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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02826538
Other study ID # 3D-Osteosynthese-Ziel
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
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