Clinical trial NCT02826538: 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
Overall status: TERMINATED
Phase: NA
Conditions: 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
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2016-07-11
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: 3D difference between preoperative plan and surgery
timeFrame: 12 months
Secondary outcomes:
measure: surgical outcome assesed by validated outcome instruments
timeFrame: 12 months
measure: range of motion
timeFrame: 12 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Universital Hospital Zurich
city: Zurich
country: Switzerland
facility: University Hospital Balgrist
Study officials:
affiliation: Balgrist University Hospital
name: Phillipp Furnstahl, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Balgrist University Hospital
name: Philipp Furnstahl, PhD
role: STUDY_DIRECTOR
References: