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The clinical diagnosis and treatment of lower limb bone defect is a difficult problem in orthopedics. The traditional treatment has the shortcomings of long treatment period, no weight bearing in the early stage of the limb, weak mechanical strength, many complications, and difficulty in repairing deformed and large segment bone defects around the joint. The Orthopedics Department of Peking University Third Hospital, the lead unit of this study, developed the TCBridge system based on three-dimensional (3D) printing technology in the early stage, which is the first approved 3D printing lower limb long bone defect repair system in China. The system can achieve personalized and accurate repair of lower limb bone defects, and ensure patients to carry out limb weight and functional exercise safely in the early stage after surgery. On this basis, this study will establish a multi-center clinical case cohort to achieve accurate comprehensive diagnosis and treatment of lower limb bone defects, benefiting patients and contributing to society.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traumatic bone defect in lower limb | Traumatic bone defect in lower limb |
| |
| Infective lower limb bone defect | Infective lower limb bone defect |
| |
| Neoplastic bone defect in lower limb | Neoplastic bone defect in lower limb |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D printed prostheses | Device | 3D printed prostheses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of implant stability, new bone growth- limb length | X-ray XćCT images | post-operative 1.3.6.12.24.36 months |
| Evaluation of bone healing | computed tomography (CT) | post-operative 3.6.12.24.36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain assessment | Visual Analog Score (VAS), total score is 10, "0" represents no pain, "10" represents the most unbearable pain | post-operative 1.3.6.12.24.36 months |
| Evaluation of life quality and health status. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with lower limb defects
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bingchuan Liu, Doctor | Contact | +86 18310188678 | liubc@bjmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | Haidian | China |
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36-item short form survery (SF-36) questionnaire, it includes 8 itmem, namely physical functioning, vitality, bodily pain, general health, social functioning, role physical, role emotional, mental health. The maximum score of each item is 100, higher score represents better result.
| post-operative 1.3.6.12.24.36 months |
| Evaluation of knee function | hospital for special surgery (HSS) score. The maximum score of HSS is 100, higher score represents better result. | post-operative 1.3.6.12.24.36 months |
| Evaluation of hip function | Harris score, The maximum score of Harris score is 100, higher score represents better result. | post-operative 1.3.6.12.24.36 months |
| Evaluation of ankle function | American Orthopaedic Foot & Ankle Society (AOFAS) scoreļ¼The maximum score of AOFAS score is 100, higher score represents better result. | post-operative 1.3.6.12.24.36 months |