Status:
NOT_YET_RECRUITING
Evaluation of the Safety and Efficacy of Artificial Bone Repair Materials for Repair of Long Bone Defects in the Extremities
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Bone Defects of the Limbs
Eligibility:
All Genders
18-60 years
Phase:
NA
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 Clinic...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT06959459
Start Date
May 10 2025
End Date
December 30 2026
Last Update
May 6 2025
Active Locations (1)
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1
Chinese PLA General Hosptial
Beijing, China