Osteoarthritis (OA)NCT07796607
Research on the Pathogenesis and Therapeutic Targets of Articular Cartilage Degeneration in Osteoarthritis
An observational study of Osteoarthritis (OA), run by Yunnan University of Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis (OA)
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 29 Jan 2026to 31 Aug 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
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- Normal control group:
- Normal Control Group (subjects must meet criteria for one of the following two sources):
- Source A - Non-arthritic surgery patients:
- 1)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
- Preoperative X-ray of the target joint (typically knee or hip) shows K-L grade 0 and no signs of osteoarthritis
- Intraoperative macroscopic evaluation of the articular cartilage from the amputated limb confirms Outerbridge grade 0 (smooth, intact surface)
- Complete imaging and medical records available Both sources: Signed informed consent for voluntary participation
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Osteoarthritis (OA)
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| normal control | Not described | |
| Osteoarthritis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell Morphology Assessed by Transmission Electron Microscopy
Qualitative assessment of overall cell morphology (e.g., normal, swollen, necrotic) in articular cartilage samples.
Measured: Perioperative/Periprocedural
Mitochondrial Status Assessed by Transmission Electron Microscopy
Assessment of mitochondrial ultrastructure, including membrane integrity and cristae architecture.
Measured: Perioperative/Periprocedural
Autophagosome Quantity Assessed by Transmission Electron Microscopy
Quantification of autophagosome numbers per cell in articular cartilage samples.
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start29 Jan 2026
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Yunnan University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaofu Li, Yunnan University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796607
- Sponsor's protocol ID
- XS2023-019
- Status last verified
- Aug 2026
- First submitted
- 18 Apr 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Pathogenesis and Therapeutic Targets of Articular Cartilage Degeneration in Osteoarthritis
- ClinicalTrials.gov ID
- NCT07796607
- Acronym / sponsor ID
- XS2023-019
- Conditions
- Osteoarthritis (OA)
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yunnan University of Chinese MedicineUniversity, hospital or other
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal control | – | – |
| Osteoarthritis | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cell Morphology Assessed by Transmission Electron Microscopy
Time frame: Perioperative/Periprocedural
Qualitative assessment of overall cell morphology (e.g., normal, swollen, necrotic) in articular cartilage samples.
Mitochondrial Status Assessed by Transmission Electron Microscopy
Time frame: Perioperative/Periprocedural
Assessment of mitochondrial ultrastructure, including membrane integrity and cristae architecture.
Autophagosome Quantity Assessed by Transmission Electron Microscopy
Time frame: Perioperative/Periprocedural
Quantification of autophagosome numbers per cell in articular cartilage samples.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis (OA), run by Yunnan University of Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cell Morphology Assessed by Transmission Electron Microscopy (time frame: Perioperative/Periprocedural). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.