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临床试验/NCT05659979
NCT05659979尚未招募不适用

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

University of Palermo0 个研究点目标入组 30 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
Change in pain, physical function, stiffness

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

结局指标

主要结局

Change in pain, physical function, stiffness

时间窗: Baseline, 3 months, 6 months

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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicola Veronese

Dr.

University of Palermo

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