Fracture of Clavicle, Fracture of Femur, Fracture of Hand, Fracture of Humerus, Fracture of Pelvis, Fracture of Skull, Fracture of Tibia Fibula, Fracture of Ulna Radius
Conditions
Brief 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.
Interventions
DEVICEfracture 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
DEVICEstandard procedure of fracture fixation
the standard procedure of fracure fixation for each fracture localisation is used as a standard of reference
Sponsors
University of Zurich
Balgrist University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* fracture of clavicle, upper extremity, lower extremity or pelvis,tibia, fibula,Femur, with indication for fracture Fixation * clinical indication for a computed tomography of the fractured bone * \>18 years of Age * Patient is able to give informed consent
Exclusion criteria
* pregnancy or nursing women * non-compliance of the patient to follow the clinical study protocol, drug abuse or alcohol abuse * participation in a different clinical Trial within the last 30 days before inclusion or during the study * allergy to Polyamid PA 2200 * no available technique for fracture Fixation which could be performed, in case of applying the medical device is not possible. * Applying the medical device is not possible, because of technical or anatomical reasons. * other clinical significant accompanying symptoms (tumor, infection)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3D difference between preoperative plan and surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| surgical outcome assesed by validated outcome instruments | 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 | 12 months | range of Motion is postoperatively assessed and compared between interventional and control group |
Countries
Switzerland
Outcome results
None listed