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

Knee Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03015688
• Other study ID #: 2012-06-01
• Status: Completed
• Phase: N/A
• First received: January 6, 2017
• Last updated: January 9, 2017
• Start date: June 2012
• Est. completion date: June 2015

Study information

• Verified date: January 2017
• Source: Shihezi University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical 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. 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: June 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 38 Years to 78 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Radiation:
• x-ray images

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shihezi University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum levels of Transforming Growth Factor Beta1 (TGF-ß1) and Platelet Derived Growth Factor BB (PDGF-BB) may be novel biomarkers in knee osteoarthritis		3 years	Yes