36 Participants NeededMy employer runs this trial

Low-Dose Irradiation for Knee Arthrofibrosis

(LDI TKR RCT Trial)

Recruiting at 3 trial locations
JW
RT
Overseen ByRavianne Tuazon, BSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mount Sinai Hospital, Canada
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Acquired idiopathic stiffness (AIS) is a common complication following total knee arthroplasty (TKA). It is caused by excessive scar formation, which leads to pain, loss of motion, and functional impairment. When early noninvasive treatments fail, some patients require more surgery. In these cases, surgeons often use a special type of replacement called a hinged prosthesis, which allows more thorough removal of scar tissue and stiffened ligaments. Unfortunately, even after more surgery, many patients continue to struggle with stiffness, pain, and impaired function. Low-dose irradiation (LDI) is a safe, established therapy for conditions with abnormal scar formation. Its role in the setting of AIS has not been defined. The goal of this study is to compare outcomes of revision TKA with or without the addition of LDI. The primary outcome is range of motion at one year following surgery. Secondary outcomes include patient-reported functional scores, repeat surgeries, and complications like wound breakdown or infection. This project has the potential to address a common, debilitating complication after TKA, improve outcomes, reduce repeat interventions and healthcare costs, and broader implementation and standardization of care.

Who Is on the Research Team?

JW

Jesse Wolfstadt, MD, MSc

Principal Investigator

MOUNT SINAI HOSPITAL

Are You a Good Fit for This Trial?

This trial is for people who have developed significant knee stiffness (arthrofibrosis) after a total knee replacement and need another surgery with a hinged knee implant. Participants should not have other conditions that would prevent them from safely joining the study.

Inclusion Criteria

My joint is stiff with limited movement and no clear cause for the stiffness.
I am 18 or older and having a hinged knee replacement revision for AIS after my first knee surgery.

Exclusion Criteria

I have had an infection in my knee on this side before.
Currently pregnant or planning to become pregnant during the study period
My surgery revision was not due to implant loosening.
See 3 more

What Are the Treatments Tested in This Trial?

Interventions

  • Hinged Revision Total Knee Arthroplasty
  • Low-Dose External Beam Irradiation

Trial Overview

The study compares two treatments for stiff knees after knee replacement: one group gets revision surgery with a hinged prosthesis plus low-dose radiation, while the other group gets only the revision surgery. Patients are randomly assigned to each group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Hinged Revision TKA + Low-Dose IrradiationExperimental Treatment2 Interventions
Group II: Hinged Revision TKA AloneActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mount Sinai Hospital, Canada

Lead Sponsor

Trials
210
Recruited
70,700+