3D Geplante Osteosynthesen Mit Patientenspezifischen Zielvorrichtungen

Fracture of Femur Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02826538
• Other study ID #: 3D-Osteosynthese-Ziel
• Status: Terminated
• Phase: N/A
• Start date: July 30, 2017
• Est. completion date: May 10, 2019

Study information

• Verified date: July 2019
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Femoral Fractures
• 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
• Fractures, Bone
• Hip Fractures
• Humeral Fractures
• Skull Fractures
• Tibial Fractures
• Ulna Fractures

Intervention

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
• standard procedure of fracture fixation
the standard procedure of fracure fixation for each fracture localisation is used as a standard of reference

Locations

Country	Name	City	State
Switzerland	Universital Hospital Zurich	Zurich
Switzerland	University Hospital Balgrist	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Balgrist University Hospital	University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

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