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Knee injection during surgery may ease arthritis pain

NCT ID NCT04641351

Symptom relief Sponsor: The Cleveland Clinic Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 01, 2026 · Updated 3 times

Summary

This study tests whether an extended-release steroid injection (Zilretta) given during knee meniscus surgery can reduce pain and inflammation in people with osteoarthritis. 150 adults aged 40 and older are enrolled. Researchers will measure knee pain scores and inflammatory markers over 12 months to see if the injection improves outcomes.

What this could mean

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

Active substance
triamcinolone acetonide (extended-release steroid injection)
What this could lead to
If it works, this could provide a way to reduce knee pain and inflammation after meniscus surgery, potentially slowing osteoarthritis progression.
What could go wrong
This is a Phase 4 trial with 150 participants, so results may not apply to everyone. Steroid injections carry risks like infection or joint damage, and the benefit may be small or temporary.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 150 people

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

Started

May 2021

Expected to finish

Aug 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.

Ages

40 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: 1. Male or female age 40 and older 2. Scheduled for APM with enrolling surgeon 3. Arthroscopic evidence of structural OA including at least one surface with grade 2 chondral change 4. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study. Exclusion Criteria: 1. Females who are pregnant or nursing or plan to become pregnant during the study; men who plan to inseminate a partner or donate sperm 2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. 3. Known or suspected hypersensitivity to Zilretta (or component of Zilretta) or triamcinolone acetonide 4. Kellgren and Lawrence Grade IV (severe OA; arthroplasty is typically preferred over APM in this setting) 5. Injection with corticosteroid into affected knee in past 12 weeks 6. Injection with platelet rich plasma into affected knee in past 12 weeks 7. Injection with hyaluronic acid into affected knee in past 24 weeks 8. Plan for cartilage resurfacing procedure (microfracture, autologous chondrocyte implantation, osteochondral autograft or allograft), ligament reconstruction or other open procedure 9. Bilateral surgery 10. Unable to undergo MRI due to implanted medical device, aneurysm clamp, metal fragments in eye, etc. 11. Absence of at least one area of grade 2 chondral change on diagnostic arthroscopy (patients without structural OA are excluded)

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Conditions

The condition(s) this trial relates to.

osteoarthritis, knee synovitis

As listed by the trial registrant

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

Meniscus tear Meniscus; degeneration Osteoarthritis, knee Synovitis

Contacts and locations

Locations

  • Bringham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

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