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| ID | Type | Description | Link |
|---|---|---|---|
| EVO13086 | Other Identifier | Turku University Hospital |
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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.
(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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adverse reaction to metal debris | Active Comparator | 68Ga-citrate and 19F-FDG PET/CT imaging of hip replacement patients with adverse tissue reactions to metal debris |
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| Periprosthetic joint infection | Active Comparator | 68Ga-citrate and 19F-FDG PET/CT imaging of hip replacement patients with periprosthetic joint infection |
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| Aseptic mechanical implant loosening | Active Comparator | 68Ga-citrate and 19F-FDG PET/CT imaging of patients with aseptic mechanical loosening of hip prosthesis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-citrate and 18F-FDG PET/CT imaging | Diagnostic Test | Single-day study of the two PET tracers |
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| Measure | Description | Time Frame |
|---|---|---|
| Exclusion of the presence of periprosthetic joint infection in ARMD patients | The two PET imaging techniques are expected to rule out infection in patients with ARMD due to metal-on-metal bearings | Clinical follow-up of 3 years or more after PET/CT imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hannu T Aro, MD, PhD | Turku University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turku University Hospital | Turku | 20521 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22824200 | Background | Lankinen P, Lehtimaki K, Hakanen AJ, Roivainen A, Aro HT. A comparative 18F-FDG PET/CT imaging of experimental Staphylococcus aureus osteomyelitis and Staphylococcus epidermidis foreign-body-associated infection in the rabbit tibia. EJNMMI Res. 2012 Jul 23;2(1):41. doi: 10.1186/2191-219X-2-41. | |
| 18038133 | Background |
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Intra-individual comparison of two diagnostic PET imaging tracers
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| Lankinen P, Makinen TJ, Poyhonen TA, Virsu P, Salomaki S, Hakanen AJ, Jalkanen S, Aro HT, Roivainen A. (68)Ga-DOTAVAP-P1 PET imaging capable of demonstrating the phase of inflammation in healing bones and the progress of infection in osteomyelitic bones. Eur J Nucl Med Mol Imaging. 2008 Feb;35(2):352-64. doi: 10.1007/s00259-007-0637-5. Epub 2007 Nov 24. |
| 16007423 | Background | Makinen TJ, Lankinen P, Poyhonen T, Jalava J, Aro HT, Roivainen A. Comparison of 18F-FDG and 68Ga PET imaging in the assessment of experimental osteomyelitis due to Staphylococcus aureus. Eur J Nucl Med Mol Imaging. 2005 Nov;32(11):1259-68. doi: 10.1007/s00259-005-1841-9. Epub 2005 Jul 9. |
| 15299068 | Background | Koort JK, Makinen TJ, Knuuti J, Jalava J, Aro HT. Comparative 18F-FDG PET of experimental Staphylococcus aureus osteomyelitis and normal bone healing. J Nucl Med. 2004 Aug;45(8):1406-11. |
| 25520903 | Background | Ahtinen H, Kulkova J, Lindholm L, Eerola E, Hakanen AJ, Moritz N, Soderstrom M, Saanijoki T, Jalkanen S, Roivainen A, Aro HT. (68)Ga-DOTA-Siglec-9 PET/CT imaging of peri-implant tissue responses and staphylococcal infections. EJNMMI Res. 2014 Aug 8;4:45. doi: 10.1186/s13550-014-0045-3. eCollection 2014. |