Stiffness and Low Dose Irradiation RCT (NCT07767097)
Treatment of Acquired Idiopathic Stiffness in Revision Total Knee Arthroplasty With Hinged Knee Prosthesis With or Without Low Dose Irradiation: A Multicentre Prospective Randomized Controlled Trial
🩺 Plain-English Summary (8th-Grade Level)
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 can join: Review the eligibility criteria below.
Location: University of Southern California — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
- Low-Dose External Beam Irradiation (RADIATION)
- Hinged Revision Total Knee Arthroplasty (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (4 Sites)
- University of Southern California — Los Angeles, California
- University of Utah — Salt Lake City, Utah
- Humber River Hospital — Toronto, Ontario
- Mount Sinai Hospital — Toronto, Ontario
📞 Contact the Study Coordinator
Phone: (416) 586-4800
Email: jesse.wolfstadt@sinaihealth.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Arthrofibrosis of Knee clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.