3D Geplante Osteosynthesen Mit Patientenspezifischen Zielvorrichtungen

Evaluation Der Intraoperativen Umsetzung Von 3D Geplanten Osteosynthesen Mit Patientenspezifischen Zielvorrichtungen Durch Eine Quantitative Postoperative Erfolgskontrolle

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.

Study Overview

• Status: Terminated
• Conditions: Fracture of Clavicle; Fracture of Femur; Fracture of Humerus; Fracture of Ulna Radius; Fracture of Hand; Fracture of Pelvis; Fracture of Tibia Fibula; Fracture of Skull
• Intervention / Treatment: Device: fracture fixation with patient specific guides; Device: 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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8008
    • University Hospital Balgrist
  • Zurich, Switzerland, 8001
    • Universital Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: patient specific guides; fracture fixation with 3D planning and use of patient-specific instruments	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; Other Names: MyOsteotomy
ACTIVE_COMPARATOR: standard procedure; standard procedure of fracture Fixation without 3D planning and without use of patient-specific instruments	Device: standard procedure of fracture fixation; the standard procedure of fracure fixation for each fracture localisation is used as a standard of reference

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
range of motion	range of Motion is postoperatively assessed and compared between interventional and control group	12 months

Collaborators and Investigators

• Sponsor: Balgrist University Hospital
• Collaborators: University of Zurich
• Investigators: Principal Investigator: Phillipp Furnstahl, PhD, Balgrist University Hospital; Study Director: Philipp Furnstahl, PhD, Balgrist University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 30, 2017
• Primary Completion (ACTUAL): May 10, 2019
• Study Completion (ACTUAL): May 10, 2019

Study Registration Dates

• First Submitted: June 30, 2016
• First Submitted That Met QC Criteria: July 5, 2016
• First Posted (ESTIMATE): July 11, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Hip Injuries; Arm Injuries; Femoral Fractures; Fractures, Bone; Hip Fractures; Tibial Fractures; Humeral Fractures
• Other Study ID Numbers: 3D-Osteosynthese-Ziel

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No