3D Geplante Osteosynthesen Mit Patientenspezifischen Zielvorrichtungen

Not Applicable

Terminated

• Conditions: Fracture of Hand; Fracture of Pelvis; Fracture of Skull; Fracture of Humerus; Fracture of Clavicle; Fracture of Tibia Fibula; Fracture of Ulna Radius; Fracture of Femur
• Interventions: Device: fracture fixation with patient specific guides; Device: standard procedure of fracture fixation

• Registration Number: NCT02826538
• Lead Sponsor: Balgrist University Hospital

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.

Study Timeline

• Study First Submitted: 2016-06-30
• Study First Submitted QC: 2016-07-05
• Study First Posted: 2016-07-11
• Study Start: 2017-07-30
• Primary Completion: 2019-05-10
• Study Completion: 2019-05-10
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-11
• Last Update Posted: 2019-07-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patient specific guides	fracture fixation with patient specific guides	fracture fixation with 3D planning and use of patient-specific instruments
standard procedure	standard procedure of fracture fixation	standard procedure of fracture Fixation without 3D planning and without use of patient-specific instruments

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
range of motion	12 months	range of Motion is postoperatively assessed and compared between interventional and control group
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.

Trial Locations

Locations (2)

University Hospital Balgrist; 🇨🇭 Zurich, Switzerland

Universital Hospital Zurich; 🇨🇭 Zurich, Switzerland