NCT03015688

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 .

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

2.6 years

First QC Date

January 6, 2017

Last Update Submit

January 9, 2017

Conditions

Keywords

Biomarkers

Outcome Measures

Primary Outcomes (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

    3 years

Study Arms (2)

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

Interventions

x-ray imagesRADIATION
Controlknee OA

Eligibility Criteria

Age38 Years - 78 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 6, 2017

First Posted

January 10, 2017

Study Start

June 1, 2012

Primary Completion

January 1, 2015

Study Completion

June 1, 2015

Last Updated

January 10, 2017

Record last verified: 2017-01