Comprehensive Geriatric Assessment in Knee Osteoarthritis

NCT05659979 | Unknown

• 1 other identifier: ITA7976
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Osteoarthritis (OA) is the most common form of arthritis, and is characterized by joint pain and stiffness leading to functional decline and relevant loss in quality of life. The management of knee OA is demanded to several specialists, including general practitioners, rheumatologists, orthopedics and finally geriatricians. However, the exact role of geriatricians in the management of knee OA was poorly studied, whilst the comprehensive geriatric assessment (CGA) is widely used for preventing negative consequences in older people.

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (1)

• Change in pain, physical function, stiffness

  We will use the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale. The WOMAC, that is one of the most used tool in knee OA research, measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). The single items of the WOMAC will be assessed as co-primary outcomes.

  Baseline, 3 months, 6 months

Secondary Outcomes (3)

• Change in the adherence to medications

  Baseline, 3 months, 6 months

• Change in the severity of multidimensional frailty

  Baseline, 3 months, 6 months

• Change in the quality of life

  Baseline, 3 months, 6 months

Study Arms (2)

Comprehensive Geriatric Assessment

EXPERIMENTAL

This group will receive a comprehensive geriatric assessment evaluation during the study, using the multidimensional prognostic index

Other: Comprehensive geriatric assessment

Controls

NO INTERVENTION

This group will receive standard/usual care

Interventions

Comprehensive geriatric assessment OTHER

A detailed comprehensive geriatric assessment will be given to all the participants randomized to this group, including the administration of multidimensional prognostic index (MPI), a tool derived from the CGA and consisting of eight different domains.

Comprehensive Geriatric Assessment

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Both genders
• Age \> 70 years; able to sign the informed consent
• Diagnosis of knee OA according to standardized criteria in Grade 1 (doubtful narrowing of joint space and possible osteophytic lipping), Grade 2 (definite osteophytes and possible narrowing of joint space) Kellgren and Lawrence system or Grade 3 (moderate multiple osteophytes, definite narrowing of joint space and some sclerosis and possible deformity of bone ends).

You may not qualify if:

• Expected life expectancy less than 6 months
• Previous orthopedic surgery, in the three months before the enrolment or a planned orthopedic intervention in the next 6 months.

Sponsors & Collaborators

• University of Palermo: lead
• Charles University, Czech Republic: collaborator
• Ente Ospedaliero Ospedali Galliera: collaborator
• St. Marien-Hospital Düren: collaborator
• Erasmus University Rotterdam: collaborator

Related Publications (1)

• Veronese N, Fazzari A, Santangelo E, Iommi C, Soysal P, Custodero C, Pickert L, Polidori MC, Stolniceanu N, Michalkova H, Topinkova E, Pilotto A, Barbagallo M. The role of comprehensive geriatric assessment in older patients affected by knee osteoarthritis: an exploratory randomized controlled trial. Aging Clin Exp Res. 2025 May 16;37(1):155. doi: 10.1007/s40520-025-03061-0.

  PMID: 40377819 DERIVED

MeSH Terms

Interventions

Geriatric Assessment

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Nicola Veronese, MD

  University of Palermo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola Veronese, MD

CONTACT

0916558519; nicola.veronese@unipa.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 3, 2022
• First Posted: December 21, 2022
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share