Validation of Handheld Ultrasound Devices in Rheumatology
NCT Number: NCT06580886
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Psoriatic Arthritis
Interventions: DEVICE: Ultrasound
Sponsor: Ottawa Hospital Research Institute
Collaborators: University of Florida|University Health Network, Toronto|Novartis
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-16
Completion Date: 2024-06-28
Locations: University of Florida College of Medicine, Gainesville, Florida, 32610, United States|Ottawa Hospital Research Institute, Ottawa, Ontario, K1H 8L6, Canada|Women's College Research Institute, Toronto, Ontario, M5S 1B2, Canada

Summary:
The goal of this clinical trial is to test the concurrent validity of the Clarius handheld ultrasound devices versus gold-standard device to detect characteristic features of healthy and rheumatic joints in adults Psoriatic Arthtritis patients (i.e. anatomical structures and vascular flow).

Primary Outcome Measures: Intraarticular synovitis scoring, After the imaging of all patients is completed, intraarticular synovitis scoring will be done based on the OMERACT definitions (scales of 0-3) as follows.

Greyscale inflammatory (hypoechoic) synovial hyperplasia:

Grade 0: no hypoechoic synovial hyperplasia Grade 1: minimal hypoechoic synovial hyperplasia (filling the angle between the periarticular bones, without bulging over the line linking tops of the bones) Grade 2: hypoechoic synovial hyperplasia bulging over the line linking tops of the periarticular bones but without extension along the bone diaphysis Grade 3: hypoechoic synovial hyperplasia bulging over the line linking tops of the periarticular bones and with extension to at least one of the bone diaphysis, 6 months
Secondary Outcome Measures: Intraarticular Doppler scoring, After the imaging of all patients is completed, the intraarticular Doppler scoring will be done based on the OMERACT definitions (scales of 0-3).

Power Doppler signal:

Grade 0: no flow in the hypoechoic synovial hyperplasia Grade 1: up to three single spots signals or up to two confluent spots or one confluent spot plus up to two single spots Grade 2: vessel signals in less than half of the area of the synovium (≤50%) Grade 3: vessel signals in more than half of the area of the synovium (\>50%)

Also, a lateral view of the 2nd metacarpophalangeal and 5th metatarsophalangeal joints will be recorded in the baseline visit for erosion assessment. Erosions will be described as intra-articular discontinuity of the bony surface seen in 2 perpendicular planes and will be evaluated after the imaging of all patients is completed., 6 months|Assessment of nail images, B mode and doppler images of the 2nd nail or most involved nail with all probes (Clarius L20, GE Logic E9/S8) will be recorded in the baseline visit. The loss of the trilaminar appearance and the presence of doppler signal in the nail will be evaluated after the imaging of all patients is completed. During imaging of the nail, if any Doppler signal is detected in nail bed, regardless of its severity, the presence of Doppler signal will be considered positive., 6 months|Assessment of tendon images, B mode and Doppler images of the tibialis posterior tendon with Clarius L15 and GE Logic E9/S8 will be recorded in the baseline visit. The presence of tendonitis, tenosynovitis and intratendinous Doppler signal in tibialis posterior tendon will be evaluated after the imaging of all patients is completed.

B mode and Doppler images of the 2nd extensor digitorum tendon with Clarius L20 and GE Logic E9/S8 will be recorded in the baseline visit. The presence of paratenonitis and intratendinous Doppler signal in the extensor digitorum tendon will be evaluated after the imaging of all patients is completed., 6 months|Assessment of entheses images, Elementary lesions of enthesitis will be defined and scored as per the GRAPPA US working group's definitions, as used in the multicenter DUET study.

All of the elementary lesions will be assessed for their presence or absence. In addition, some of the lesions will also be scored for their severity using a semiquantitative system (grade 0 to 3). The definitions of each grade are outlined below.

• Hypoechogenicity: Grade 0: Absent Grade 1: Present

• Thickening: Grade 0: Absent Grade 1: Present

• Bone Erosion: Grade 0: Absent Grade 1: Present

• Enthesophyte: Grade 0: No enthesophytes Grade 1: Small enthesophyte Grade 2: Medium enthesophyte Grade 3: Large enthesophytes

• Calcification: Grade 0: No calcifications Grade 1: Punctate hyperechoic area Grade 2: Linear calcification without acoustic shadow Grade 3: Egg-shell calcification with posterior acoustic shadow

• Doppler Signal: Grade 0: No Doppler signal Grade 1:A single confluent Doppler signal or, 6 months
Other Outcome Measures: Adverse event, Adverse events will be recorded during scanning., 6 months