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Could a single radiation dose unlock stiff knees after revision surgery?

NCT ID NCT07767097

Disease control Sponsor: Mount Sinai Hospital, Canada 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This trial tests whether adding a single low-dose radiation session to revision knee replacement surgery helps people with persistent knee stiffness (arthrofibrosis) after an initial knee replacement. Participants receive either the standard hinged knee prosthesis surgery alone or the same surgery plus radiation to the knee the day after. The main goal is to compare knee range of motion one year later, with additional measures of pain, function, and complications.

What this could mean

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

Active substance
Low-dose external beam irradiation (a single session of radiation to the knee after surgery)
What this could lead to
If effective, adding low-dose radiation to revision knee surgery could reduce scar tissue, improve knee motion, and lower the need for repeat operations.
What could go wrong
This is a small, early-stage trial, and results may not apply to everyone. Radiation carries risks like wound healing problems or infection, and the benefit over surgery alone is unproven.

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

About 36 people

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

Started

Apr 2026

Expected to finish

Jan 2029

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

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: * Adults (≥18 years) undergoing revision TKA with a hinged prosthesis for AIS after primary TKA * Patient with a ROM arc \<70 degrees or flexion contracture of \>20 degrees without any identifiable cause for stiffness (e.g. component oversizing, malrotation, infection, or periprosthetic fracture). Exclusion Criteria: * Revision for causes other than AIS (e.g., component malposition, infection, periprosthetic fracture) * Prior ipsilateral knee infection * Revision to non-hinged prosthesis * Medical contraindications to surgery * Medical contraindications to irradiation * Currently pregnant or planning to become pregnant during the study period

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As listed by the trial registrant

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

Arthrofibrosis of knee

How to take part

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

  1. The places running it

    4 sites in 2 countries. 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

  • Humber River Hospital

    NOT_YET_RECRUITING

    Toronto, Ontario, M3M 0B2, Canada

  • Mount Sinai Hospital

    RECRUITING

    Toronto, Ontario, M5G 1X5, Canada

  • University of Southern California

    NOT_YET_RECRUITING

    Los Angeles, California, 90007, United States

  • University of Utah

    NOT_YET_RECRUITING

    Salt Lake City, Utah, 84112, United States