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.
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;
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.;
Single group
Tissue-engineered bone
DeviceTissue-engineered bone with autologous bone marrow mesenchymal stem cells
To verify the effectiveness of tissue-engineered bone in the treatment of early femoral head necrosis
The judgment is mainly based on the X-ray plain films and MRI results of the hip joint during the follow-up process: ① Improvement: New bone is generated in the necrotic bone tissue within the femoral head; ② Unchanged: There was no further collapse of the femoral head; ③ Deterioration: Femoral head collapses, osteoarthritis occurs in the femoral head, and total hip replacement arthroplasty (THA) is performed. If the imaging indicates improvement or no change, the imaging is successful; if it indicates deterioration, it is a failure.
To verify the effectiveness of tissue-engineered bone in the treatment of early femoral head necrosis
The degree of pain of the patients was evaluated by visual analogue scales (VAS) before the operation, 1 month, 6 months and 1 year after the operation respectively. The VAS pain score standard: A score of 0 to 10, from low to high, indicates an increase in the degree of pain. A score of 0 indicates no pain, and a score of 10 indicates severe and unbearable pain.
To verify the effectiveness of tissue-engineered bone in the treatment of early femoral head necrosis
The hip joint function of the patients was evaluated by Harris score before the operation, 6 months after the operation and 1 year after the operation respectively. The total score of the Harris score is 100 points, including 44 points for the pain score, 51 points for the functional score (daily activities, walking gait, walking distance, degree of deformity), and 5 points for the range of motion of the hip joint (forward flexion, abduction, external rotation, adduction, internal rotation).
Verify the safety of tissue-engineered bone
Number of participants with adverse events/serious adverse events, with abnormal laboratory tests results, abnormal vital signs, abnormal physical examination and abnormal electrocardiogram readings
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