Clinical trial NCT06977282: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Osteoarthitis
Lead sponsor: Fujian University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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: 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.

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
timeFrame: Participants were tested immediately after being included in the study.
Secondary outcomes:
measure: Visual Analog Scale (VAS) score
timeFrame: Participants were tested immediately after being included in the study.
measure: Pattern Element Analysis
timeFrame: Participants were tested immediately after being included in the study.
measure: Function of Knee Joint
timeFrame: Participants were tested immediately after being included in the study.
measure: Volume of Subchondral Cystic Lesions
timeFrame: Participants were tested immediately after being included in the study.
measure: Brain Region Structure
timeFrame: Participants were tested immediately after being included in the study.
measure: Brain Region Functional Connection
timeFrame: Participants were tested immediately after being included in the study.
measure: Serum Neurotransmitters
timeFrame: Participants were tested immediately after being included in the study.
measure: Serum Inflammatory Cytokines
timeFrame: Participants were tested immediately after being included in the study.
measure: Microarchitecture of Subchondral Bone
timeFrame: One day following TKA surgery.
measure: Morphological Differences of Cartilage and Subchondral
timeFrame: One month following TKA surgery.
measure: Subchondral Bone Osteoclast Activity
timeFrame: One month following TKA surgery.
measure: Subchondral Bone Osteoblastic Activity
timeFrame: One month following TKA surgery.
measure: Subchondral Bone Sensory Nerve Fiber Distribution
timeFrame: One month following TKA surgery.
measure: Pain-Sensitization-Related Factors in Subchondral Bone
timeFrame: One month following TKA surgery.
measure: Subchondral Bone Osteoclast Marker
timeFrame: One month following TKA surgery.
measure: Subchondral Bone Nociceptor Distribution
timeFrame: One month following TKA surgery.
Other outcomes:
Locations:
Study officials:
References: