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

Official title

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

Overview

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

Interventions

• 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.
• 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.

Primary outcome measures

• Bone graft fusion rate [Time frame: 24weeks after surgery]

Secondary outcome measures (3)

• Bone defect healing rate [Time frame: 4 and 12 weeks after surgery]
• New bone formation rate [Time frame: 4, 12 and 24 weeks after surgery]
• SF-36 scale [Time frame: 24 weeks after surgery]

Eligibility criteria

Inclusion criteria

• Age ≥ 18 years old and ≤ 60 years old, regardless of sex;
• Cavitary bone defects in the limbs requiring bone grafting treatment;
• Bone defect volume ≥ 1 cm³ and ≤ 8 cm³, with only one bone defect requiring intervention;
• 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

• Open fractures with wound contamination;
• Repair of infectious bone defects;
• Structural bone grafting required at the defect site;
• Osteofascial compartment syndrome in the affected limb scheduled for surgery;
• 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;
• Calcium and phosphorus metabolic abnormalities (calcium/phosphorus levels > 1.5 times the upper limit of normal values);
• History of diabetes with fasting blood glucose ≥ 6.1 mmol/L;
• Coagulation dysfunction (prothrombin time \[PT\] or activated partial thromboplastin time \[APTT\] > 2 times the upper limit of normal values);
• Use of chemotherapeutic agents or receipt of radiotherapy within 3 months prior to enrollment;
• Cumulative use of corticosteroids or growth factors for ≥ 14 days within 1 month prior to enrollment;
• Long-term use of sedative-hypnotic drugs (continuous use for > 3 months) or non-steroidal anti-inflammatory drugs (NSAIDs, continuous use for > 3 months);
• Known allergy to bovine-derived materials or collagen products;
• Pregnant or lactating females;
• Participation in other interventional clinical trials for drugs or medical devices within 1 month prior to enrollment;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Chinese PLA General Hosptial — Beijing

Identifiers

NCT: NCT06959459 · 2024QX008-KS002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗