NCT04951414

Brief Summary

To solve the existing Knee osteoarthritis;KOA) clinical norms and guidelines have low operability, Disconnection between treatment plan and specific evaluation results, difficulty in achieving individualized intervention and other problems, on the one hand, we need to develop Chinese expert consensus or clinical path based on evidence-based medicine to adapt to China's national conditions, on the other hand, is more important in The KOA clinical process introduces a set of tools to translate evidence-based medicine evidence into specific, actionable treatments, Thus, a more flexible, more comprehensive and three-dimensional, adaptable, targeted, more conducive to the promotion of the individual integration KOA rehabilitation intervention program.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

June 27, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

July 6, 2021

Status Verified

June 1, 2021

Enrollment Period

1.5 years

First QC Date

June 27, 2021

Last Update Submit

June 27, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • treatment compliance

    treatment compliance of rehabilitation treatment

    1month

  • treatment compliance

    treatment compliance of rehabilitation treatment

    3month

  • treatment compliance

    treatment compliance of rehabilitation treatment

    6month

Study Arms (2)

ICF

Diagnostic Test: ICF core set

Control

Interventions

ICF core setDIAGNOSTIC_TEST

KOA rehabilitation regimen based on the complete core combination of ICF was accepted

ICF

Eligibility Criteria

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

Six hundred patients with knee osteoarthritis were treated in each participating research unit

You may qualify if:

  • Neither knee had undergone knee replacement, and no knee replacement had been performed in recent half a year planning to have a knee replacement; Volunteered to participate in the study and signed the informed consent.

You may not qualify if:

  • People with consciousness disorder, cognitive disorder, severe mental illness, unable to accurately express their own will, or unable to cooperate with the completion of various assessments and treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Capital clinical characteristic applied research and achievement promotion

Beijing, Beijing Municipality, 100191, China

RECRUITING

Huarunwugang general hospital

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • YUANMINGFEI ZHANG

    Peking University Third Hospital

    STUDY DIRECTOR

Central Study Contacts

YUANMINGFEI ZHANG

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2021

First Posted

July 6, 2021

Study Start

July 1, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

July 6, 2021

Record last verified: 2021-06

Locations