruciate ligament injuries) * Patients undergoing analgesic therapy with opioids, systemic corticosteroids, or intra-articular corticosteroids during study participation * Patients undergoing intra-articular injections of hyaluronic acid during the study participation * Patients unable to provide informed consent * Pregnant and breastfeeding women * Women in menopause

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Istituto Ortopedico Rizzoli

    Bologna, 40136, Italy

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