Multi-center Study on Comprehensive Diagnosis and Treatment of Lower Limb Bone Defect Based on Three-dimensional Printing Technology
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3D printed prostheses.
- Who it may be relevant to
- Registry conditions: Bone Defects. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device 3D printed prostheses
3D printed prostheses
Primary outcome measures
- Evaluation of implant stability, new bone growth- limb length [Time frame: post-operative 1.3.6.12.24.36 months]
- Evaluation of bone healing [Time frame: post-operative 3.6.12.24.36 months]
Secondary outcome measures (5)
- Pain assessment [Time frame: post-operative 1.3.6.12.24.36 months]
- Evaluation of life quality and health status. [Time frame: post-operative 1.3.6.12.24.36 months]
- Evaluation of knee function [Time frame: post-operative 1.3.6.12.24.36 months]
- Evaluation of hip function [Time frame: post-operative 1.3.6.12.24.36 months]
- Evaluation of ankle function [Time frame: post-operative 1.3.6.12.24.36 months]
Eligibility criteria
Inclusion criteria
- Patients with traumatic lower limb bone defect;
- Infected lower limb bone defect patients;
- Patients with neoplastic lower limb bone defect;
- The above reasons caused bone defects of more than 5CM
- at least 18 years of age;
- Sign an informed agreement and join the study cohort voluntarily.
Exclusion criteria
- Patients who do not agree to the use of 3D printed microporous titanium alloy prostheses;
- Patients who cannot tolerate surgery;
- the subjects cannot comply with the follow-up or affect the scientific and integrity of the study;
- Other patients who were not suitable for inclusion as assessed by clinicians.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Peking University Third Hospital — Beijing
Identifiers
NCT: NCT06269354 · 20231121-71479