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The purpose of this study is to compare use of a tissue-engineered bone to use of a standard allograft bone to treat bone defect in patients. The hypothesis is that use of the tissue-engineered bone is effective and safe to treat the bone defect in patients.
Patients with the bone defect without infection and sever system diseases will be recruited.
The material selected as the scaffold for this study will be a porous β-tricalcium phosphate scaffold (β-TCP) scaffold and scaffold is custom-made according to the size and shape of bone defect after three-dimensional CT scan. Human BMSCs will be obtained and cultured before operation and 3.4×106 cells in 10ml serum-free medium will be seeded onto scaffold to construct the tissue engineered bone graft and co-cultured for two weeks.
The implant operation will be carried out under the general anesthesia. The tissue engineered bone graft will be implanted into the bone defect area. The bone defect area will be covered with surrounding soft tissue and muscle to close the wound. Anti-inflammatory, repercussive and analgesic drugs will be used for 1 week.
Patient will be hospitalized for 1 to 2 weeks after surgery. Blood routine examination, erythrocyte sedimentation rate, immunoglobulin, autoantibodies and clinical examination will be carried out for signs of pain, swelling, immune rejection and infection. Patient will be evaluated at 3 days，3, 6, 12, 18 and 22 months after operation by radiography; Three-dimensional CT scan will be also performed at regular intervals. The function of the body will be evaluated at regular intervals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| allograft bone | Active Comparator | traditional allograft bone |
|
| tissue-engineered bone | Experimental | tissue-engineered bone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| allograft bone | Device | Use of the allograft bone to treat the bone defect in patients |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The scores of bone healing | The scores of bone healing are divided into three kinds: nonhealing: 0; delayed healing: 1; normal healing: 2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone. | within 48 weeks after surgical treatment of bone dect |
| the adverse event incidence using tissue-engineered bone and allograft bone | the adverse event incidence of tissue-engineered bone is compared with the adverse event incidence of allograft bone to verify the safety of tissue-engineered bone. | within 24 weeks after surgical treatment of bone dect |
| Measure | Description | Time Frame |
|---|---|---|
| The scores of blood routine test | The scores of blood routine test after operation are divided into three kinds: severely abnormal：0；abnormal：1；normal：2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone. | within 48 weeks after surgical treatment of bone dect |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| long bi, MD,PHD | Contact | +86 02984773524 | bilong@fmmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopedics, Xijing Hospital, The Fourth Military Medical University | Recruiting | Xi’an | Shanxi | 710032 | China |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 28, 2024 | |
| Reset | Oct 3, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 28, 2024 | Oct 3, 2024 |
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| tissue-engineered bone |
| Device |
Use of the tissue-engineered bone to treat the bone defect in patients |
|
| The scores of erythrocyte sedimentation rate(ESR) | The scores of erythrocyte sedimentation rate (ESR) after operation are divided into three kinds: severely abnormal：0；abnormal：1；normal：2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone. | within 48 weeks after surgical treatment of bone dect |
| The scores of C-reactive protein | The scores of C-reaction protein after operation are divided into three kinds: severely abnormal：0；abnormal：1；normal：2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone. | within 48 weeks after surgical treatment of bone dect |
| The scores of the ratio of complement C3 to complement C4 | The scores of ratio of complement C3 to C4 after operation are divided into three kinds: severely abnormal：0；abnormal：1；normal：2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone. | within 48 weeks after surgical treatment of bone dect |
| The scores of immunoglobulin assay | The scores of immunoglobulin assay (IgG, IgA and IgM) after operation are divided into three kinds: severely abnormal：0；abnormal：1；normal：2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone. | within 48 weeks after surgical treatment of bone dect |
| The scores of duration of hospital stay | The scores of duration of hospital stay are divided into four kinds: longer than one months: 0; longer than two weeks:1; longer than one week:2; less than one week:3. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone. | within 48 weeks after surgical treatment of bone dect |
| the scores of time of weight loading after operation | The scores of time of weight loading after operation are divided into three kinds: longer than six months: 0; longer than three months:1; less than three months:2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone. | within 48 weeks after surgical treatment of bone dect |
| The scores of tumorigenesis | The scores of tumorigenesis after operation are divided into three kinds: severely abnormal：0；abnormal：1；normal：2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone. | within 48 weeks after surgical treatment of bone dect |
| The scores of treatment course | The scores of treatment course are divided into three kinds: long：0；general ：1；short：2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone. | within 48 weeks after surgical treatment of bone dect |
| The scores of number of operations | The scores of number of operations are divided into four kinds: above three times：0； three times：1；two times：2；one time：3. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone. | within 48 weeks after surgical treatment of bone dect |
| The scores of pain | The scores of pain after operation are divided into four kinds: severe:0;moderate:1;slight:2; none:3. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone. | within 48 weeks after surgical treatment of bone dect |
| The scores of wound healing of soft tissue | The scores of wound healing are divided into four kinds: infection: 0; no healing: 1; delayed healing: 2; normal healing: 3. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone. | within 48 weeks after surgical treatment of bone dect |