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

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.

Study Overview

• Status: Recruiting
• Conditions: Bone Defects
• Intervention / Treatment: Device: 3D printed prostheses

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Bingchuan Liu, Doctor; Phone Number: +86 18310188678; Email: liubc@bjmu.edu.cn

Study Locations

• China
  • Haidian
    • Beijing, Haidian, China
      • Recruiting
      • Peking University Third Hospital
      • Contact: Bingchuan Liu; Phone Number: +86 18310188678; Email: liubc@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with lower limb defects

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Traumatic bone defect in lower limb	Device: 3D printed prostheses; 3D printed prostheses
Infective lower limb bone defect	Device: 3D printed prostheses; 3D printed prostheses
Neoplastic bone defect in lower limb	Device: 3D printed prostheses; 3D printed prostheses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of implant stability, new bone growth- limb length	X-ray X、CT images	post-operative 1.3.6.12.24.36 months
Evaluation of bone healing	computed tomography (CT)	post-operative 3.6.12.24.36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Estimated): February 21, 2024

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: 3D printing technology; bone defects; clinical effects
• Other Study ID Numbers: 20231121-71479

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No