Stiffness and Low Dose Irradiation RCT
Eligible age
18+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
See if you qualify for this study
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About this 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.
Sponsor: Mount Sinai Hospital, Canada
You may qualify if…
- ✓ 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).
You may not qualify if…
- ✕ 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
Where it's recruiting
Los Angeles
Salt Lake City
Source: ClinicalTrials.gov · NCT07767097 · last updated 2026-08-17