NCT07796607

Brief Summary

Before you are included in this study, you will undergo the following examinations to determine if you are eligible to participate: Before you are included in this study, your doctor will ask and record your medical history, conduct a physical examination on you, and perform necessary imaging tests. 2. If you are more than qualified examination, will study according to the following steps: if you meet the inclusion criteria, will study according to the following steps: (1) when you accept total knee replacement, the doctor will collect a small piece of articular cartilage (0.5 cm x 0.5 cm x 0.5 cm) used for research and analysis. (2) The process of collecting tissue specimens will be carried out by experienced orthopedic doctors, and the entire process will take approximately 5 to 10 minutes. One week and two weeks after the operation, the doctor will follow up with you to understand your recovery progress. 3, other matters need your cooperation: please timely follow-up to the hospital after the operation, so that the doctor evaluate your recovery.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

January 29, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2026

Completed
Last Updated

September 1, 2026

Status Verified

August 1, 2026

Enrollment Period

7 months

First QC Date

April 18, 2026

Last Update Submit

August 28, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Cell Morphology Assessed by Transmission Electron Microscopy

    Qualitative assessment of overall cell morphology (e.g., normal, swollen, necrotic) in articular cartilage samples.

    Perioperative/Periprocedural

  • Mitochondrial Status Assessed by Transmission Electron Microscopy

    Assessment of mitochondrial ultrastructure, including membrane integrity and cristae architecture.

    Perioperative/Periprocedural

  • Autophagosome Quantity Assessed by Transmission Electron Microscopy

    Quantification of autophagosome numbers per cell in articular cartilage samples.

    Perioperative/Periprocedural

Study Arms (2)

normal control

Osteoarthritis

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study enrolled 15 OA patients and 15 normal controls at Kunming Hospital of Traditional Chinese Medicine. All provided informed consent; basic and disease data were collected. Cartilage specimens were obtained intraoperatively by orthopedic surgeons. OA group: total knee arthroplasty patients. Normal control group: OA-free subjects from two sources: (1) femoral head replacement (Garden I/II) or knee arthroscopy for meniscal/ligament injury, and (2) traumatic lower-limb amputation. In source 1, cartilage was taken from the operated joint (hip/knee); in source 2, from the intact joint of the amputated limb. All control cartilage was confirmed Outerbridge grade 0 intraoperatively.

You may qualify if:

  • Osteoarthritis group:
  • Meets the American College of Rheumatology (ACR) diagnostic criteria for osteoarthritis: ① Persistent knee pain for ≥1 month; ② X-ray shows osteophytes at the knee joint margin; ③ Age ≥50 years; ④ Morning stiffness \<30 minutes; ⑤ Knee joint friction sounds. (Diagnosis requires item ① plus any two of items ②-⑤).
  • Radiographic Kellgren-Lawrence (K-L) grade ≥2;
  • Complete the entire treatment course without interruption or modification of the treatment plan during the process;
  • Complete the full-process assessment and follow-up;
  • The image and medical record materials are complete.
  • Normal control group:
  • Normal Control Group (subjects must meet criteria for one of the following two sources):
  • (1) Source A - Non-arthritic surgery patients:
  • )No history of knee osteoarthritis, rheumatoid arthritis, gouty arthritis, infectious arthritis, or other joint diseases 2)Undergoing surgery for one of the following indications:
  • Femoral neck fracture (Garden type I/II) treated with artificial femoral head replacement
  • Simple meniscus injury or ligament injury requiring knee arthroscopy 3)Preoperative X-ray of the joint from which cartilage will be collected shows normal joint space, K-L grade 0, and no osteophytes, subchondral sclerosis, or cystic change (hip joint for femoral head replacement; knee joint for arthroscopy) 3)Intraoperative macroscopic observation or specimen evaluation confirms smooth cartilage surface with no softening, fissure, or fibrosis (Outerbridge grade 0) 4)Complete imaging and medical records available
  • Source B - Traumatic amputees:
  • No history of any joint disease (knee osteoarthritis, rheumatoid arthritis, gouty, infectious arthritis, etc.)
  • Undergoing amputation of a lower limb purely for traumatic reasons, with no pre-existing joint pathology in the limb to be amputated
  • +3 more criteria

You may not qualify if:

  • ① Combined with other types of joint diseases, autoimmune diseases or bone metabolic diseases;
  • ② Has a history of drug abuse;
  • ③ Those who have not signed the informed consent form;
  • ④ Suffering from mental illness and unable to cooperate with research;
  • ⑤ Other personnel who are not suitable to participate in the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yunnan University of Chinese Medicine

Kunming, Yunnan, 650500, China

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sponsor

Study Record Dates

First Submitted

April 18, 2026

First Posted

September 1, 2026

Study Start

January 29, 2026

Primary Completion

August 31, 2026

Study Completion

August 31, 2026

Last Updated

September 1, 2026

Record last verified: 2026-08

Locations