NCT Number: NCT07767097
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Humber River Hospital, Toronto, Ontario, Canada
Acquired idiopathic stiffness (AIS), or arthrofibrosis, is a rare but potentially devastating complication after total knee arthroplasty (TKA), occurring in approximately 1-6% of cases. It is characterized by pathological fibroblast and myofibroblast proliferation leading to excessive scar tissue deposition within and around the knee joint, resulting in restricted range of motion (ROM), pain, and functional impairment.
When conservative management (physiotherapy, manipulation under anesthesia) fails, operative intervention is required. Full component revision to a hinged prosthesis - which permits complete synovectomy, posterior capsule release, and debridement of fibrosed collateral ligaments - has demonstrated superior ROM outcomes compared to partial revision strategies.
Perioperative low-dose irradiation (LDI) has an established role in the prophylaxis of heterotopic ossification following total hip arthroplasty and is used as adjunctive therapy for keloid prevention. Mechanistically, LDI at 700-800 cGy inhibits myofibroblast proliferation and modulates fibrotic signaling pathways, addressing the underlying pathophysiology of arthrofibrosis. A retrospective review of 60 patients undergoing hinged revision TKA with LDI demonstrated a median ROM improvement of 60°, with acceptable complication rates.
Despite this evidence, no prospective randomized controlled trial has compared hinged revision TKA with and without LDI.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline (pre-operative), intraoperative, 2 weeks, 6 weeks, 3 months, and1 year post-operatively.
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: Pre-op, 2 weeks, 6 weeks, 3 months, 1 year
Time frame: Pre-op, 2 weeks, 6 weeks, 3 months, 1 year
Time frame: Pre-op, 2 weeks, 6 weeks, 3 months, 1 year
Time frame: 6 weeks, 3 months, 1 year
Time frame: 2 weeks, 6 weeks, 3 months, 1 year
Time frame: 2 weeks, 6 weeks, 3 months, 1 year
Time frame: 2 weeks, 6 weeks, 3 months, 1 year
Time frame: 2 weeks, 6 weeks, 3 months, 1 year
Contact information is provided by the study sponsor or research team.
Jesse Wolfstadt, MD, MSc
CONTACT
416-586-4800 ext. 8457
Ravianne Tuazon, BSc
CONTACT
416-586-4800 ext. 4759
Mount Sinai Hospital, Canada
Other
Treatment of Acquired Idiopathic Stiffness in Revision Total Knee Arthroplasty With Hinged Knee Prosthesis With or Without Low Dose Irradiation: A Multicentre Prospective Randomized Controlled Trial
Acronym: LDI TKR RCT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04998656
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Aurora, Colorado, United States
View Trial Details