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

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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

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 .

Condition or disease Intervention/treatment
Knee Osteoarthritis Radiation: x-ray images

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Study Type : Observational [Patient Registry]
Actual Enrollment : 460 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Year
Study Start Date : June 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: X-Rays

Group/Cohort Intervention/treatment
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.
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,
Radiation: x-ray images



Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   38 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.
Additional Information:

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Responsible Party: Jianwei He, Principal investigator, Shihezi University
ClinicalTrials.gov Identifier: NCT03015688    
Other Study ID Numbers: 2012-06-01
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Keywords provided by Jianwei He, Shihezi University:
Biomarkers
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases