Adverse Reactions to Metal DebrisPropeliNCT01970228
Imaging of Joint Replacement Complications by PET/CT
A study testing 68Ga-citrate and 18F-FDG PET/CT imaging in people with Adverse Reactions to Metal Debris and Infection of Total Hip Joint Prosthesis, run by Turku University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adverse Reactions to Metal Debris, Infection of Total Hip Joint Prosthesis, Mechanical Loosening of Prosthetic Joint
- What is being tested?
- 68Ga-citrate and 18F-FDG PET/CT imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2012to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Intra-individual Comparison of 18F-FDG and 68Ga-citrate PET/CT in Symptomatic Total Hip Arthroplasty Patients
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.
Read the 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.
- Conditions
- Adverse Reactions to Metal Debris, Infection of Total Hip Joint Prosthesis, Mechanical Loosening of Prosthetic Joint
- Being tested
- 68Ga-citrate and 18F-FDG PET/CT imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-citrate and 18F-FDG PET/CT imagingDiagnostic test
Single-day study of the two PET tracers
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: 68Ga-citrate and 18F-FDG PET/CT imaging |
| Periprosthetic joint infection | Active comparator | 68Ga-citrate and 19F-FDG PET/CT imaging of hip replacement patients with periprosthetic joint infection Receives: Diagnostic Test: 68Ga-citrate and 18F-FDG PET/CT imaging |
| Aseptic mechanical implant loosening | Active comparator | 68Ga-citrate and 19F-FDG PET/CT imaging of patients with aseptic mechanical loosening of hip prosthesis Receives: Diagnostic Test: 68Ga-citrate and 18F-FDG PET/CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Clinical follow-up of 3 years or more after PET/CT imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study startOct 2012
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Adverse Reactions to Metal DebrisStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intra-individual comparison of two diagnostic PET imaging tracers
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hannu T Aro, MD, PhD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970228
- Sponsor's protocol ID
- T125/2012
- Other IDs
- EVO13086
- Acronym
- Propeli
- Status last verified
- Aug 2017
- First submitted
- 19 Sep 2013
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22824200Lankinen 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.
PubMed 18038133Makinen 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.
PubMed 16007423Koort 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.
PubMed 15299068Ahtinen 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.
PubMed 25520903
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Intra-individual Comparison of 18F-FDG and 68Ga-citrate PET/CT in Symptomatic Total Hip Arthroplasty Patients
- ClinicalTrials.gov ID
- NCT01970228
- Acronym / sponsor ID
- Propeli / T125/2012
- Conditions
- Adverse Reactions to Metal Debris, Infection of Total Hip Joint Prosthesis, Mechanical Loosening of Prosthetic Joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Oct 2012 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 28 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Intra-individual comparison of two diagnostic PET imaging tracers
| Arm | Type | Receives |
|---|---|---|
| Adverse reaction to metal debris | Active comparator | Diagnostic Test: 68Ga-citrate and 18F-FDG PET/CT imaging68Ga-citrate and 19F-FDG PET/CT imaging of hip replacement patients with adverse tissue reactions to metal debris |
| Periprosthetic joint infection | Active comparator | Diagnostic Test: 68Ga-citrate and 18F-FDG PET/CT imaging68Ga-citrate and 19F-FDG PET/CT imaging of hip replacement patients with periprosthetic joint infection |
| Aseptic mechanical implant loosening | Active comparator | Diagnostic Test: 68Ga-citrate and 18F-FDG PET/CT imaging68Ga-citrate and 19F-FDG PET/CT imaging of patients with aseptic mechanical loosening of hip prosthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-citrate and 18F-FDG PET/CT imagingSingle-day study of the two PET tracers | Diagnostic test | Adverse reaction to metal debris, Aseptic mechanical implant loosening, Periprosthetic joint infection |
Primary outcome
Exclusion of the presence of periprosthetic joint infection in ARMD patients
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
- Background: PubMed 22824200Lankinen 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.
- Background: PubMed 18038133Lankinen 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.
- Background: PubMed 16007423Makinen 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.
- Background: PubMed 15299068Koort 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.
- Background: PubMed 25520903Ahtinen 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannu T Aro, MD, PhD principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-citrate and 18F-FDG PET/CT imaging in people with Adverse Reactions to Metal Debris and Infection of Total Hip Joint Prosthesis, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exclusion of the presence of periprosthetic joint infection in ARMD patients (time frame: Clinical follow-up of 3 years or more after PET/CT imaging). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01970228, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2017.