Stiffness and Low Dose Irradiation RCT

Conditions

• Arthrofibrosis of Knee

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Low-Dose External Beam Irradiation — RADIATION
  A single session of external beam irradiation (800 cGy) delivered to the operative knee on post-operative day 1 (or post-operative day 2 if medically necessary). At Mount Sinai Hospital and Humber River Hospital, LDI is delivered at Princess Margaret Cancer Centre. US sites coordinate through local radiation oncology departments.
• Hinged Revision Total Knee Arthroplasty — PROCEDURE
  Full component revision to a rotating hinge knee prosthesis, including synovectomy, posterior capsule debridement, and release of fibrosed collateral ligaments, performed by the treating orthopaedic surgeon at each participating site.

Study Details

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.

Key Dates

First listed

Aug 17, 2026

Start date

Apr 1, 2026

Status verified

Mar 2026

Primary completion

Dec 31, 2028

Completion

Jan 31, 2029

Study Design

Enrollment

36 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Hinged Revision TKA + Low-Dose Irradiation
  Patients undergo hinged revision total knee arthroplasty (TKA) with a rotating hinge prosthesis, followed by a single session of external beam low-dose irradiation (LDI) delivering 800 cGy to the operative knee on post-operative day 1 (or post-operative day 2 if medically necessary), coordinated with radiation oncology.
• Active Comparator: Hinged Revision TKA Alone
  Patients undergo hinged revision total knee arthroplasty (TKA) with a rotating hinge prosthesis and receive standard postoperative care without low-dose irradiation. All perioperative care, rehabilitation, and follow-up protocols are identical to the experimental arm.

Primary Outcome Measure

Total arc of knee range of motion (ROM) [ Time Frame: Baseline (pre-operative), intraoperative, 2 weeks, 6 weeks, 3 months, and1 year post-operatively. ]

Central Contacts

• Jesse Wolfstadt, MD, MSc
  416-586-4800
  [email protected]
• Ravianne Tuazon, BSc
  416-586-4800
  [email protected]

Locations (2)

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