Evaluation of biodegradable bone screws for fracture fixation
Official title: A Clinical Study to Evaluate the Safety and Efficacy of Biologic Hollow Bone Screws
Run by Xijing Hospital · NCT06942247 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT06942247 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals aged 18-75 with knee or ankle fractures requiring internal fixation.
✕Probably not a fit
Patients with infections, severe tissue injuries, or significant comorbidities affecting healing may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promise with biodegradable materials in fracture fixation, indicating potential for success in this novel approach.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Elastic nailing with Kirschner wires versus plate fixation for distal tibial fractures in adolescents
This trial tests whether elastic stable intramedullary nailing with Kirschner wires works as well as plate fixation for fixing distal tibial fractures in kids aged 10 to 16.
-
7-day oral antibiotic after surgery for people with diabetes and lower-leg fractures.
This trial will test whether taking a 7-day antibiotic pill after surgery lowers wound infection risk in adults with poorly controlled diabetes who had surgery to fix a broken bone in the lower leg, ankle, or foot.
-
Lidocaine During Surgery to See If It Lowers Opioid Use in Kids with Arm Fractures
In children aged 3–18 having surgery for upper-extremity fractures, this study tests whether giving IV lidocaine during the operation reduces the amount of opioid pain medicine needed after surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.