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difficulties recruiting participants
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| Name | Class |
|---|---|
| University of Zurich | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patient specific guides | Experimental | fracture fixation with 3D planning and use of patient-specific instruments |
|
| standard procedure | Active Comparator | standard procedure of fracture Fixation without 3D planning and without use of patient-specific instruments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fracture fixation with patient specific guides | Device | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillipp Furnstahl, PhD | Balgrist University Hospital | Principal Investigator |
| Philipp Furnstahl, PhD | Balgrist University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universital Hospital Zurich | Zurich | 8001 | Switzerland | |||
| University Hospital Balgrist |
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| standard procedure of fracture fixation | Device | the standard procedure of fracure fixation for each fracture localisation is used as a standard of reference |
|
range of Motion is postoperatively assessed and compared between interventional and control group
| 12 months |
| Zurich |
| 8008 |
| Switzerland |
| ID | Term |
|---|---|
| D006810 | Humeral Fractures |
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D012887 | Skull Fractures |
| ID | Term |
|---|---|
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D005592 | Fracture Fixation |
| ID | Term |
|---|---|
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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