3D Geplante Osteosynthesen Mit Patientenspezifischen Zielvorrichtungen

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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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

Intervention / Treatment
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* Device: fracture fixation with patient specific guides
* Device: standard procedure of fracture fixation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient specific guides<br>fracture fixation with 3D planning and use of patient-specific instruments | Device: fracture fixation with patient specific guides<br>* 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<br>* Other names: MyOsteotomy;|
| Active Comparator: standard procedure<br>standard procedure of fracture Fixation without 3D planning and without use of patient-specific instruments | Device: standard procedure of fracture fixation<br>* the standard procedure of fracure fixation for each fracture localisation is used as a standard of reference<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3D difference between preoperative plan and surgery | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical outcome assesed by validated outcome instruments | The surgical outcome is assessed by using specific validated outcome instruments for each fracture localisation, for example PRWE-score for wrist fractures. | 12 months | 
| range of motion | range of Motion is postoperatively assessed and compared between interventional and control group | 12 months |