3D printed surgical guides for treating acute fractures
3D Planned Surgery of Acute Fractures Performed With 3D Guides Printed at the Point of Care - a Prospective Case Series
This study is testing whether 3D printed surgical guides made right at the hospital can help doctors fix broken bones in the leg more accurately and quickly, especially in urgent situations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT05741892 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of using 3D printed surgical guides, created at the point of care, for the accurate reduction of comminuted fractures in the femur and tibia. Traditional methods often involve long wait times for external production of these guides, which is impractical for acute cases requiring immediate surgical intervention. By utilizing 3D printing technology, the study aims to enhance surgical precision and reduce the incidence of postoperative malrotation, which can lead to poor outcomes and the need for revision surgeries. The research builds on previous feasibility studies that demonstrated the accuracy of this approach in controlled settings.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 99 with comminuted shaft fractures of the tibia or femur who are willing to undergo surgical treatment.
Not a fit: Patients with abnormal contralateral bony anatomy, pregnancy, acute tumors, or infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve surgical outcomes for patients with acute comminuted fractures by reducing malrotation and the need for revision surgeries.
How similar studies have performed: Previous studies have shown promising results with 3D printed guides in controlled settings, indicating potential for success in clinical applications.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Age between 18 and 99 years * Comminuted shaft fracture of tibia or femur * Intact contralateral tibia or femur * Patient willing to participate and sign the informed consent * Clear indication of surgical treatment Exclusion criteria: * Refusal to sign the informed consent * Abnormal contralateral bony anatomy (previous surgeries, poliomyelitis, previous injury, implants) * Pregnancy * Acute tumor or previous tumor disease * Acute infection
Where this trial is running
Bern
- Universitätsklinik für Orthopädische Chirurgie und Traumatologie — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Hecker Andreas, MD — Universitätsklinik für Orthopädische Chirurgie und Traumatologie
- Study coordinator: Hecker Andreas, MD
- Email: andreas.hecker@insel.ch
- Phone: 031 632 21 11
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.