Imaging of Joint Replacement Complications by PET/CT

NCT01970228 | Completed

• 2 other identifiers: T125/2012EVO13086
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Adverse Reactions to Metal Debris; Infection of Total Hip Joint Prosthesis; Mechanical Loosening of Prosthetic Joint

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

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

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

Diagnostic Test: 68Ga-citrate and 18F-FDG PET/CT imaging

Interventions

68Ga-citrate and 18F-FDG PET/CT imaging DIAGNOSTIC_TEST

Single-day study of the two PET tracers

Adverse reaction to metal debris; Aseptic mechanical implant loosening; Periprosthetic joint infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku University Hospital

Turku, 20521, Finland

Location

Related Publications (5)

• 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.

  PMID: 22824200 BACKGROUND

• 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.

  PMID: 18038133 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.

  PMID: 16007423 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.

  PMID: 15299068 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.

  PMID: 25520903 BACKGROUND

Study Officials

• Hannu T Aro, MD, PhD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Intra-individual comparison of two diagnostic PET imaging tracers

Study Record Dates

• First Submitted: September 19, 2013
• First Posted: October 28, 2013
• Study Start: October 1, 2012
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: August 3, 2017

Record last verified: 2017-08

Locations

FI (1)