M65
Conditions
Interventions
Group 1: In healthy male participants, the elbow, knee, and ankle joints are examined at a single time point using standardized ultrasound and clinical joint examinations. In addition, three standardi
Sponsors
Universtätsklinikum Bonn
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: o Submission of written consent to participate in the study
Exclusion criteria
Exclusion criteria: o Individuals with acute (within the last 6 months) clinically significant joint pain or swelling. o Individuals suffering from any of the following conditions: - Blood clotting disorder - Osteoarthritis - Any rheumatic disease - Individuals who have undergone any of the following previous surgeries: - Arthroscopy - Ligament reconstructions / ligament ruptures - Meniscus injuries - Joint replacement surgery o Regular long-term NSAID therapy o Intra-articular injections in the past 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirmation of synovitis in at least one of the subject’s joints using the HEAD-US (a score of 1 [mild/moderate] or 2 [severe] on the Activity (Synovitis) dimension of the HEAD-US, as described by Martinoli et al. 2013). | — |
Secondary
| Measure | Time frame |
|---|---|
| Power Doppler ultrasound according to the OERACT scoring system in cases of synovitis as determined by HEAD-US. Grade 0 (no signal); Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe) (D’Agostino et al. 2017). o Pain interference (PROMIS-29) - (score 8–40 points - converted to a T-score / Numerical Rating Scale (NRS) 0–10). o Subjective physical performance (Haemophilia Activities List) - (score 0–100) - higher scores indicate better functional status. o Clinical joint examination according to De la Corte-Rodriguez et al. (swelling, pain, hemarthrosis in the past 6 months) [21] - (Score 0–124) - a higher score indicates worse joint status. o Joint damage confirmed in the cartilage (0–4) or bone (0–2) dimensions with a minimum HEAD-US score of =1 according to Martinoli et al. 2013. o Complete evaluation of the HEAD-US examination, which includes the extent of synovitis, effusion, cartilage, and bone. Individual and joint-based subgroup analyses are performed to examine the four dimensions according to Martinoli et al. 2013. o General medical history questionnaire (medical conditions, pain medications, surgeries) o Radiological confirmation in the event of synovitis and subsequent evaluation by the Department of Orthopedics and Trauma Surgery, as well as further diagnostic testing at the Department of Diagnostic and Interventional Radiology, if necessary | — |
Countries
Germany
Contacts
Public ContactAndreas Strauss
Universtätsklinikum Bonn
Outcome results
None listed