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

Chinese PLA General Hospital (301 Hospital)

Status: Not yet enrolling

Conditions: Bone Defects of the Limbs

Treatments: Device: 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.

Study type: Interventional

Funder types: Other

Identifiers

NCT06959459

2024QX008-KS002

Details and patient eligibility

About

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

Enrollment: 156 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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;
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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156 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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

Treatment:

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

Control group

Active Comparator group

Description:

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

Treatment:

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