osteonecrosis of femoral head
Conditions
Interventions
experimental group:Degradable Magnesium Bone Fixation Screws
Control group:directly inserting vascularized bone grafts into necrotic sites
Sponsors
Zhongnan Hospital of Wuhan University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1 Aged between 18 and 55 years; 2 Suffer from unilateral osteonecrosis of femoral head and need vascularized bone graft transplant to cure. If suffer from bilateral osteonecrosis of femoral head and both sides need treatment, operation should be first performed on one side and then performed on the other side at least 3 months after confirming that the first operation will not influence this side. If both sides are treated at the same time, the side with poorer efficacy should be used for the analysis. 3 At phase II or III according to ARCO phase of osteonecrosis of femoral head. 4 Know exactly the study objectives, voluntarily sign informed consent and can complete the whole study process according to the requirements of the present protocol.
Exclusion criteria
Exclusion criteria: 1 Suffer from acute or severe infection. 2 Suffer from hypermagnesemia 3 Used corticosteroid in nearly three months 4 Suffer from serious cardiovascular disease, diabetes, blood coagulation dysfunction, mental and nervous system disease,or with osteoporosis, calcium-phosphorus metabolism disorder and some other medical history. 5 Drug abusers 6 In the acute-outbreak period of chronic disease. 7 Suffer from malignant disease and can survive for less than 12 months. 8 Liver dysfunction is 1.5 times beyond the normal range. 9 Patients with acute or chronic renal insufficiency (serum creatinine is 1.5 times higher than normal). 10 Have a history of severe allergic or are allergic to magnesium. 11 Pregnancy and nursing females. 12 Have poor compliance and cannot attend follow-up visits on schedule. 13 Participate in other clinical trials at the same time. 14 Other patients that investigators think unsuitable to participate in present investigation. 15 Patients taking medications that may affect magnesium metabolism, or disorders of the organs associated with magnesium metabolism, such as, but not limited to, renal dysfunction, adrenal dysfunction, thyroid and parathyroid dysfunction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of subjects without displacement of vascularized bone grafts 6 month after operation;Healing rate of vascularized bone grafts 6 month after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of operation;The rate of non-displacement of vascularized bone flap fixed with degradable magnesium bone internal fixation screw at 1 month after surgery was not less than 95%;Success rate of radiographic evaluation on transplantation sites at 3, 6 and 12 months after operation;Harris hip scores of subjects 6, 12 months after operation;Residual percentage of screw diameter for Degradable Magnesium Bone Internal Fixation Screws at 3, 6, and 12 months after operation;Operating performance of Mg screws during the operation;Femoral head collapse rate at 12 months after operation;Bone ingrowth at 12 months after operation; | — |
Countries
China
Contacts
Public ContactYu Aixi
Zhongnan Hospital of Wuhan University
Outcome results
None listed