## Protocol Section
### Identification Module
**NCT ID:** NCT05659979

**Brief Title:** Comprehensive Geriatric Assessment in Knee Osteoarthritis

**Official Title:** The Role of Comprehensive Geriatric Assessment in Older Patients Affected by Knee Osteoarthritis: an Exploratory Randomized Controlled Trial

#### Organization Study ID Info
**ID:** ITA7976
#### Organization
**Class:** OTHER
**Full Name:** University of Palermo
### Status Module
#### Completion Date
**Date:** 2024-01-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-12-21

**Type:** ACTUAL

**Last Update Submit Date:** 2022-12-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-01-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-01-01

**Type:** ESTIMATED

**Status Verified Date:** 2022-12

#### Study First Post Date
**Date:** 2022-12-21
**Type:** ACTUAL
**Study First Submit Date:** 2022-12-03
**Study First Submit QC Date:** 2022-12-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Charles University, Czech Republic

**Class:** OTHER

**Name:** Ente Ospedaliero Ospedali Galliera

**Class:** OTHER

**Name:** St. Marien-Hospital Düren

**Class:** OTHER

**Name:** Erasmus University Rotterdam

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Palermo

#### Responsible Party

**Investigator Affiliation:** University of Palermo

**Investigator Full Name:** Nicola Veronese

**Investigator Title:** Dr.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

**Detailed Description:** 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 incidence of OA is rising due to the aging population and an increase in some risk factors, such as obesity. Knee OA is the most common OA localization, and symptomatic knee OA is highly prevalent among people aged over 50 years, affecting more than 250 million people worldwide.

Knee OA is a leading cause of pain in older people, and pain of the hip and knee results in physical disability and an increased risk of all-cause mortality. Hip and knee OA together are the eleventh highest contributor to global disability: the years of life lived with OA-related disability increased by 64% from 1990 to 2010 reaching 17 million. OA is a progressive disorder, with different degrees of severity, that requires long-term management with various treatment options over the course of the disease. The goals of treatment for OA are to reduce symptoms and ultimately slow disease progression, which may in turn reduce the impact of OA on the patient's mobility and quality of life, with consequent reduction in healthcare resource needs.

In 2019, the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) published recommendations for the management of knee OA in the form of a treatment algorithm that provides practical guidance for the prioritization of interventions and guides physicians through progressive, logical steps based on the severity of the knee OA signs/symptoms.

The management of knee OA is therefore 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, such as hospitalization or mortality. Moreover, CGA can be used across different settings, from primary care to hospital, with similar beneficial effects in older people. Finally, people affected by knee OA are usually affected by other medical (e.g., dementia, cardiovascular diseases, depression) and non-medical (e.g., loneliness) conditions that can limit the adherence to therapeutic approaches, therefore limiting the efficacy of the interventions suggested in knee OA.

### Conditions Module

**Conditions:**

- Osteo Arthritis Knee

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Comprehensive geriatric assessment

**Label:** Comprehensive Geriatric Assessment

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** This group will receive standard/usual care

**Label:** Controls

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Comprehensive Geriatric Assessment

**Description:** 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.

**Name:** Comprehensive geriatric assessment

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Change in pain, physical function, stiffness

**Time Frame:** Baseline, 3 months, 6 months

#### Secondary Outcomes

**Description:** Adherence to medications suggested during the first visit will be evaluated during the follow-up period using questionnaires.

**Measure:** Change in the adherence to medications

**Time Frame:** Baseline, 3 months, 6 months

**Description:** This outcome will be explored using the multidimensional prognostic index (MPI), a scale that measures eight different domains typical of older people. The sum of the calculated scores from the eight domains will be divided by 8 to obtain a final MPI risk score ranging from 0 = no risk to 1 = higher risk of mortality.

**Measure:** Change in the severity of multidimensional frailty

**Time Frame:** Baseline, 3 months, 6 months

**Description:** The short form 36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the less quality of life.

**Measure:** Change in the quality of life

**Time Frame:** Baseline, 3 months, 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

**Minimum Age:** 70 Years

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** nicola.veronese@unipa.it

**Name:** Nicola Veronese, MD

**Phone:** 0916558519

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** University of Palermo

**Name:** Nicola Veronese, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001168

- Term: Arthritis

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M12926

- Name: Osteoarthritis

- Relevance: HIGH

- As Found: Osteo Arthritis

- ID: M22168

- Name: Osteoarthritis, Knee

- Relevance: HIGH

- As Found: Osteo Arthritis Knee

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010003

- Term: Osteoarthritis

- ID: D000020370

- Term: Osteoarthritis, Knee

### Misc Info Module

- Version Holder: 2024-05-24
