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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Bone Defects of the Limbs
• Intervention / Treatment: 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
• Enrollment (Estimated): 156
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei Zhang; Phone Number: +86 15334508850; Email: bszw@hotmail.com

Study Locations

• China
  • Beijing, China
    • Chinese PLA General Hosptial
    • Contact: Meng Li; Email: limeng1@301.hospital.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Use of artificial bone repair materials produced by Changzhou Bone-Renewal Medical Technologies LLC.	Device: 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.
Active Comparator: Control group; Use of β-tricalcium phosphate bioceramics produced by Shanghai Biolu Biomaterials Co., Ltd.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bone graft fusion rate	24weeks after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Bone defect healing rate	4 and 12 weeks after surgery
New bone formation rate	4, 12 and 24 weeks after surgery
SF-36 scale	24 weeks after surgery

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 10, 2025
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: April 28, 2025
• First Submitted That Met QC Criteria: May 5, 2025
• First Posted (Estimated): May 6, 2025

Study Record Updates

• Last Update Posted (Estimated): May 6, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2024QX008-KS002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No