Study of bone cell changes in steroid-related femoral head necrosis using discarded tissue from routine hip replacement surgery

ISRCTN	ISRCTN72490358
DOI	https://doi.org/10.1186/ISRCTN72490358
Sponsor	Luoyang Orthopedic-Traumatological Hospital of Henan Province
Funder	State Administration of Traditional Chinese Medicine of the People's Republic of China

Submission date: 24/02/2026
Registration date: 03/03/2026
Last edited: 25/02/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Xiaoxia Yan
Scientific, Principal investigator, Public

Henan Province
Zhengzhou City
450000
China

ORCID ID	0009-0002-4763-4476
Phone	+86 (0)18736095609
Email	641594851@qq.com

Study information

Primary study design	Observational
Observational study design	Case-control study
Scientific title	Case-control study of osteoblastic mitochondrial quality control disorder in glucocorticoid-induced osteonecrosis of the femoral head
Study acronym	MQC-GONFH-PP
Study objectives
Ethics approval(s)	Approved 04/02/2026, Ethics Committee of Luoyang Orthopedic-Traumatological Hospital of Henan Province (Henan Provincial Orthopedic Hospital) (Henan Province, Luoyang City, 471200, China; +86 (0)15837982681; hnslyzgyyllwyh@aliyun.com), ref: 2026KYKT0001-01
Health condition(s) or problem(s) studied	Glucocorticoid-induced osteonecrosis of femoral head
Intervention	This is a non-interventional case-control study with a 1:1 matching design. The case group consists of patients diagnosed with glucocorticoid-induced osteonecrosis of femoral head (GONFH) who require total hip arthroplasty, and the control group consists of patients with femoral neck fracture who require total hip arthroplasty and are matched with the case group by age (±5 years) and the same gender. No additional interventions are provided except routine clinical treatment for all participants. During the study, relevant samples are collected after total hip arthroplasty, and tests including Western Blot, qRT-PCR, transmission electron microscopy (TEM), immunohistochemistry (IHC), HE staining and Masson staining are performed to detect the expression levels of key molecules in the PINK1/Parkin signaling pathway, mitochondrial morphology and cristae structure, and the degree of osteoblast mitochondrial quality control disorder. Statistical analysis is used to explore the correlation between mitochondrial quality control disorder and GONFH Ficat stage.
Intervention type	Other
Primary outcome measure(s)	Expression levels of key molecules in PINK1/Parkin signaling pathway (PINK1, Parkin and Drp1) measured using Western Blot and qRT-PCR at the end of sample collection, which is after total hip arthroplasty of the participants
Key secondary outcome measure(s)
Completion date	31/12/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	70 Years
Sex	All
Target sample size at registration	12
Key inclusion criteria	1. Patients diagnosed with glucocorticoid-induced osteonecrosis of femoral head (GONFH) or femoral neck fracture, who need total hip arthroplasty 2. Aged 18-70 years old 3. Femoral neck fracture patients are matched 1:1 with GONFH patients by age (±5 years) and same gender 4. The interval between injury and total hip arthroplasty is less than 3 weeks for femoral neck fracture patients 5. GONFH patients meet Ficat stage II-IV 6. Voluntarily participate and sign the informed consent form
Key exclusion criteria	1. Complicated with other metabolic bone diseases, such as severe osteoporosis, hyperparathyroidism 2. Complicated with other diseases that may cause abnormal bone metabolism, such as severe diabetes, gout 3. Complicated with malignant tumors
Date of first enrolment	01/03/2026
Date of final enrolment	31/10/2026

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

25/02/2026: Study's existence confirmed by the Ethics Committee of Luoyang Orthopedic-Traumatological Hospital of Henan Province (Henan Provincial Orthopedic Hospital).