3D Geplante Osteosynthesen Mit Patientenspezifischen Zielvorrichtungen

Balgrist University Hospital

Status: Terminated

Conditions: Fracture of Pelvis; Fracture of Tibia Fibula; Fracture of Skull; Fracture of Ulna Radius; Fracture of Humerus; Fracture of Hand; Fracture of Clavicle; Fracture of Femur

Treatments: Device: fracture fixation with patient specific guides; Device: standard procedure of fracture fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT02826538

3D-Osteosynthese-Ziel

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

patient specific guides

Experimental group

Description:

fracture fixation with 3D planning and use of patient-specific instruments

Treatment:

Device: fracture fixation with patient specific guides

standard procedure

Active Comparator group

Description:

standard procedure of fracture Fixation without 3D planning and without use of patient-specific instruments

Treatment:

Device: standard procedure of fracture fixation