Peking University Third Hospital
Beijing, Haidian, China
Location status: Recruiting
NCT Number: NCT06269354
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.
Interested in participating?
Request Info18 year–90 year
All sexes
Observational
Beijing, Haidian, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3D printed prostheses
Time frame: post-operative 1.3.6.12.24.36 months
X-ray X、CT images
Time frame: post-operative 3.6.12.24.36 months
computed tomography (CT)
Time frame: post-operative 1.3.6.12.24.36 months
Visual Analog Score (VAS), total score is 10, "0" represents no pain, "10" represents the most unbearable pain
Time frame: post-operative 1.3.6.12.24.36 months
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.
Time frame: post-operative 1.3.6.12.24.36 months
hospital for special surgery (HSS) score. The maximum score of HSS is 100, higher score represents better result.
Time frame: post-operative 1.3.6.12.24.36 months
Harris score, The maximum score of Harris score is 100, higher score represents better result.
Time frame: post-operative 1.3.6.12.24.36 months
American Orthopaedic Foot & Ankle Society (AOFAS) score,The maximum score of AOFAS score is 100, higher score represents better result.
Contact information is provided by the study sponsor or research team.
Peking University Third Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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