Clinical trial NCT01970228: Imaging of Joint Replacement Complications by PET/CT
Official title: Prospective Intra-individual Comparison of 18F-FDG and 68Ga-citrate PET/CT in Symptomatic Total Hip Arthroplasty Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Reactions to Metal Debris
Infection of Total Hip Joint Prosthesis
Mechanical Loosening of Prosthetic Joint
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2013-10-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intra-individual comparison of two diagnostic PET imaging tracers
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: (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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Exclusion of the presence of periprosthetic joint infection in ARMD patients
timeFrame: Clinical follow-up of 3 years or more after PET/CT imaging
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital
name: Hannu T Aro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.