Aseptic loosening of artificial joint
Conditions
Interventions
Normal bone mass group 1 versus Normal bone mass group 2:Normal bone mass group 1 giving calcium carbonate D3 tablets (600 mg/day, oral), and alendronate sodium D3 tablets (1 tablet/week, oral) for 2
Osteoporosis group 1 versus Osteoporosis group 2:Osteoporosis group 1 giving Zoledronic acid: calcium carbonate D3 tablets (600 mg / day, oral), calcitriol capsules (0.25 ug / day, oral), zoledronic a
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part I - the prevention and treatment of bisphosphonates on the aseptic loosening of the prosthesis after total hip arthroplasty in patients with normal bone mass Inclusion criteria 1. Age 30-70 years old; 2. The proximal femoral morphological classification of Dorr A or B; 3. Non-cemented primary unilateral total hip arthroplasty for hip osteoarthritis, avascular necrosis of the femoral head and developmental dislocation of the hip; 4. The T value of lumbar vertebrae, hip and femoral neck measured by DEXA is not lower than -1, and the bone mass is normal. 5. The patient's physical condition can tolerate surgery; 6. Patients and their families understand the clinical trial and sign an informed consent form. Part II - Effect of bisphosphonates on aseptic loosening of prosthesis after total hip arthroplasty in patients with osteoporosis Inclusion criteria 1. Age 55-80 years old; 2. The proximal femoral morphological classification of Dorr A or B; 3. Non-cemented primary unilateral total hip arthroplasty for femoral neck fracture, hip osteoarthritis, avascular necrosis of the femoral head and developmental dislocation of the hip; 4. DEXA measured the T value of any part of the lumbar vertebrae, hip and femoral neck less than -2.5 or had a fragility fracture, diagnosed as osteoporosis; 5. The patient's physical condition can tolerate surgery; 6. Patients and their families understand the clinical trial and sign an informed consent form.
Exclusion criteria
Exclusion criteria: Part I - the prevention and treatment of bisphosphonates on the aseptic loosening of the prosthesis after total hip arthroplasty in patients with normal bone mass: 1. Malnutrition (MNA-SF score = 11); 2. Combine diseases that cause abnormal bone metabolism; 3. History of previous affected hip surgery; 4. Combine drugs that have an effect on bone metabolism; 5. Allergic to experimental drugs; 6. Severe heart and lung, liver and kidney failure, malignant tumor; 7. Combine diseases that affect bone density around the joint, such as rheumatoid arthritis, ankylosing spondylitis, etc. Part II - Effect of bisphosphonates on aseptic loosening of prosthesis after total hip arthroplasty in patients with osteoporosis: 1. Malnutrition (MNA-SF score = 11); 2. Diagnosis of secondary osteoporosis or a combination of diseases leading to abnormal bone metabolism; 3. History of previous affected hip surgery; 4. Drugs that have an effect on bone metabolism; 5. Allergic to experimental drugs; 6. Severe heart and lung, liver and kidney failure, malignant tumor; 7. Combine diseases that affect bone density around the joint, such as rheumatoid arthritis, ankylosing spondylitis, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of aseptic loosening of artificial joints;Bone mineral density in the Gruen 1 area-7 area around the prosthesis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Imaging indicators of artificial joint prosthesis loosening: acetabular anteversion, abduction angle, femoral sinking value, horizontal distance and vertical distance of acetabulum;Harris score;Quality of Life Score (EQ-5D);Bone turnover index (ß-CTX, PINP) and blood calcium, VitD levels;Lumbar spine and hip bone density;Adverse reactions in patients; | — |
Countries
China
Contacts
Public ContactYue Ding
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed