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TOwards Precision TREATment for advanced osteoarthritis: the TopTreat cohort

TOwards Precision TREATment for advanced osteoarthritis: the TopTreat cohort - TopTreat cohort

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51540
Enrollment
500
Registered
2022-10-06
Start date
2025-01-10
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Osteoarthritis - degenerative joint disease

Interventions

None listed

Sponsors

Sint Maartenskliniek
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Clinical diagnosis of knee or hand OA OA related complaints and/or radiographic modifications in at least one other joint group Pain during movement assessed on a NRS >= 3 Age >= 18 years and

Exclusion criteria

Exclusion criteria: Insufficient understanding of the Dutch language Current pregnancy or planned pregnancy during follow-up Immune-mediated inflammatory disease (IMID) of the joints Any other condition that can interfere with the assessment of mobility Scheduled for joint replacement surgery, arthrodesis or osteotomy at the time of inclusion Joint replacement surgery in the past Self-reported diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) criteria

Design outcomes

Primary

MeasureTime frame
1) Subgroups potentially requiring different treatment approaches will be identified by, amongst others, characteristics reflecting systemic low-grade inflammation (blood sample parameters, comorbidities). 2) Subgroups following different trajectories will be identified by changes in pain, physical function and Patients Global Assessment (PGA) from baseline to the 36 month visit. 3) Predictors of trajectories will be evaluated using patient related characteristics (age, sex, height, weight, waist circumference, marital status, household, education level, employment, occupation, income), clinical information (American College of Rheumatology (ACR) criteria for hand and knee OA, Kellgren Lawrence (K&L) score, Numeric Rating Scale (NRS) pain, index joint, concomitant therapy, primary or secondary OA, duration of complaints, number of affected joints, comorbidities, medication use), lifestyle characteristics (level of activity, sedentary lifestyle, alcohol consumption, smoking status), psychosocial characteristics (social participation, health literacy, self-efficacy, social support, anxiety, depression, fatigue), disease related characteristics (pain, function, PGA) and mobility. 4) Identifying statistically or clinically relevant changes in real-world mobility with smartwatch data. We will collect the cadence (steps per minute) of each of the identified walking bouts.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)