Fracture Femur Clinical Trial
— 3DFRGOfficial title:
3D Planned Surgery of Acute Fractures Performed With 3D Guides Printed at the Point of Care - a Prospective Case Series
NCT number | NCT05741892 |
Other study ID # | 5364 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2023 |
Est. completion date | December 1, 2025 |
The aim of the study is to assess the accuracy of fracture reduction performed with surgical guides designed and 3D printed at the point of care in comminuted fractures of femur- and tibia-shaft.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | December 1, 2025 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Universitätsklinik für Orthopädische Chirurgie und Traumatologie | Bern |
Lead Sponsor | Collaborator |
---|---|
Insel Gruppe AG, University Hospital Bern |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rotational deviation (Axial plane deviation) in degree | Planned rotational alignment versus postoperative rotational alignment. | Between 1 to 7 days postoperative, depending on the patients status | |
Secondary | Length deviation in mm | Planed length versus postoperative length | Between 1 to 7 days postoperative, depending on the patients status | |
Secondary | Frontal plane deviation in degree | Planned varus/valgus alignment versus postoperative varus/valgus alignment | Between 1 to 7 days postoperative, depending on the patients status | |
Secondary | Sagittal plane deviation in degree | Planned flexion/extension of the proximal and distal fracture fragments compared to the postoperative position. | Between 1 to 7 days postoperative, depending on the patients status |