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Stiffness and Low Dose Irradiation RCT

Recruiting

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria

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

About the study

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.

What is being tested

Low-Dose External Beam Irradiation (radiation)
Hinged Revision Total Knee Arthroplasty (procedure)

Sponsor: Mount Sinai Hospital, Canada · Participants: 36 · Started: Apr 1, 2026

Contact the study team

Jesse Wolfstadt, MD, MSc · Phone: 416-586-4800
Ravianne Tuazon, BSc · Phone: 416-586-4800

Official record on ClinicalTrials.gov — NCT07767097

Locations in the U.S.

California	University of Southern California, Los Angeles (Not yet recruiting)
Utah	University of Utah, Salt Lake City (Not yet recruiting)

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.