Knee OsteoarthritisNCT03015688
the New Biomarker of the Knee Osteoarthritis Knee Osteoarthritis Occurrence and Progression
An observational study of Knee Osteoarthritis, run by Shihezi University.
Trial summary
It was previously proved an association of TGF-β1 and PDGF-BB with the pathogenesis of osteoarthritis (OA) by experiments of OA animal models. In this study, we aimed to determine whether serum concentrations of TGF-β1, PDGF-BB and CTX-1 were related to the knee OA. Read more about this study
- Who is it for?
- Ages 38 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- x-ray images
- Type of treatment
- Surgery or procedure
- How many people
- 460 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Jun 2015
- How long will I take part?
- 1 Year
- 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 38 to 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 210 patients diagnosed with knee OA in clinics were found in hospital patients . Healthy controls were recruited from community questionnaires in Shihezi city, Xinjiang province, China.
Who may be able to join
- OA diagnosis was on the basis of the diagnosis and treatment guideline of the American Academy of Orthopedic Surgeons
Who cannot join
- Participants who met the following criteria were excluded：
- the knee OA concomitant with hip OA,
- suppurative and rheumatoid arthritis,
- gout patients,
- patients who underwent knee arthroscopy surgery within 6 months,
- bilateral or unilateral knee replacements,
- the knee joint trauma patients,
- histories of glucocorticoid and/or sterol hormones.
About this study
It was previously proved an association of TGF-β1 and PDGF-BB with the pathogenesis of osteoarthritis (OA) by experiments of OA animal models. In this study, we aimed to determine whether serum concentrations of TGF-β1, PDGF-BB and CTX-1 were related to the knee OA. knee OA cases were collected from the first affiliated hospital of Shihezi university and healthy controls were recruited from the community. The severity of knee OA was defined as kellgren-lawrence (K-L) classification criteria.Serum levels of chemical biomarkers were compared between knee OA cases and controls or among K-L grade 2 to grade 4 groups. The serum concentrations of the TGF-β1, PDGF-BB and CTX-1 were determined by ELISA .
- Conditions
- Knee Osteoarthritis
- Being tested
- x-ray images
- Keywords
- Biomarkers
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
x-ray imagesRadiation
| Study group | Role | What they receive |
|---|---|---|
| knee OA | OA diagnosis was on the basis of the diagnosis and treatment guideline of the American Academy of Orthopedic Surgeons Participants who met the following criteria were excluded：the knee OA concomitant with hip OA, suppurative and rheumatoid arthritis, gout patients, patients who underwent knee arthroscopy surgery within 6 months, bilateral or unilateral knee replacements, the knee joint trauma patients, histories of glucocorticoid and/or sterol hormones. Receives: Radiation: x-ray images | |
| Control | "no often have pain, aching or stiffness in your Left/right knee during last month","no Left/right knee trauma history","no histories of glucocorticoid and/or sterol hormones" normal knee X-ray images, Receives: Radiation: x-ray images |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of Transforming Growth Factor Beta1 (TGF-β1) and Platelet Derived Growth Factor BB (PDGF-BB) may be novel biomarkers in knee osteoarthritis
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startJun 2012
- Primary completionJan 2015
- Study completionJun 2015
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.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 460 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shihezi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianwei He, Shihezi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015688
- Sponsor's protocol ID
- 2012-06-01
- Status last verified
- Jan 2017
- First submitted
- 6 Jan 2017
- Last updated
- 10 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the New Biomarker of the Knee Osteoarthritis Knee Osteoarthritis Occurrence and Progression
- ClinicalTrials.gov ID
- NCT03015688
- Acronym / sponsor ID
- 2012-06-01
- Conditions
- Knee Osteoarthritis
- Keywords
- Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Shihezi UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Jan 2017 (estimated)
- 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.
It was previously proved an association of TGF-β1 and PDGF-BB with the pathogenesis of osteoarthritis (OA) by experiments of OA animal models. In this study, we aimed to determine whether serum concentrations of TGF-β1, PDGF-BB and CTX-1 were related to the knee OA. knee OA cases were collected from the first affiliated hospital of Shihezi university and healthy controls were recruited from the community. The severity of knee OA was defined as kellgren-lawrence (K-L) classification criteria.Serum levels of chemical biomarkers were compared between knee OA cases and controls or among K-L grade 2 to grade 4 groups. The serum concentrations of the TGF-β1, PDGF-BB and CTX-1 were determined by ELISA .
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| knee OA | – | Radiation: x-ray imagesOA diagnosis was on the basis of the diagnosis and treatment guideline of the American Academy of Orthopedic Surgeons Participants who met the following criteria were excluded：the knee OA concomitant with hip OA, suppurative and rheumatoid arthritis, gout patients, patients who underwent knee arthroscopy surgery within 6 months, bilateral or unilateral knee replacements, the knee joint trauma patients, histories of glucocorticoid and/or sterol hormones. |
| Control | – | Radiation: x-ray images"no often have pain, aching or stiffness in your Left/right knee during last month","no Left/right knee trauma history","no histories of glucocorticoid and/or sterol hormones" normal knee X-ray images, |
Who may qualify
- Ages
- 38 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 210 patients diagnosed with knee OA in clinics were found in hospital patients . Healthy controls were recruited from community questionnaires in Shihezi city, Xinjiang province, China.
Key inclusion criteria (1 listed)
- OA diagnosis was on the basis of the diagnosis and treatment guideline of the American Academy of Orthopedic Surgeons
Key exclusion criteria (8 listed)
- Participants who met the following criteria were excluded：
- the knee OA concomitant with hip OA,
- suppurative and rheumatoid arthritis,
- gout patients,
- patients who underwent knee arthroscopy surgery within 6 months,
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 |
|---|---|---|
| x-ray images | Radiation | Control, knee OA |
Primary outcome
Serum levels of Transforming Growth Factor Beta1 (TGF-β1) and Platelet Derived Growth Factor BB (PDGF-BB) may be novel biomarkers in knee osteoarthritis
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Shihezi University.
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 8 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: finished, as of the sponsor's last update on 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum levels of Transforming Growth Factor Beta1 (TGF-β1) and Platelet Derived Growth Factor BB (PDGF-BB) may be novel biomarkers in knee osteoarthritis (time frame: 3 years). 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 10 Jan 2017.