Multi-center Study on Comprehensive Diagnosis and Treatment of Lower Limb Bone Defect Based on Three-dimensional Printing Technology

Peking University

Status: Enrolling

Conditions: Bone Defects

Treatments: Device: 3D printed prostheses

Study type: Observational

Funder types: Other

Identifiers

NCT06269354

20231121-71479

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with traumatic lower limb bone defect;
2. Infected lower limb bone defect patients;
3. Patients with neoplastic lower limb bone defect;
4. The above reasons caused bone defects of more than 5CM
5. at least 18 years of age;
6. Sign an informed agreement and join the study cohort voluntarily.

Exclusion criteria

1. Patients who do not agree to the use of 3D printed microporous titanium alloy prostheses;
2. Patients who cannot tolerate surgery;
3. the subjects cannot comply with the follow-up or affect the scientific and integrity of the study;
4. Other patients who were not suitable for inclusion as assessed by clinicians.

Trial design

120 participants in 3 patient groups

Traumatic bone defect in lower limb

Description:

Traumatic bone defect in lower limb

Treatment:

Device: 3D printed prostheses

Infective lower limb bone defect

Description:

Infective lower limb bone defect

Treatment:

Device: 3D printed prostheses

Neoplastic bone defect in lower limb

Description:

Neoplastic bone defect in lower limb

Treatment:

Device: 3D printed prostheses