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Evaluation of the Safety and Efficacy of Artificial Bone Repair Materials for Repair of Long Bone Defects in the Extremities | Clinical Trials | Clareo Health

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

Evaluation of the Safety and Efficacy of Artificial Bone Repair Materials for Repair of Long Bone Defects in the Extremities: A Prospective, Randomized Controlled, Single-Blind, Non-Inferiority Clinical Trial

NCT06959459•Chinese PLA General Hospital

View on ClinicalTrials.gov

Summary

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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;
+5 more criteria

Locations (1)

Chinese PLA General Hosptial

Beijing, China

Key Dates

Start Date

May 10, 2025

Primary Completion Date

April 30, 2026

Completion Date

December 30, 2026

Last Updated

May 6, 2025

Enrollment

156

ESTIMATED participants

Conditions

Bone Defects of the Limbs

Interventions

Intervention Group:Use of artificial bone repair materials produced by Changzhou Bone-Renewal Medical Technologies LLC.

DEVICE

Control group: Use of β-tricalcium phosphate bioceramics produced by Shanghai Biolu Biomaterials Co., Ltd.

DEVICE

Contacts

Wei Zhang

CONTACT

+86 15334508850 bszw@hotmail.com