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the New Biomarker of the Knee Osteoarthritis Knee Osteoarthritis Occurrence and Progression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03015688
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):
Jianwei He, Shihezi University

Tracking Information
First Submitted Date January 6, 2017
First Posted Date January 10, 2017
Last Update Posted Date January 10, 2017
Study Start Date June 2012
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 9, 2017)
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 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title the New Biomarker of the Knee Osteoarthritis Knee Osteoarthritis Occurrence and Progression
Official Title Not Provided
Brief 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. 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 .
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Probability Sample
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.

Condition Knee Osteoarthritis
Intervention Radiation: x-ray images
Study Groups/Cohorts
  • 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.
    Intervention: 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,
    Intervention: Radiation: x-ray images
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 9, 2017)
460
Original Actual Enrollment Same as current
Actual Study Completion Date June 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • OA diagnosis was on the basis of the diagnosis and treatment guideline of the American Academy of Orthopedic Surgeons

Exclusion Criteria:

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 38 Years to 78 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03015688
Other Study ID Numbers 2012-06-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jianwei He, Shihezi University
Study Sponsor Shihezi University
Collaborators Not Provided
Investigators Not Provided
PRS Account Shihezi University
Verification Date January 2017