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

NCT ID: NCT06959459

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-10
• Study Completion Date: 2026-12-30

Brief Summary

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

Conditions

Bone Defects of the Limbs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Control group

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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

Interventions

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

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

Intervention Type: DEVICE

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

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhang Wei

Deputy head of orthopedics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chinese PLA General Hosptial

Beijing, , China

Countries

China

Central Contacts

Wei Zhang

Role: CONTACT

bszw@hotmail.com

+86 15334508850

Facility Contacts

Meng Li

Role: primary

limeng1@301.hospital.com.cn

Other Identifiers

2024QX008-KS002

Identifier Type: -

Identifier Source: org_study_id