Evaluation of biodegradable bone screws for fracture fixation
A Clinical Study to Evaluate the Safety and Efficacy of Biologic Hollow Bone Screws
This study is testing new biodegradable bone screws made from silk protein to see if they can safely help heal knee and ankle fractures without needing a second surgery like traditional metal screws.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT06942247 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the safety and efficacy of biologic hollow bone screws made from natural silk protein for internal fixation of knee and ankle fractures. Traditional fixation devices often require removal after healing, leading to complications, while biodegradable materials aim to eliminate the need for a second surgery and associated risks. The study compares these new screws to conventional fixation methods to assess their performance in promoting fracture healing without the drawbacks of metal devices. Participants will be monitored for safety and effectiveness throughout the trial.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18-75 with knee or ankle fractures requiring internal fixation.
Not a fit: Patients with infections, severe tissue injuries, or significant comorbidities affecting healing may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for additional surgeries and associated complications for patients with fractures.
How similar studies have performed: Previous studies have shown promise with biodegradable materials in fracture fixation, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria 1. Aged 18-75 years old (inclusive), both sexes; 2. Patients with knee and ankle fractures requiring internal fixation confirmed by imaging examination; 3. Voluntary participation in the clinical trial and signing of the informed consent. Exclusion criteria 1. 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. 2. 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); 3. Abnormal coagulation function with clinical significance (APTT \> 2 times the upper limit of normal value); 4. Patients with difficult-to-control diabetes (any blood glucose \> 11.1mmol/L or glycosylated hemoglobin \> 9%); 5. Past allergies to silk protein materials; 6. Mental illness; 7. Patients who cannot guarantee to quit smoking during the fracture healing period; 8. Pregnant or lactating women or women of childbearing age who plan to get pregnant within 6 months; 9. Those who have participated in other pre-clinical trials within 1 month before the trial; 10. Those who are considered inappropriate to participate in the clinical trial.
Where this trial is running
Xi'an, Shaanxi
- The First Affiliated Hospital of Air Force Medical University (Xijing Hospital) — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Study coordinator: Yafei Feng, Doctor
- Email: fengyafei2005@163.com
- Phone: +86 15829552527
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.