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

NCT ID: NCT04033757

Last Updated: 2022-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

4080 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-17

Study Completion Date

2031-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sub-cohort 1

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.

No interventions assigned to this group

Sub-cohort 2

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

No interventions assigned to this group

Sub-cohort 3

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nottingham

OTHER

Sponsor Role collaborator

Harvard University

OTHER

Sponsor Role collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guanghua Lei, Doctor

Role: STUDY_CHAIR

Xiangya Hospital of Central South University

Locations

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Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status

Countries

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China

References

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Zhu Y, Li J, Zhang Y, Zhang W, Doherty M, Yang Z, Cui Y, Zeng C, Lei G, Yang T, Wei J. Association between hyperuricaemia and hand osteoarthritis: data from the Xiangya Osteoarthritis Study. RMD Open. 2023 Dec 1;9(4):e003683. doi: 10.1136/rmdopen-2023-003683.

Reference Type DERIVED
PMID: 38053456 (View on PubMed)

Other Identifiers

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201510506

Identifier Type: -

Identifier Source: org_study_id

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