The Orienting Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorI.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
About this trial
This study at IRCCS Galeazzi - Sant'Ambrogio Hospital involves patients with gout, CPPD, and osteoarthritis as a control group. Patients will receive routine care with regular clinical, laboratory, and imaging assessments every six months, alongside urgent visits as needed. The study aims to understand crystal deposits in joints and blood vessels and monitor their progression over time, assessing how these deposits respond to standard treatments and if they are associated with cardiovascular complications. Data will be collected from medical records over a follow-up period of up to 10 years, offering long-term insights into disease impact and treatment effectiveness.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with CPPD disease according to the ACR/EULAR 2023 classification criteria.
Patients with evidence of asymptomatic CPPD on US or X-rays (not meeting the classification criteria) according to validated imaging definitions.
Aged older than 18 years.
Able to provide informed consent, according to requirements of local IRB/ethics committee.
Disqualifiers
Known history of other inflammatory arthropathies
Unable to provide informed consent, according to requirements of local IRB/ethics committee.
Known history of other inflammatory arthropathies
Unable to provide informed consent, according to requirements of local IRB/ethics committee.
Trial population
Patients affected by gout, CPPD or osteoarthritis.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
450 Participants
are grouped into 3 trial groupsGroup A: Gout
Group B: CPPD
Group C: Disease control
Trial outcomes
Primary outcomes
1
Extent of CPP crystal deposition assessed by ultrasound over time
Calcium pyrophosphate crystal deposition (CPPD) will be assessed using the OMERACT Ultrasound Scoring System for CPPD at patient level and at joint level. Each anatomical site will be graded on a semi-quantitative scale from 0 to 3. According to the clinical scenario and the clinician decision, patients will undergo an US examination of the affected joints. Case by case the following joints will be evaluated: shoulder, elbow, wrist, hand, hip, knee, ankle, Achilles tendon, foot. The total score will be calculated as the sum of scores across all evaluated sites and normalized by the number of sites assessed per patient. The measure will be assessed longitudinally to evaluate changes in crystal deposition over time.
Time frame
Baseline and every 6 months up to 10 years2
Extent of MSU crystal deposition assessed by ultrasound over time
Assessment of the extent of monosodium urate (MSU) crystal deposition Calcium pyrophosphate crystal deposition (CPPD) will be assessed using the OMERACT Ultrasound Scoring System for Gout Lesions (double contour sign, tophi, aggregates). Each lesion will be graded on a semi-quantitative scale from 0 to 3. A total score will be calculated by summing scores across all evaluated joints. According to the clinical scenario and the clinician decision, patients will undergo an US examination of the affected joints. Case by case the following joints will be evaluated: shoulder, elbow, wrist, hand, hip, knee, ankle, Achilles tendon, foot. The total score will be calculated as the sum of scores across all evaluated sites and normalized by the number of sites assessed per patient. The measure will be assessed longitudinally to evaluate changes in crystal deposition over time.
Time frame
Baseline and every 6 months up to 10 years3
Progression of bone erosions assessed by ultrasound
Bone erosions will be assessed using the OMERACT Ultrasound Scoring System for Bone Erosions. Each site will be graded from 0 to 3 and summed across all evaluated joints to obtain a total erosion score. The measure will be assessed longitudinally to evaluate changes over time.
Time frame
Baseline and every 6 months up to 10 years4
Progression of osteophites assessed by ultrasound
Osteophytes will be assessed using the OMERACT Ultrasound Scoring System for Osteophytes. Each site will be graded from 0 to 3 and summed across all evaluated joints to obtain a total osteophyte score. The measure will be assessed longitudinally to evaluate changes over time.
Time frame
Baseline and every 6 months up to 10 yearsSecondary outcomes
1
ESR
Change From Baseline in Erythrocyte Sedimentation Rate (ESR mm/h) between patients with CPPD and gout and disease-controls with OA
Time frame
From baseline every 6 months up to 10 years2
CRP
Change From Baseline in C-Reactive Protein (CRP mg/L) between CPPD and Gout patients and controls with OA
Time frame
From baseline every 6 months up to ten years3
Synovitis Score Assessed by Global OMERACT-EULAR Synovitis Score (GLOESS)
Synovitis will be evaluated thanks to Global OMERACT-EULAR Synovitis Score (GLOESS). Ultrasound evaluation will be performed on clinically relevant joints and anatomical structures as determined by the treating physician.
Time frame
Baseline and every 6 months up to 10 years4
Tenosynovitis Score Assessed by OMERACT Ultrasound Scoring System
Tenosynovitis will be assessed using the OMERACT ultrasound scoring system on a semi-quantitative scale. Ultrasound evaluation will be performed on clinically relevant joints and anatomical structures as determined by the treating physician.
Time frame
Baseline and every 6 months up to 10 yearsOther outcomes
1
Serum suPAR Levels Assessed by Enzyme Immunoassay
Serum soluble urokinase plasminogen activator receptor (suPAR) levels will be measured using an ELISA-based assay on blood and/or synovial fluid, whenever the patients undergo arthrocentesis for other reasons
Time frame
Once during the 10 years follow up2
Intima media thickness at ultrasound of carothid arteries
Measurment of intima-media thickness (CMIT) at ultrasound of carothid arteries performed as part of routine care will be collected to assess increased atherosclerotic risk. The European Society of Cardiology (ESC) often highlights CMIT\> 0.9 as a critical threshold to determine an increased risk
Time frame
As clinically indicated during follow-up up to ten years from baseline3
Assessment of joint damage using X-ray, CT or MRI
On radiographs and CT, osteoarthritis severity will be evaluated based on osteophytes, joint space narrowing, and subchondral bone changes, using a semi-quantitative grading scale (e.g., Kellgren-Lawrence grade 0-4 for radiographs). On MRI, joint damage will be assessed including cartilage integrity and other structural abnormalities using appropriate semi-quantitative scoring systems (WORMS, MOAKS)
Time frame
As clinically indicated during follow-up from baseline up to ten years4
Histological and Molecular Characteristics of Joint Tissues in Patients Undergoing Arthroplasty
Biological samples (bone, cartilage, synovial membrane, ligaments/tendons, synovial fluid) collected during clinically indicated arthroplasty procedures will be analyzed using histology, immunohistochemistry, and Raman spectroscopy to assess tissue morphology, inflammatory features, and crystal deposition.
Time frame
At time of surgery (as applicable)Sponsors and contacts
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Source ClinicalTrials.gov