Skip to content

A Study on the Application of Tongluo Yishen Formula in Post-Decompression Bone Grafting Surgery for Avascular Necrosis of the Femoral Head Based on Osteogenic Strength Evaluation

A Study on the Application of Tongluo Yishen Formula in Post-Decompression Bone Grafting Surgery for Avascular Necrosis of the Femoral Head Based on Osteogenic Strength Evaluation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001040
Enrollment
Unknown
Registered
2026-04-22
Start date
2026-03-03
Completion date
Unknown
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrosis of the femoral head

Interventions

Experimental Group:Tongluo Yisui Fang
Control Group:Calcium Carbonate D3 + Alendronate Sodium Tablets

Sponsors

China Academy of Traditional Chinese Medicine Wangjing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Meets the diagnostic criteria for adult ONFH as specified in the "Chinese Clinical Guidelines for the Diagnosis and Treatment of Adult Avascular Necrosis of the Femoral Head (2020)." (2) Patients with ONFH whose staging conforms to the 2019 International Bone Circulation Research Association (Association Research Circulation Osseous, ARCO) staging criteria for stages 1, 2, and 3A. (3) Underwent decompression and bone grafting surgery at our hospital, with stable postoperative condition. (4) Age between 18 and 80 years. (5) Voluntarily participates in the study, signs the informed consent form, and cooperates with data collection. (6) Able to adhere to the intake of Chinese herbal medicine and corresponding drug therapy.

Exclusion criteria

Exclusion criteria: (1) Patients with hip pain caused by developmental dysplasia of the acetabulum, hip osteoarthritis, ankylosing spondylitis, rheumatoid arthritis, femoroacetabular impingement syndrome, etc. (2) Patients who need to continue using hormones or have a history of alcohol abuse during treatment due to other illnesses. (3) Patients with severe hematological diseases, cerebrocardiovascular diseases, mental disorders, etc., who are unable to cooperate to complete case observation. (4) Patients receiving other treatment methods that may affect recovery and regular assessment. (5) Patients allergic to Chinese medicine and its components, or those who experience gastrointestinal discomfort, and are unable to take medication regularly. (6) Patients unable to take alendronate sodium due to conditions such as gastroesophageal reflux disease.

Design outcomes

Primary

MeasureTime frame
Imaging indicators (X-ray necrotic area ratio);

Secondary

MeasureTime frame
Visual Analog Scale (VAS pain score);Harris Hip Score (Harris Score);Imaging indicators (bone density values);Biochemical Index Testing (Bone Metabolism Marker Testing);Biochemical Index Testing (Biochemical Protein Testing);

Countries

China

Contacts

Public ContactQin Wei Kai

China Academy of Traditional Chinese Medicine Wangjing Hospital

qinvkai@163.com15810505530

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026