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

Recruiting

• Conditions: Bone Defects
• Interventions: Device: 3D printed prostheses

• Registration Number: NCT06269354
• Lead Sponsor: Peking University Third Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study Start: 2023-11-01
• Study First Submitted: 2023-12-18
• Study First Submitted QC: 2024-02-20
• Last Update Submitted: 2024-02-20
• Study First Posted: 2024-02-21
• Last Update Posted: 2024-02-21
• Primary Completion: 2026-06-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neoplastic bone defect in lower limb	3D printed prostheses	Neoplastic bone defect in lower limb
Infective lower limb bone defect	3D printed prostheses	Infective lower limb bone defect
Traumatic bone defect in lower limb	3D printed prostheses	Traumatic bone defect in lower limb

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pain assessment	post-operative 1.3.6.12.24.36 months	Visual Analog Score (VAS), total score is 10, "0" represents no pain, "10" represents the most unbearable pain
Evaluation of life quality and health status.	post-operative 1.3.6.12.24.36 months	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.
Evaluation of hip function	post-operative 1.3.6.12.24.36 months	Harris score, The maximum score of Harris score is 100, higher score represents better result.
Evaluation of knee function	post-operative 1.3.6.12.24.36 months	hospital for special surgery (HSS) score. The maximum score of HSS is 100, higher score represents better result.
Evaluation of ankle function	post-operative 1.3.6.12.24.36 months	American Orthopaedic Foot \& Ankle Society (AOFAS) score，The maximum score of AOFAS score is 100, higher score represents better result.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Haidian, China