Prospective Intra-individual Comparison of 18F-FDG and 68Ga-citrate PET/CT in Symptomatic Total Hip Arthroplasty Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Exclusion of the presence of periprosthetic joint infection in ARMD patients
研究概览
简要总结
Total hip replacement is the well-established surgical method for treatment of hip osteoarthritis and related diseases. The outcome of the procedure is commonly satisfactory and most patients will not need any revision surgery. However, the procedure has its complications, including (1) periprosthetic infection, (2) mechanical loosening caused by wear particles and (3) adverse reaction caused by metal ions released from metal-on-metal bearing surfaces. The unsolved clinical problem is related to the differential diagnosis of these conditions. The purpose of this prospective clinical study is to compare the efficacy of two techniques of PET/CT imaging in the differential diagnosis of these complications. Positron Emission Tomography (PET)/Computed Tomography (CT) imaging, performed during a single day, will include the head-to-head comparison of 18F-Fluoro-D-Glucose (18F-FDG) PET/CT and 68Gallium-citrate (68Ga-citrate) PET/CT imaging.
详细描述
(68Ga) gallium citrate is a novel PET tracer aimed for detection of skeletal infections. It has not been previously applied to diagnose periprosthetic joint infections in arthroplasty patients. This exploratory prospective study, representing the first of its kind, examines the use of 68Ga-citrate as a diagnostic tool of periprosthetic infections aside with 18F-FDG tracer as the standard reference.
The first study group (n=10) will include total hip replacement patients without infection. The recruited patients should suffer from pain and/or functional impairment due to adverse reaction to metal debris (ARMD) caused by metal-on-metal bearings. The diagnosis of ARMD should be based on metal artifact reduction sequence magnetic resonance imaging (MARS-MRI). The patients will undergo the same-day comparison of the two PET/CT tracers.
The second study group (n=10) will include total hip replacement patients with bacteriologically confirmed periprosthetic joint infection. The third group (n=10) will include patients with aseptic loosening of total hip prosthesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- •Adult patients with uncemented total hip replacement
- •American Society of Anesthesiology score I-III
- •Group 1: local symptoms and MRI findings of the operated hip fulfilling the criteria of ARMD due to metal-on-metal bearings of the hip prosthesis, infection ruled out
- •Group 2: bacteriologically verified periprosthetic infection of the hip prosthesis
- •Group 3: local symptoms and radiographic findings of the hip prosthesis fulfilling the criteria of aseptic mechanical implant loosening, infection ruled out
排除标准
- •any related condition of the index hip which requires immediate surgical intervention, such as a septic infection or a periprosthetic fracture
- •any systemic disorder or condition (ASA IV) which makes the patient an unlikely candidate for revision surgery of the affected hip implant
研究组 & 干预措施
Periprosthetic joint infection
68Ga-citrate and 19F-FDG PET/CT imaging of hip replacement patients with periprosthetic joint infection
干预措施: 68Ga-citrate and 18F-FDG PET/CT imaging (Diagnostic Test)
Adverse reaction to metal debris
68Ga-citrate and 19F-FDG PET/CT imaging of hip replacement patients with adverse tissue reactions to metal debris
干预措施: 68Ga-citrate and 18F-FDG PET/CT imaging (Diagnostic Test)
Aseptic mechanical implant loosening
68Ga-citrate and 19F-FDG PET/CT imaging of patients with aseptic mechanical loosening of hip prosthesis
干预措施: 68Ga-citrate and 18F-FDG PET/CT imaging (Diagnostic Test)
结局指标
主要结局
Exclusion of the presence of periprosthetic joint infection in ARMD patients
时间窗: Clinical follow-up of 3 years or more after PET/CT imaging
The two PET imaging techniques are expected to rule out infection in patients with ARMD due to metal-on-metal bearings
次要结局
未报告次要终点