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NCT Number: NCT06269354

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.

Recruiting

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Key information

Conditions

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Other patients who were not suitable for inclusion as assessed by clinicians.

Treatment and study plan

3D printed prostheses

Device

3D printed prostheses

Primary outcomes

  1. Evaluation of implant stability, new bone growth- limb length

    Time frame: post-operative 1.3.6.12.24.36 months

    X-ray X、CT images

  2. Evaluation of bone healing

    Time frame: post-operative 3.6.12.24.36 months

    computed tomography (CT)

Secondary outcomes

  1. Pain assessment

    Time frame: 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

  2. Evaluation of life quality and health status.

    Time frame: 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.

  3. Evaluation of knee function

    Time frame: 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.

  4. Evaluation of hip function

    Time frame: post-operative 1.3.6.12.24.36 months

    Harris score, The maximum score of Harris score is 100, higher score represents better result.

  5. Evaluation of ankle function

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bingchuan Liu, Doctor

CONTACT

[email protected]

+86 18310188678

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2024
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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