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

Bone Defects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06269354
• Other study ID #: 20231121-71479
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: Peking University Third Hospital
• Contact: Bingchuan Liu, Doctor
• Phone: +86 18310188678
• Email: liubc[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Defects

Intervention

Device:
• 3D printed prostheses
3D printed prostheses

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Haidian

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of implant stability, new bone growth- limb length	X-ray X?CT images	post-operative 1.3.6.12.24.36 months
Primary	Evaluation of bone healing	computed tomography (CT)	post-operative 3.6.12.24.36 months
Secondary	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
Secondary	Evaluation of life quality and health status.	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
Secondary	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
Secondary	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
Secondary	Evaluation of ankle function	American Orthopaedic Foot & Ankle Society (AOFAS) score,The maximum score of AOFAS score is 100, higher score represents better result.	post-operative 1.3.6.12.24.36 months