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.
Avascular necrosis of the femoral head progresses rapidly, and most patients experience femoral head collapse within 1 to 4 years. Therefore, early intervention in the early stage of avascular necrosis of the femoral head is crucial for preserving the femoral head. Currently, core decompression is commonly used in clinical practice for early avascular necrosis of the femoral head. The principle is to drill holes and partially remove the necrotic lesions to reduce the pressure within the femoral head, increase blood supply, stimulate bone regeneration, thereby alleviating pain and delaying or reversing the progression of avascular necrosis of the femoral head. After the necrotic area of the femoral head is removed, bone grafting is often required to prevent complications such as femoral neck instability, femoral neck fractures, and femoral head collapse. There are many types of bone grafts, such as autologous bone, allogeneic bone, and artificial bone. However, autologous bone causes damage to the donor site and provides limited bone tissue; allogeneic bone has limited bone repair ability due to the lack of biological activity. Tissue engineering technology uses tissue engineering methods to transplant a composite of seed cells, growth factors, and scaffold materials to the bone defect site, providing good structural support and promoting bone tissue regeneration, thereby repairing the necrotic area of the bone and blood vessels. It has the advantages of no rejection reaction, unrestricted material acquisition, sufficient bone mass for cultivation, and easy survival, providing a new direction for the treatment of avascular necrosis of the femoral head. This study aims to evaluate the clinical effect of tissue-engineered bone in repairing early non-traumatic aseptic necrosis of the femoral head and provide a basis for the treatment of aseptic necrosis of the femoral head.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Tissue-engineered bone with autologous bone marrow mesenchymal stem cells
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, China
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.
Time frame: 1 month, 2 months, 3 months, 6 months and one year after the operation
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.
Time frame: Before the operation, 1 month, 6 months and 1 year after the operation
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).
Time frame: Before the operation, 6 months after the operation and 1 year after the operation
Verify the safety of tissue-engineered bone
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Number of participants with adverse events/serious adverse events, with abnormal laboratory tests results, abnormal vital signs, abnormal physical examination and abnormal electrocardiogram readings
Time frame: 1 month, 2 months, 3 months, 6 months and one year after the operation