About this trial
The aim of this observational study is to investigate the relationship between pain severity and alterations in bone-derived and brain-derived signaling molecules (including serum neurotransmitters and inflammatory cytokines), as well as structural and functional changes in the ventrolateral periaqueductal gray (vlPAG) region in patients with kidney-deficiency type knee osteoarthritis (KOA). The central question it seeks to address is whether changes in these signaling molecules and vlPAG alterations are associated with the degree of pain.
Patients scheduled to undergo total knee arthroplasty (TKA) due to KOA will be enrolled prior to surgery. Before the operation, they will undergo questionnaire assessments, physical examinations, imaging evaluations, and blood sample collection. The resected tibial plateau tissue obtained during surgery will be used for subsequent laboratory analyses.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Clinical diagnosis of KOA
Age between 60-70 years.
Kellgren-Lawrence grade IV on anteroposterior and lateral knee X-rays.
Scheduled for total knee arthroplasty.
Disqualifiers
Clinical diagnosis of ankylosing spondylitis, rheumatoid arthritis, gout, or other related conditions.
Presence of metabolic bone diseases, acute trauma, malignancies, infections, or other complications severely affecting knee function.
Use of drugs affecting bone metabolism (e.g., corticosteroids, zoledronic acid) within the past 6 months.
Presence of psychiatric disorders or serious cardiovascular, pulmonary, renal, hepatic, hematologic, or other systemic diseases.
Trial population
Patients with knee osteoarthritis of kidney deficiency type from the Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine. And the healthy volunteers recruited by the research team.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
The WOMAC Index is a validated instrument used to assess pain, stiffness, and physical dysfunction in patients with osteoarthritis. It comprises 3 subscales with a total of 24 items, yielding a total score ranging from 0 to 96, where higher scores indicate more severe symptoms and greater functional impairment.
Secondary outcomes
Visual Analog Scale (VAS) score
The VAS score is a subjective measure used to assess pain intensity, typically presented as a continuous scale ranging from 0 to 10, with higher scores indicating greater pain severity.
Pattern Element Analysis
A pattern differentiation system would be used to assess the severity of kidney-deficiency-related pathological changes.
Function of Knee Joint
Gait analysis and neutral position (0°) method to evaluate knee joint function.
Volume of Subchondral Cystic Lesions
Knee MRI combined with Mimics software would be used to calculate the volume of subchondral cystic lesions.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jinchao Xu
Lead sponsor
Fujian University of Traditional Chinese Medicine
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options: