Recruiting

Revision TKA with LDI

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT07767097

Conditions

Arthrofibrosis of Knee

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Low-Dose External Beam Irradiation

Hinged Revision Total Knee Arthroplasty

Study Details

Brief summary:

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.

Conditions

Arthrofibrosis of Knee

Study ID

NCT07767097

Start date

Apr 1, 2026

Status verified date

Mar, 2026

Completion date

Jan 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Low-Dose External Beam Irradiation

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

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.

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 and Locations

Central contacts

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Principal Investigator:

Jesse Wolfstadt, MD

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Aug 17, 2026

Last verified

Mar, 2026

Keywords

  • arthrofibrosis
  • stiffness
  • revision knee
  • low dose irradiation
  • hinged knee prosthesis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2026-08-17.