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Stiffness and Low Dose Irradiation RCT

RecruitingNAAges 18 Years - anyAllMount Sinai Hospital, Canada
NCT07767097 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Sec

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📋 Eligibility rules (as published)
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
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What it tests

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

4 sites
University of Southern California
Los Angeles, United States
University of Utah
Salt Lake City, United States
Humber River Hospital
Toronto, Canada
Mount Sinai Hospital
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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