A Population-based Cohort of Osteoarthritis: the Xiangya Osteoarthritis Study

Central South University

Status: Active, not recruiting

Conditions: Osteoarthritis

Study type: Observational

Funder types: Other

Identifiers

NCT04033757

201510506

Details and patient eligibility

About

The purpose of this study is to examine the natural history, phenotypes and risk factors of osteoarthritis (OA) and pain at different joints, and to examine the association between OA structure changes, inflammation and pain for knee and hand OA.

Full description

Objectives:

1. To understand the natural history of osteoarthritis (OA) at different joints (knee, hip, hand, foot and lumbar).
2. To identify different phenotypes of OA (e.g., generalized OA, rapidly progressive knee and hand OA, tibiofemoral OA and patellofemoral OA), their association with pain (e.g., peripheral pain, central pain, nociceptive pain and neuropathic pain) and consequences.
3. To examine risk factors of OA (lifestyle habits, nutritional, metabolic, anatomical and genetic factors, etc.) at each joint as well as multiple joints.
4. To determine the association between x-ray structure change, ultrasound synovial changes and pain and other symptoms of OA at knee and hand joints within the large-sample community-based population.
5. To predict the progression of knee and hand OA within new-onset early-stage knee and hand OA patients, and to identify the rapidly progressive knee and hand OA phenotypes and their related risk factors.
6. To investigate the association between gut microbiota and OA.
7. To investigate the association between oral microbiota and OA.

Design: This is a prospective community-based cohort study.

Participants: Subjects included in this study were a randomly selected sample of residents, aged 50 years or older from rural mountainous communities of Longshan County, Hunan Province, China. 4000 people were planned to be recruited, divided into three sub-cohorts. 1,469 participants were enrolled in sub-cohort 1 in 2015, and two follow-ups have been completed in 2016 and 2017. 1,267 participants were enrolled in sub-cohort 2 in 2018. 1,340 participants were enrolled in sub-cohort 3 in 2019. Each sub-cohort will be followed every three years regularly.

Enrollment: 4,080 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 50 years old or above
2. Residents of the randomly selected communities

Exclusion criteria

1. Inability to give informed consent
2. Terminal or mental illness
3. Pregnant women

Trial design

4,080 participants in 3 patient groups

Sub-cohort 1

Description:

1,469 participants were enrolled in 2015. Three follow-ups have been completed in 2016, 2017, and 2020. They will be asked to participate in follow-up in 2023 and 2026.

Sub-cohort 2

Description:

1,267 participants were enrolled in 2018. They will be asked to participate in follow-up in 2021, 2024, 2027, and 2030.

Sub-cohort 3

Description:

1,340 participants were enrolled in 2019. They will be asked to participate in follow-up in 2022, 2025, 2028, and 2031.