3D Geplante Osteosynthesen Mit Patientenspezifischen Zielvorrichtungen
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|ClinicalTrials.gov Identifier: NCT02826538|
Recruitment Status : Not yet recruiting
First Posted : July 11, 2016
Last Update Posted : June 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|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||Device: fracture fixation with patient specific guides Device: standard procedure of fracture fixation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation Der Intraoperativen Umsetzung Von 3D Geplanten Osteosynthesen Mit Patientenspezifischen Zielvorrichtungen Durch Eine Quantitative Postoperative Erfolgskontrolle|
|Estimated Study Start Date :||June 30, 2017|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: patient specific guides
fracture fixation with 3D planning and use of patient-specific instruments
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
Other Name: MyOsteotomy
Active Comparator: standard procedure
standard procedure of fracture Fixation without 3D planning and without use of patient-specific instruments
Device: standard procedure of fracture fixation
the standard procedure of fracure fixation for each fracture localisation is used as a standard of reference
- 3D difference between preoperative plan and surgery [ Time Frame: 12 months ]For each surgery the discrepancy of the postoperative result compared to the preoperative planning is calculated by measuring all 6 degrees of freedom (3xrotation, 3xtranslation). The discrepancy between a simulated perfect postoperative result and the actual postoperative result is assessed in degree (rotation) and millimeters (translation). These measures are used to compare the outcome of the two different study Groups.
- surgical outcome assesed by validated outcome instruments [ Time Frame: 12 months ]The surgical outcome is assessed by using specific validated outcome instruments for each fracture localisation, for example PRWE-score for wrist fractures.
- range of motion [ Time Frame: 12 months ]range of Motion is postoperatively assessed and compared between interventional and control group
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826538
|Contact: Philipp Furnstahl, PhD||+4144 510 76 firstname.lastname@example.org|
|Principal Investigator:||Phillipp Furnstahl, PhD||Balgrist University Hospital|