Longitudinal Leiden Orthopaedics Outcomes of OsteoArthritis Study

Longitudinal Leiden Orthopaedics Outcomes of OsteoArthritis Study - LOAS

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55690

Enrollment

17000

Registered

2012-02-14

Start date

2012-06-01

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

degenerative joint disease osteoarthritis

Interventions

n.v.t.&nbsp

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Patients, who are scheduled for primary total hip, total knee or shoulder arthroplasty surgery or revision surgery • Are able to complete questionnaires, either on paper or electronically •Patients > 18 years of age

Exclusion criteria

Exclusion criteria: • No informed consent signed or electronic informed consent provided • Insufficient Dutch language skills • Physical or mental status not allowing participation

Design outcomes

Primary

Measure	Time frame
Assessments will be done at baseline (pre-operatively), 3, 6, 12, and 24 months postoperatively and every 2 years thereafter until 10 years post-surgery. Main outcome parameters are: NRS pain at rest and during physical activity, knee, hip or shoulder functioning (HOOS-PS/KOOS-PS and Oxford Hip/Knee/Shoulder Score); Sleep quality (Pitsburg Sleep Quality Index (PSQI)), PROMIS physical (Mobility/Upper Extremity) and Cognitive Function; physical activity (Dutch Norm of Healthy Exercise / Fitstandard); work status; Quality of life (SF-12 and EQ-5D); patient satisfaction; health care usage; radiological outcome (post-operative femorotibial angle (knee); alignment of the stem, inclination of the cup (Hip); alignment and orientation of the humeral stem and glenoid., three anchor questions on outcome (Likert scale 0-4) and post-operative complications (including progression of osteoarthritis in other joints and venous thromboembolism). Main potential determinants of outcome are: sociodemographic characteristics (age, sex); comorbidities (comorbidity questionnaire, Charnley classification and ASA classification); frailty (>70 years of age: Groningen Frailty Index); pre-operative use of pharmacological and non-pharmacological treatment for hip, knee or shoulder pain; outcome expectations (Credibility / Expectancy Questionnaire); preoperative radiographic osteoarthritisdamage (Kellgren score (hip, knee and shoulder), femorotibial angle and alignment of the stem and inclination of the cup (hip) and for the shoulder the Walch score, acromio-humeral distance and rotator cuff status will be measured. patient and surgery characteristics which could predict postoperative complications, (risk factor questionnaires).	—

Measure

Time frame

Assessments will be done at baseline (pre-operatively), 3, 6, 12, and 24 months postoperatively and every 2 years thereafter until 10 years post-surgery. Main outcome parameters are: NRS pain at rest and during physical activity, knee, hip or shoulder functioning (HOOS-PS/KOOS-PS and Oxford Hip/Knee/Shoulder Score); Sleep quality (Pitsburg Sleep Quality Index (PSQI)), PROMIS physical (Mobility/Upper Extremity) and Cognitive Function; physical activity (Dutch Norm of Healthy Exercise / Fitstandard); work status; Quality of life (SF-12 and EQ-5D); patient satisfaction; health care usage; radiological outcome (post-operative femorotibial angle (knee); alignment of the stem, inclination of the cup (Hip); alignment and orientation of the humeral stem and glenoid., three anchor questions on outcome (Likert scale 0-4) and post-operative complications (including progression of osteoarthritis in other joints and venous thromboembolism). Main potential determinants of outcome are: sociodemographic characteristics (age, sex); comorbidities (comorbidity questionnaire, Charnley classification and ASA classification); frailty (>70 years of age: Groningen Frailty Index); pre-operative use of pharmacological and non-pharmacological treatment for hip, knee or shoulder pain; outcome expectations (Credibility / Expectancy Questionnaire); preoperative radiographic osteoarthritisdamage (Kellgren score (hip, knee and shoulder), femorotibial angle and alignment of the stem and inclination of the cup (hip) and for the shoulder the Walch score, acromio-humeral distance and rotator cuff status will be measured. patient and surgery characteristics which could predict postoperative complications, (risk factor questionnaires).

—

Countries

Netherlands

Contacts

Public ContactM.G.J. Gademan

Leids Universitair Medisch Centrum

m.g.j.gademan@lumc.nl+31-(0)71-5263606

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)