Non-traumatic osteonecrosis of the Femoral Head
Conditions
Interventions
Intervention Group :Oral administration of Gushi Shengmai decoction
Control Group:Oral administration of Alendronate Sodium Tablets (Fosamax)
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine Shanghai
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Age =18 years and =70 years regardless of gender. (2) Meet the clinical diagnostic criteria for non-traumatic osteonecrosis of the femoral head and be classified as ARCO stage I or II. (3) Meet the diagnostic criteria for Qi stagnation and blood stasis syndrome according to Traditional Chinese Medicine (TCM) theory. (4) Be able to understand and sign the informed consent form for this study.
Exclusion criteria
Exclusion criteria: (1) Osteonecrosis of the femoral head occurring in a hip joint following trauma. (2) Diagnosis complicated by non-osteonecrotic metabolic bone diseases such as Paget's disease osteogenesis imperfecta primary hyperparathyroidism fibrous dysplasia of bone and osteopetrosis. (3) Previous history of hip replacement surgery or concurrent hip joint diseases lower limb neuropathy or collapse-related lesions. (4) Presence of other bone and joint diseases such as septic arthritis ankylosing spondylitis rheumatoid arthritis Kashin-Beck disease pigmented villonodular synovitis or hip joint tuberculosis. (5) Allergy to the study drug or contraindications related to the study drug including hypocalcemia (serum calcium <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 esophageal emptying (e.g. esophageal stricture or achalasia). (6) Contraindications to magnetic resonance imaging (MRI) such as the presence of MRI-incompatible internal devices (e.g. pacemakers aneurysm clips). (7) Participation in or completion of other clinical trials within 3 months prior to enrollment. (8) Pregnancy lactation or planning for pregnancy. (9) Presence of diseases that in the investigator's opinion may hinder the participant's ability to complete the trial such as stress fractures coagulation disorders history of malignant diseases critical illness history of sepsis HIV infection chronic liver failure positive hepatitis serology chronic renal failure (creatinine clearance <35.0 mL/min) severe cardiac diseases (e.g. atrial fibrillation) or psychiatric disorders. (10) Active treatment for cancer or hematological malignancies or receipt of chemotherapy radiotherapy or immunotherapy within the past 2 years or use of anticoagulants immunosuppressants cytotoxic drugs or other medications that cannot be discontinued during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hip Harris Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hip Flexion Function Score;TCM Syndrome Score Evaluation;Femoral Head Morphology Score;Walking Distance Score;Clinical Response Rate;Radiological Evaluation;Necrotic Area Score;Osteoarthritis Score;Serum Bone Metabolism;Visual Analog Scale (VAS) Pain Score;Clinical Evaluation of Therapeutic Efficacy in Traditional Chinese Medicine (TCM); | — |
Countries
China
Contacts
Public ContactLi Bo
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine Shanghai China
Outcome results
None listed