Knee OsteoarthritisNCT04951414
Study on the Rehabilitation Treatment of Knee Osteoarthritis Based on ICF
An observational study of Knee Osteoarthritis, run by Peking University Third Hospital at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- ICF core set
- How many people
- 600 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Six hundred patients with knee osteoarthritis were treated in each participating research unit
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Capital clinical characteristic applied research and achievement promotion
Beijing, Beijing Municipality, 100191
Mouwang Zhou, +86 15611908378, zhoumouwang@163.com
- Recruiting
Huarunwugang general hospital
Wuhan, Hubei
Yuanmingfei Zhang, Dr., +86 15201469083, zymf@pku.edu.cn
About this study
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- ICF core set
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICF core setDiagnostic test
KOA rehabilitation regimen based on the complete core combination of ICF was accepted
| Study group | Role | What they receive |
|---|---|---|
| ICF | Not described Receives: Diagnostic Test: ICF core set | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment compliance
treatment compliance of rehabilitation treatment
Measured: 1month
treatment compliance
treatment compliance of rehabilitation treatment
Measured: 3month
treatment compliance
treatment compliance of rehabilitation treatment
Measured: 6month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start1 Jul 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YUANMINGFEI ZHANG, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951414
- Sponsor's protocol ID
- D181100000318004
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 6 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Rehabilitation Treatment of Knee Osteoarthritis Based on ICF
- ClinicalTrials.gov ID
- NCT04951414
- Acronym / sponsor ID
- D181100000318004
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICF | – | Diagnostic Test: ICF core set |
| Control | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Six hundred patients with knee osteoarthritis were treated in each participating research unit
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICF core setKOA rehabilitation regimen based on the complete core combination of ICF was accepted | Diagnostic test | ICF |
Primary outcome
treatment compliance
Time frame: 1month
treatment compliance of rehabilitation treatment
treatment compliance
Time frame: 3month
treatment compliance of rehabilitation treatment
treatment compliance
Time frame: 6month
treatment compliance of rehabilitation treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YUANMINGFEI ZHANG study director
Peking University Third Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Peking University Third Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao Li, Dr (+8613811397872, tobetheone@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment compliance (time frame: 1month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2021.