NCT02924662

Brief Summary

Studies have reported that the patient's psychological state such as anxiety, depression and other emotion affect the therapeutic effect of osteoarthritis, also may be the important reason for the poor knee joint osteoarthritis efficacy. The aim of this study are firstly to investigate the depression status of patients with osteoarthritis. Secondly, the study will aim to assess whether osteoarthritis progression will affect depression status, ultimately, provide reference for clinical.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Last Updated

October 5, 2016

Status Verified

October 1, 2016

Enrollment Period

5 months

First QC Date

October 4, 2016

Last Update Submit

October 4, 2016

Conditions

Depression

Outcome Measures

Primary Outcomes (3)

  • Western Ontario and McMaster OA index (WOMAC)

    Day 1

  • American knee society knee score

    Day 1

  • Hamilton Depression Scale-17（HAMD-17）

    Day 1

Study Arms (4)

Kellgren and Lawrence classification I

Grade I Kellgren and Lawrence radiographic changes.

Other: There is no intervention.

Kellgren and Lawrence classification II

Grade II Kellgren and Lawrence radiographic changes.

Kellgren and Lawrence classification III

Grade III Kellgren and Lawrence radiographic changes.

Kellgren and Lawrence classification IV

Grade IV Kellgren and Lawrence radiographic changes.

Interventions

There is no intervention.OTHER
Kellgren and Lawrence classification I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study group will be taken from a single centre. The patient population will be patients who are diagnosed with osteoarthritis. Participants will have a comprehensive and detailed assessment by a qualified doctor. After the assessment，the participants who are diagnosed with osteoarthritis and conformed to fit the eligibility criteria will be invited to join the investigation.

You may qualify if:

  • Meet the 1986 American College of Rheumatology (ACR) clinical criteria for knee osteoarthritis and the 2010 Chinese Medical Association clinical criteria for knee osteoarthritis.

You may not qualify if:

  • Patients with rheumatoid arthritis patients with a history of depression before osteoarthritis pathogenesis patients who can't cooperate with related inspection and assessment Patients with mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 4, 2016

First Posted

October 5, 2016

Study Start

October 1, 2016

Primary Completion

March 1, 2017

Last Updated

October 5, 2016

Record last verified: 2016-10