Ibial fractures in children
Conditions
Interventions
Experimental group:receiving standard postoperative medical treatment + taking Bai Nian He Hu Vinegar Calcium Absorb
Control group:only received standard postoperative medical treatment
Sponsors
Children's Hospital Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
6 Years to 14 Years
Inclusion criteria
Inclusion criteria: (1) At the time of enrollment, the age should be no less than 6 years old and no more than 14 years old, with no gender restrictions. (2) Diagnosed by imaging as acute traumatic unilateral fracture of the lower extremity shaft or metaphysis (femur or tibia and fibula). (3) Has undergone surgical treatment (closed or open reduction and internal fixation) and the time has not exceeded 2 weeks. (4) During the study period, the child patient did not receive calcium supplementation preparations other than those in this study product. (5) The legal guardian of the child patient understands the purpose of the research, the possible risks and benefits of the research, voluntarily participates and signs a written informed consent form Children aged 8 and above need to sign the informed consent form for minors aged 8 and above. Children aged 6 to 8 should sign the informed consent form for minors under 8 years old. (6) Be able to comply with the research plan and be willing to complete all visits.
Exclusion criteria
Exclusion criteria: (1) Suffering from unstable or uncontrollable diseases, including but not limited to: central nervous system, cardiovascular and respiratory system, gastrointestinal tract, endocrine, hematological system, autoimmune or immunodeficiency diseases, metabolic bone diseases (such as osteogenesis imdefect, renal bone disease, parathyroid dysfunction, rickets, etc.), malignant tumors, etc. (2) Height < P3 (the third percentile). (3) Patients with pathological fractures or those with severe multiple fractures. (4) Known to be allergic to any of the ingredients in the research product. (5) Long-term use of glucocorticoids, antiepileptic drugs or other drugs that affect bone metabolism within the past three months. (6) Those who have participated in other clinical trials within 3 months prior to enrollment. (7) Fractures caused by low-energy injury (excluding fractures caused by osteoporosis itself). (8) Children who were diagnosed with osteoporosis (Z value = -2.0) by DXA examination upon admission. (9) The researcher believes that the subjects are not suitable for participating in the study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of osteoporosis in children with lower extremity fractures after systemic surgery;The incidence of symptomatic secondary fractures; | — |
Secondary
| Measure | Time frame |
|---|---|
| Height Velocit;Changes in bone density; | — |
Countries
China
Contacts
Public ContactHaibing Li
Children's Hospital Zhejiang University School of Medicine
Outcome results
None listed