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

NCT06269354 | Recruiting DMC

• 1 other identifier: 20231121-71479
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Defects

Keywords

3D printing technology; bone defects; clinical effects

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Pain assessment

  post-operative 1.3.6.12.24.36 months

• Evaluation of life quality and health status.

  post-operative 1.3.6.12.24.36 months

• Evaluation of knee function

  post-operative 1.3.6.12.24.36 months

• Evaluation of hip function

  post-operative 1.3.6.12.24.36 months

• Evaluation of ankle function

  post-operative 1.3.6.12.24.36 months

Study Arms (3)

Traumatic bone defect in lower limb

Traumatic bone defect in lower limb

Device: 3D printed prostheses

Infective lower limb bone defect

Infective lower limb bone defect

Device: 3D printed prostheses

Neoplastic bone defect in lower limb

Neoplastic bone defect in lower limb

Device: 3D printed prostheses

Interventions

3D printed prostheses DEVICE

3D printed prostheses

Infective lower limb bone defect; Neoplastic bone defect in lower limb; Traumatic bone defect in lower limb

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with lower limb defects

You may qualify if:

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

You may not qualify if:

• Patients who do not agree to the use of 3D printed microporous titanium alloy prostheses;
• Patients who cannot tolerate surgery;
• the subjects cannot comply with the follow-up or affect the scientific and integrity of the study;

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Haidian, China

RECRUITING

Central Study Contacts

Bingchuan Liu, Doctor

CONTACT

+86 18310188678; liubc@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: February 21, 2024
• Study Start: November 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 21, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)