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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

    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.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Hinged Revision TKA + Low-Dose IrradiationExperimental treatment 2 interventions
Group B: Hinged Revision TKA AloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total arc of knee range of motion (ROM)

Goniometric measurement of total arc of motion (flexion minus extension deficit) performed by treating surgeon at each follow-up visit, per standard clinical protocol.

Time frame
Baseline (pre-operative), intraoperative, 2 weeks, 6 weeks, 3 months, and1 year post-operatively.

Secondary outcomes

1

Oxford Knee Score (OKS)

Time frame
Pre-op, 2 weeks, 6 weeks, 3 months, 1 year
2

EQ-5D-5L (health-related quality of life)

Time frame
Pre-op, 2 weeks, 6 weeks, 3 months, 1 year
3

Visual Analogue Scale (VAS) - Pain

Time frame
Pre-op, 2 weeks, 6 weeks, 3 months, 1 year
4

Patient Satisfaction (numeric rating)

Time frame
6 weeks, 3 months, 1 year

Other outcomes

Sponsors and contacts

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