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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Total arc of knee range of motion (ROM)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Low-Dose External Beam Irradiation (Radiation)
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.
干预措施: Hinged Revision Total Knee Arthroplasty (Procedure)
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.
干预措施: Hinged Revision Total Knee Arthroplasty (Procedure)
结局指标
主要结局
Total arc of knee range of motion (ROM)
时间窗: 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.
次要结局
- Reoperation Rate(2 weeks, 6 weeks, 3 months, 1 year)
- Oxford Knee Score (OKS)(Pre-op, 2 weeks, 6 weeks, 3 months, 1 year)
- EQ-5D-5L (health-related quality of life)(Pre-op, 2 weeks, 6 weeks, 3 months, 1 year)
- Visual Analogue Scale (VAS) - Pain(Pre-op, 2 weeks, 6 weeks, 3 months, 1 year)
- Patient Satisfaction (numeric rating)(6 weeks, 3 months, 1 year)
- Wound complications (requiring intervention)(2 weeks, 6 weeks, 3 months, 1 year)
- Infection rate(2 weeks, 6 weeks, 3 months, 1 year)
- Medical complications(2 weeks, 6 weeks, 3 months, 1 year)
研究者
Jesse Wolfstadt
Division Head of Orthopaedic Surgery
Mount Sinai Hospital, Canada