Back to results3D Geplante Osteosynthesen Mit Patientenspezifischen Zielvorrichtungen
Primary Purpose
Fracture of Humerus, Fracture of Ulna Radius, Fracture of Clavicle
Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
fracture fixation with patient specific guides
standard procedure of fracture fixation
Sponsored by
About this trial
This is an interventional treatment trial for Fracture of Humerus
Eligibility Criteria
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)
Sites / Locations
- Universital Hospital Zurich
- University Hospital Balgrist
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
patient specific guides
standard procedure
Arm Description
fracture fixation with 3D planning and use of patient-specific instruments
standard procedure of fracture Fixation without 3D planning and without use of patient-specific instruments
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
range of motion
range of Motion is postoperatively assessed and compared between interventional and control group
Full Information
NCT ID
NCT02826538
First Posted
June 30, 2016
Last Updated
July 11, 2019
Sponsor
Balgrist University Hospital
Collaborators
University of Zurich
1. Study Identification
Unique Protocol Identification Number
NCT02826538
Brief Title
3D Geplante Osteosynthesen Mit Patientenspezifischen Zielvorrichtungen
Official Title
Evaluation Der Intraoperativen Umsetzung Von 3D Geplanten Osteosynthesen Mit Patientenspezifischen Zielvorrichtungen Durch Eine Quantitative Postoperative Erfolgskontrolle
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
difficulties recruiting participants
Study Start Date
July 30, 2017 (Actual)
Primary Completion Date
May 10, 2019 (Actual)
Study Completion Date
May 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Balgrist University Hospital
Collaborators
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patient specific guides
Arm Type
Experimental
Arm Description
fracture fixation with 3D planning and use of patient-specific instruments
Arm Title
standard procedure
Arm Type
Active Comparator
Arm Description
standard procedure of fracture Fixation without 3D planning and without use of patient-specific instruments
Intervention Type
Device
Intervention Name(s)
fracture fixation with patient specific guides
Other Intervention Name(s)
MyOsteotomy
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
standard procedure of fracture fixation
Intervention Description
the standard procedure of fracure fixation for each fracture localisation is used as a standard of reference
Primary Outcome Measure Information:
Title
3D difference between preoperative plan and surgery
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
surgical outcome assesed by validated outcome instruments
Description
The surgical outcome is assessed by using specific validated outcome instruments for each fracture localisation, for example PRWE-score for wrist fractures.
Time Frame
12 months
Title
range of motion
Description
range of Motion is postoperatively assessed and compared between interventional and control group
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phillipp Furnstahl, PhD
Organizational Affiliation
Balgrist University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philipp Furnstahl, PhD
Organizational Affiliation
Balgrist University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Universital Hospital Zurich
City
Zurich
ZIP/Postal Code
8001
Country
Switzerland
Facility Name
University Hospital Balgrist
City
Zurich
ZIP/Postal Code
8008
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
3D Geplante Osteosynthesen Mit Patientenspezifischen Zielvorrichtungen
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