NCT02826538

3D Geplante Osteosynthesen Mit Patientenspezifischen Zielvorrichtungen

Evaluation Der Intraoperativen Umsetzung Von 3D Geplanten Osteosynthesen Mit Patientenspezifischen Zielvorrichtungen Durch Eine Quantitative Postoperative Erfolgskontrolle

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Balgrist University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Goal of this study is to evaluate the accuracy of 3D computer-planned fracture fixation with patient-specific instruments for clavicle, upper extremity, lower extremity and pelvis fractures compared with the standard procedure of fracture fixation.

Detailed description

The research hypothesis is: The medical product permits the fracture fixation of clavicle, upper extremity, lower extremity and pelvis fractures to be more accurate compared with standard procedures of fracture fixation. Accuracy is evaluated by calculating translation and rotation comparing the postoperative 3D model versus the preoperative 3D plan. Secondary outcome is an assessment of the surgical outcome using validated outcome instruments for each fractured body part like "Patient related wrist Evaluation" (PRWE) scores for distal radial fractures, as well as evaluation of range of motion.

Conditions

• Fracture of Humerus
• Fracture of Ulna Radius
• Fracture of Clavicle
• Fracture of Hand
• Fracture of Pelvis
• Fracture of Femur
• Fracture of Tibia Fibula
• Fracture of Skull

Interventions

Type	Name	Description
DEVICE	fracture fixation with patient specific guides	Using the preoperative computed tomography scan, a 3D planning of the fracture Fixation is made and patient-specific guides for fracure fixation are produced using a 3D Printer. These Patient-specific guides are used for fracture fixation
DEVICE	standard procedure of fracture fixation	the standard procedure of fracure fixation for each fracture localisation is used as a standard of reference

Timeline

• Start date: 2017-07-30
• Primary completion: 2019-05-10
• Completion: 2019-05-10
• First posted: 2016-07-11
• Last updated: 2019-07-12

Locations

2 sites across 1 country: Switzerland