OBJECTIVES: This study aimed to assess the effectiveness of Comprehensive Geriatric Assessment (CGA) compared to standard of care in improving pain, physical function, and stiffness in older adults with knee osteoarthritis (OA) over six months. Secondary outcomes included multidimensional frailty and quality of life. DESIGN: An exploratory, multicentre, randomized controlled trial (RCT). SETTING: Five European geriatric centres in Italy, Germany, Turkiye and the Czech Republic. PARTICIPANTS: Seventy older adults (mean age 76.1 ± 6.8 years; 80% female) with knee OA (Kellgren-Lawrence Grades 1-2) were randomized into two groups: CGA (n = 35) or standard of care (n = 35). INTERVENTION: The CGA group underwent a multidimensional geriatric assessment and intervention, identifying impairments and tailoring interventions accordingly, while the control group received standard of care. MAIN OUTCOME MEASURES: The primary endpoint was improvement in pain, stiffness, and functional limitations measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) over six months. Secondary outcomes included changes in multidimensional frailty (Multidimensional Prognostic Index, MPI), quality of life (SF-36), and adherence to interventions. RESULTS: The CGA group showed a non-significant improvement in total WOMAC scores (-4.49 ± 3.40, p = 0.19), with slight reductions in pain (-1.12 ± 0.96) and functional limitations (-3.26 ± 2.21). MPI slightly improved (-0.02 ± 0.04, p = 0.69), but no significant changes were observed in SF-36 scores. No falls, hospitalizations, or severe adverse events were reported. CONCLUSIONS: CGA may offer potential benefits for managing knee OA in older adults, particularly for pain and function, though statistical significance was not achieved. Larger studies with longer follow-up are warranted to confirm these findings. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05659979.

Aging Clinical Research Department 2 of Internal Medicine Center for Molecular Medicine Cologne Faculty of Medicine University of Cologne University Hospital Cologne Cologne Germany

Cologne Excellence Cluster on Cellular Stress Responses in Ageing Associated Diseases University of Cologne Cologne Germany

Department of Geriatric Medicine Faculty of Medicine Bezmialem Vakif University Adnan Menderes Bulvarı Vatan Street 34093 Fatih Istanbul Turkey

Department of Geriatrics and Internal Medicine 1st Faculty of Medicine Charles University Prague Czech Republic

Department of Interdisciplinary Medicine University of Bari Aldo Moro Bari Italy

Department of Precision and Regenerative Medicine and Ionian Area Clinica Medica Augusto Murri University of Bari Aldo Moro Bari Italy

Faculty of Health and Social Sciences University of South Bohemia České Budějovice Czech Republic

Faculty of Medicine Saint Camillus International University of Health Sciences Rome Italy

Research Development and Scientific Coordination Unit National Reference High Specialization Hospital E O Galliera Hospitals Genoa Italy

Unit of Geriatrics Department of Internal Medicine and Geriatrics University of Palermo Palermo Italy

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ClinicalTrials.gov
NCT05659979