The 'Bone-Brain' Crosstalk Mechanism of Subchondral Bone Nociceptive Sensitization Activating SPP1-Positive Microglia in the vlPAG Region Elucidates the Theoretical Connotation of Treating Knee Osteoarthritis Based on Kidney Differentiation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Osteoarthitis. Basic parameters: 60 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index [Time frame: Participants were tested immediately after being included in the study.]
Secondary outcome measures (12)
- Visual Analog Scale (VAS) score [Time frame: Participants were tested immediately after being included in the study.]
- Pattern Element Analysis [Time frame: Participants were tested immediately after being included in the study.]
- Function of Knee Joint [Time frame: Participants were tested immediately after being included in the study.]
- Volume of Subchondral Cystic Lesions [Time frame: Participants were tested immediately after being included in the study.]
- Brain Region Structure [Time frame: Participants were tested immediately after being included in the study.]
- Brain Region Functional Connection [Time frame: Participants were tested immediately after being included in the study.]
- Serum Neurotransmitters [Time frame: Participants were tested immediately after being included in the study.]
- Serum Inflammatory Cytokines [Time frame: Participants were tested immediately after being included in the study.]
- Microarchitecture of Subchondral Bone [Time frame: One day following TKA surgery.]
- Morphological Differences of Cartilage and Subchondral [Time frame: One month following TKA surgery.]
- Subchondral Bone Osteoclast Activity [Time frame: One month following TKA surgery.]
- Subchondral Bone Osteoblastic Activity [Time frame: One month following TKA surgery.]
Eligibility criteria
Inclusion criteria
- 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.
- Voluntarily signs informed consent.
Exclusion criteria
- 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.
- Contraindications to MRI.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06977282 · SPHFJP-S2025079-1