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Is there an association between wrist or hand complaints and radiological imaging findings?

Is there an association between wrist or hand complaints and radiological imaging findings?

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON24562
Enrollment
438
Registered
2021-03-22
Start date
2021-03-22
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hand-wrist pathology

Interventions

None listed

Sponsors

Reinier de Graaf Hospital, department of orthopedic surgery and department of radiology/Erasmus Medical Center, department of general practice
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ? A new patients who will undergo a radiography of their wrist and/or hand; ? Referral to the radiology department of the RdGG for radiography; ? Age 18 years or over; ? Signed informed consent (see E2 submission request); ? Main problem concerns wrist and/or hand complaints.

Exclusion criteria

Exclusion criteria: ? Not mastering the Dutch or English language; ? Patients who have undergone imaging of their wrist and/or hand over the past 12 months because of ipsilateral complaints; ? Incapable of understanding the ramifications of participation; ? Wrist or hand infection (osteomyelitis); ? Pre-existent neurological pathology in the affected limb;

Design outcomes

Primary

MeasureTime frame
The main study endpoint is the incidence of wrist and/or hand pathologies on radiography in adult patients (= 18 year). Traumatic and non-traumatic diagnosed abnormalities on radiography at baseline are: ? wrist or hand fracture characteristics (fracture type, location); ? wrist or hand osteoarthritis characteristics (osteoarthritis score, location); ? no abnormalities (no fracture or osteoarthritis) were diagnosed by radiography examination.

Secondary

MeasureTime frame
Patient reported outcomes will be measured at baseline and 6 weeks, 3 months and 12 months after baseline. Outcomes will be measured with the Patient-Rated Wrist Hand Evaluation (PRWHE-score: see F1 submission request), Australian/Canadian Hand Osteoarthritis Index (AUSCAN: see F1 submission request), Numeric Pain Rating Scale-score (NPRS: see F1 submission request), Pain Catastrophizing Scale (PCS: see F1 submission request), Hospital Anxiety and Depression Scale (HADS: see F1 submission request), Patients Perceived Recovery and Outcome (see page 17) and the modified version of the Functional Comorbidity Index (FCI: see F1 submission request) ? Severity of symptoms (pain) of wrist or hand (PRWHE, AUSCAN and NPRS) at all time points (baseline, 6 weeks, 3 months and 12 months); ? Functional impairment of wrist or hand (PRWHE and AUSCAN) at all time points (baseline, 6 weeks, 3 months and 12 months); ? PCS and HADS will be completed at all time points (baseline, 6 weeks, 3 months and 12 months) to determine psychological factors related with the outcome; ? The modified version of the FCI will be completed at baseline to determine comorbidity; ? Patients-Perceived Recovery and Outcome will be measured at 6 weeks, 3 months and 12 months to determine perception of recovery. In addition to the questionnaires, we will score additional outcomes. ? Rare abnormalities: anatomical variants, congenital deformations, abutments syndromes, rheumatoid arthritis, hemochromatosis, gout tophi, psoriatic arthritis, bone deformities (osteomalacia, Swann neck deformity, Boutonniere deformity); ? Neoplasia, benign tumors (chondrosarcoma, osteosarcoma, enchondroma, metastatic cancer) and malignant tumors;

Contacts

Public ContactOnderzoek RHOC

Reinier Haga Orthopedisch Centrum

Onderzoek@rhoc.nl+31(0)79 206 5595

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)