Fracture of Femur Clinical Trial
Official title:
Evaluation Der Intraoperativen Umsetzung Von 3D Geplanten Osteosynthesen Mit Patientenspezifischen Zielvorrichtungen Durch Eine Quantitative Postoperative Erfolgskontrolle
Verified date | July 2019 |
Source | Balgrist University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 7 |
Est. completion date | May 10, 2019 |
Est. primary completion date | May 10, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Switzerland | Universital Hospital Zurich | Zurich | |
Switzerland | University Hospital Balgrist | Zurich |
Lead Sponsor | Collaborator |
---|---|
Balgrist University Hospital | University of Zurich |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | range of motion | range of Motion is postoperatively assessed and compared between interventional and control group | 12 months |
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