Low-Dose Irradiation for Knee Arthrofibrosis
(LDI TKR RCT Trial)
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?
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
Exclusion Criteria
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
Patients undergo hinged revision total knee arthroplasty (TKA) with a rotating hinge prosthesis, followed by a single session of external beam low-dose irradiation (LDI) delivering 800 cGy to the operative knee on post-operative day 1 (or post-operative day 2 if medically necessary), coordinated with radiation oncology.
Patients undergo hinged revision total knee arthroplasty (TKA) with a rotating hinge prosthesis and receive standard postoperative care without low-dose irradiation. All perioperative care, rehabilitation, and follow-up protocols are identical to the experimental arm.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mount Sinai Hospital, Canada
Lead Sponsor
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