Clinical trial NCT06959459: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bone Defects of the Limbs
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Bone graft fusion rate
timeFrame: 24weeks after surgery
Secondary outcomes:
measure: Bone defect healing rate
timeFrame: 4 and 12 weeks after surgery
measure: New bone formation rate
timeFrame: 4, 12 and 24 weeks after surgery
measure: SF-36 scale
timeFrame: 24 weeks after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hosptial
Study officials:
References: