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

NCT06977282 | Not Yet Recruiting

• 1 other identifier: SPHFJP-S2025079-1
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Participants were tested immediately after being included in the study.

Secondary Outcomes (16)

• Visual Analog Scale (VAS) score

  Participants were tested immediately after being included in the study.

• Pattern Element Analysis

  Participants were tested immediately after being included in the study.

• Function of Knee Joint

  Participants were tested immediately after being included in the study.

• Volume of Subchondral Cystic Lesions

  Participants were tested immediately after being included in the study.

• Brain Region Structure

  Participants were tested immediately after being included in the study.

Study Arms (2)

KOA

Patients with knee osteoarthritis of renal deficiency type who meet the diagnostic criteria

HC

Healthy volunteers

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinchao Xu: lead

Biospecimen

Retention: SAMPLES WITH DNA

Tibial plateau samples obtained from KOA patients during total knee arthroplasty.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: April 12, 2025
• First Posted: May 18, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-04