Status:
SUSPENDED
A Clinical Study to Evaluate the Safety and Efficacy of Biologic Hollow Bone Screws
Lead Sponsor:
FengYafei
Conditions:
Fracture Fixation, Internal
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Traditional fracture fixation devices can cause corrosion, allergies, and stress shielding effects. They often require removal after healing, risking secondary damage. Recently, biodegradable material...
Detailed Description
Traditional fracture internal fixation devices implanted in the human body for a long time will cause corrosion, allergy and adverse effects due to stress shielding effect, etc. Due to the non-absorba...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Aged 18-75 years old (inclusive), both sexes;
- Patients with knee and ankle fractures requiring internal fixation confirmed by imaging examination;
- Voluntary participation in the clinical trial and signing of the informed consent.
- Exclusion criteria
- The following conditions exist at the fracture site: infection, osteofascial compartment syndrome, osteitis, pathological fracture, open fracture, severe tissue or vascular and nerve injury, or insufficient bone mass of the affected limb affecting screw implantation, etc.
- Abnormal liver and kidney function with clinical significance (ALT, AST 2 times the upper limit of normal value and Cr 2 times the upper limit of normal value);
- Abnormal coagulation function with clinical significance (APTT \> 2 times the upper limit of normal value);
- Patients with difficult-to-control diabetes (any blood glucose \> 11.1mmol/L or glycosylated hemoglobin \> 9%);
- Past allergies to silk protein materials;
- Mental illness;
- Patients who cannot guarantee to quit smoking during the fracture healing period;
- Pregnant or lactating women or women of childbearing age who plan to get pregnant within 6 months;
- Those who have participated in other pre-clinical trials within 1 month before the trial;
- Those who are considered inappropriate to participate in the clinical trial.
Exclusion
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06942247
Start Date
January 1 2024
End Date
December 30 2026
Last Update
August 11 2025
Active Locations (1)
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1
The First Affiliated Hospital of Air Force Medical University (Xijing Hospital)
Xi'an, Shaanxi, China, 710032