About this trial
The commercial decalcified bone scaffold combined with the patient's autologous bone marrow mesenchymal stem cells was used for in vitro culture to form tissue-engineered bone, and the effect of this tissue-engineered bone in early non-traumatic femoral head necrosis was explored.
Eligibility criteria
Qualifiers
Capable of understanding and voluntarily signing the informed consent form before the study;
Meets the diagnostic criteria in the "Clinical Diagnosis and Treatment Guidelines for Adult Femoral Head Necrosis in China (2020)";
Age range: 20 - 65 years old (inclusive of boundary values), gender not restricted;
Staged as ARCO II stage;
Disqualifiers
Based on the researcher's judgment, the subjects had a history of trauma and the injury affected the target hip joint;
In the six months prior to screening, there were obvious injuries involving the target hip joint;
The subject's femoral head necrosis was due to other diseases affecting the hip joint (such as rheumatoid arthritis, psoriatic arthritis, gouty arthritis, symptomatic cartilage calcification, bone necrosis, active infection), or according to the researcher's judgment, peripheral or central nervous system lesions that might affect the assessment of pain and function of the target hip joint (such as back pain, knee joint disease, intervertebral disc protrusion, sciatic nerve pain, fibromyalgia, diabetic neuropathy, etc.);
The femoral head of the target hip joint had obvious necrosis, collapse, joint fusion, etc.;
Trial design
Treatments tested in this trial
- Tissue-engineered bone