Non-traumatic femoral head necrosis
Conditions
Interventions
Control Group:Alendronate Sodium Tablets Oral
Experimental Group:Osteoclast Pulse Generating Formula Oral
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 years or older and 70 years or younger; gender is not restricted; (2) Meets the clinical criteria for non-traumatic avascular necrosis of the femoral head and is classified as ARCO Stage I or II; (3) Meets the Traditional Chinese Medicine (TCM) pattern of diagnosis of 'qi stagnation and blood stasis'; (4) Willing to participate in this trial and able to adhere to the treatment plan specified in the protocol; (5) Able to understand and sign the informed consent form for this study.
Exclusion criteria
Exclusion criteria: (1) Atraumatic avascular necrosis of the femoral head occurring after trauma to the hip joint; (2) Diagnosis of non-osteonecrotic metabolic bone diseases, such as Paget's disease of bone, osteogenesis imperfecta, primary hyperparathyroidism, fibrous dysplasia of bone, and osteopetrosis; (3) Previous hip arthroplasty or concurrent other hip diseases, lower extremity neuropathy, or collapse-related lesions; (4) Other bone and joint diseases, such as pyogenic arthritis, ankylosing spondylitis, rheumatoid arthritis, Kashin-Beck disease, pigmented villonodular synovitis, or tuberculous arthritis of the hip; (5) Allergy to the study drug or presence of contraindications related to the study drug: hypocalcemia (serum calcium below 8 mg/dL or 2.0 mmol/L), urticaria, angioedema, inability to stand or sit for at least 30 minutes, or esophageal abnormalities causing delayed emptying (e.g., esophageal stenosis or achalasia); (6) Presence of contraindications for magnetic resonance imaging (MRI), such as implanted devices incompatible with MRI (e.g., pacemakers, aneurysm clips); (7) Participation in other clinical trials within the past 3 months or currently participating; (8) Pregnancy, lactation, or planning to become pregnant; (9) Suffering from conditions deemed by the investigator to hinder the participant's ability to complete the trial, such as stress fractures, coagulation disorders, history of malignancy, critically ill patients, history of sepsis, HIV infection, chronic liver failure, positive hepatitis serology, chronic kidney failure (creatinine clearance below 35.0 mL/min), severe heart disease (e.g., atrial fibrillation), or psychiatric disorders; (10) Currently undergoing active cancer treatment or cachexia, or having received chemotherapy, radiotherapy, or immunotherapy for cancer within the past 2 years, or using anticoagulants, immunosuppressants, or cytotoxic drugs that cannot be discontinued during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood flow volume; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time-averaged blood flow velocity;Resistance index;Harris score;visual analogue scale;Hip Flexion Functional Assessment Score;Walking Distance Rating;Traditional Chinese Medicine Syndrome Scoring Evaluation;Prothrombin Time;Activated Partial Thromboplastin Time;Thrombin Time;Fibrinogen; | — |
Countries
China
Contacts
Public ContactLi Bo
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed