Evaluation of the Safety and Efficacy of Artificial Bone Repair Materials for Repair of Long Bone Defects in the Extremities

Launched by CHINESE PLA GENERAL HOSPITAL · May 5, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new type of artificial material designed to help repair bone defects in the arms and legs. The researchers want to find out if this material is safe to use and if it works as well as other treatments currently available. The trial is not yet recruiting participants, but when it starts, it will focus on adults aged 18 to 60 who have specific types of bone defects that need treatment. To be eligible, participants must have a single bone defect that is between 1 and 8 cubic centimeters in size.

If you or someone you know is interested in participating, it’s important to know that there are certain health conditions that would prevent someone from joining the trial, such as active infections or serious health issues. Participants will be required to understand the study and sign a consent form before taking part. This trial aims to provide valuable information that could improve how we treat bone defects in the future, and your involvement could help make a difference.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years old and ≤ 60 years old, regardless of sex;
• • 2. Cavitary bone defects in the limbs requiring bone grafting treatment;
• • 3. Bone defect volume ≥ 1 cm³ and ≤ 8 cm³, with only one bone defect requiring intervention;
• • 4. Subjects or their legal guardians can understand the study objectives, demonstrate sufficient compliance with the study protocol, and sign the informed consent form.
• Exclusion Criteria:
• • 1. Open fractures with wound contamination;
• • 2. Repair of infectious bone defects;
• • 3. Structural bone grafting required at the defect site;
• • 4. Osteofascial compartment syndrome in the affected limb scheduled for surgery;
• • 5. Presence of systemic infection, uncontrolled local infection at the surgical site, malignant tumor (including metastatic tumors) at the defect site, osteonecrosis at the defect site, severe nerve/soft tissue/vascular injury at the defect site, confirmed severe malnutrition, or dysfunction/failure of other vital organs;
• • 6. Calcium and phosphorus metabolic abnormalities (calcium/phosphorus levels \> 1.5 times the upper limit of normal values);
• • 7. History of diabetes with fasting blood glucose ≥ 6.1 mmol/L;
• • 8. Coagulation dysfunction (prothrombin time \[PT\] or activated partial thromboplastin time \[APTT\] \> 2 times the upper limit of normal values);
• • 9. Use of chemotherapeutic agents or receipt of radiotherapy within 3 months prior to enrollment;
• • 10. Cumulative use of corticosteroids or growth factors for ≥ 14 days within 1 month prior to enrollment;
• • 11. Long-term use of sedative-hypnotic drugs (continuous use for \> 3 months) or non-steroidal anti-inflammatory drugs (NSAIDs, continuous use for \> 3 months);
• • 12. Known allergy to bovine-derived materials or collagen products;
• • 13. Pregnant or lactating females;
• • 14. Participation in other interventional clinical trials for drugs or medical devices within 1 month prior to enrollment;
• • 15. Any other conditions where investigators, in their professional judgment, deem the subject ineligible to participate in the trial for the subject's safety or benefit.