Adverse Reactions to Metal Debris, Infection of Total Hip Joint Prosthesis, Mechanical Loosening of Prosthetic Joint
Conditions
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.
Interventions
DIAGNOSTIC_TEST68Ga-citrate and 18F-FDG PET/CT imaging
Single-day study of the two PET tracers
Sponsors
Turku University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Intervention model description
Intra-individual comparison of two diagnostic PET imaging tracers
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exclusion of the presence of periprosthetic joint infection in ARMD patients | 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 |
Countries
Finland
Outcome results
None listed