Stiffness and Low Dose Irradiation RCT

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMount Sinai Hospital, Canada

About 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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

36 Participants
are divided into 2 treatment groups

Sponsors and collaborators