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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Bone Defects

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Traumatic bone defect in lower limb

3D printed prostheses

Intervention Type DEVICE

3D printed prostheses

Infective lower limb bone defect

3D printed prostheses

Intervention Type DEVICE

3D printed prostheses

Neoplastic bone defect in lower limb

3D printed prostheses

Intervention Type DEVICE

3D printed prostheses

Interventions

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3D printed prostheses

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No