Unravelling the cell subsets of osteonecrosis of the femoral head
| ISRCTN | ISRCTN86670828 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86670828 |
| Sponsor | Luoyang Orthopedic Hospital of Henan Province, Orthopedic Hospital of Henan Province |
| Funder | Administration of Traditional Chinese Medicine of Henan Province (Grant No. 2025ZY1023) |
- Submission date
- 06/02/2026
- Registration date
- 10/02/2026
- Last edited
- 09/02/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Osteonecrosis of the femoral head (ONFH) is a progressive, disabling disease that often occurs in young and middle-aged populations and severely affects patients' quality of life. However, heterogeneity of subchondral bone cell types present in ONFH is still unknown. Single cell RNA sequencing (scRNA‐seq) technology can show detailed examination of cellular and molecular diversity. The aim of this study is to identify all major cell populations and immune microenvironment interaction in patients with ONFH using scRNA-Seq.
Who can participate?
Adults aged between 20 and 65 years with ONFH undergoing THA surgery in our hospital
And control group: Patients with femoral neck fracture or hip osteoarthritis undergoing THA surgery in our hospital
What does the study involve?
This is a non-interventional, biological specimen research study. It involves the use of hip joint tissues that are routinely removed and discarded during standard total hip arthroplasty surgery from ONFH, OA or femoral neck fracture. The collected tissues will be processed in the laboratory for single-cell RNA sequencing, histological analysis, and/or molecular biology experiments to investigate disease mechanisms. No further contact or procedures with the participant are required. All tissue samples and data will be de-identified.
What are the possible benefits and risks of participating?
Participants will receive no direct medical benefit from this research, as the hip joint tissues are surgical discards and the research procedures are performed after the standard therapeutic surgery is complete.
Where is the study run from?
The study is conducted at Luoyang Orthopedic Hospital of Henan Province, Orthopedic Hospital of Henan Province, Luoyang, Henan, China.
When is the study starting and how long is it expected to run for?
January 2026 to October 2026
Who is funding the study?
Administration of Traditional Chinese Medicine of Henan Province (Grant No. 2025ZY1023) (China)
Who is the main contact?
Yage Luo, L03790371@163.com
Contact information
Public
No.82, Qiming South Road
Luoyang
471002
China
 ORCID ID |
0000-0002-2335-910X |
|---|---|
| Phone | +86 15038552124 |
| L03790371@163.com |
Scientific
No.82, Qiming South Road
Luoyang
471002
China
| ORCID ID |
0009-0000-8007-1359 |
|---|---|
| Phone | +86 15237950888 |
| DoctorGuoJY@outlook.com |
Principal investigator
No.82, Qiming South Road
Luoyang
471002
China
| ORCID ID |
0000-0003-4863-0864 |
|---|---|
| Phone | +86 13526976381 |
| 596681500@qq.com |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Descriptive observational study |
| Scientific title | Cellular dissection of the bone immune microenvironment in osteonecrosis of the femoral head |
| Study objectives | The aim of this study is to clarify the changes in the number and function of early immune cell subsets in patients with ONFH and the interaction between multiple different cell subsets at an overall level. |
| Ethics approval(s) |
Approved 14/10/2025, Ethics Committee of Luoyang Orthopedic Hospital of Henan Province (No. 82, Qiming South Road, Luoyang, 471002, China; +86 379-63546181; hnslyzgyyllywh@aliyun.com), ref: the Project of TCM research in Henan Province (Grant No.2025KYKT0039-01) |
| Health condition(s) or problem(s) studied | Patients with glucocorticoid-induced osteonecrosis of the femoral head |
| Intervention | This is a non-interventional, biological specimen research study. It involves the use of hip joint tissues that are routinely removed and discarded during standard total hip arthroplasty surgery from ONFH, OA or femoral neck fracture. The collected tissues will be processed in the laboratory for single-cell RNA sequencing, histological analysis, and/or molecular biology experiments to investigate disease mechanisms. No further contact or procedures with the participant are required. All tissue samples and data will be de-identified. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 20 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 15 |
| Key inclusion criteria | 1. Experimental group: Patients with femoral head necrosis undergoing THA surgery in our hospital 2. Control group: Patients with femoral neck fracture or hip osteoarthritis undergoing THA surgery in our hospital 3. Willingness to participate in the study and provision of signed informed consent. |
| Key exclusion criteria | 1. Patients with unclear diagnosis 2. Issues with sample quality:Biological samples with severe contamination or other problems during collection, transportation or preservation, which may affect the accuracy of experimental test results.Samples with insufficient quantity to meet the requirements of experimental detection, making them unsuitable for IHC assays. 3. Special populations and other conditions:Pregnant or lactating women. 4. Patients who have recently (within one month) used drugs that may affect experimental results. 5. Patients with severe systemic diseases such as heart, liver or kidney diseases, or those with mental illnesses, malignant tumors or other diseases that may affect research results or life expectancy. |
| Date of first enrolment | 23/01/2026 |
| Date of final enrolment | 31/05/2026 |
Locations
Countries of recruitment
- China
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
06/02/2026: Trial's existence confirmed by Ethics Committee of Luoyang Orthopedic Hospital of Henan Province.
