3D Geplante Osteosynthesen Mit Patientenspezifischen Zielvorrichtungen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02826538
Recruitment Status : Not yet recruiting
First Posted : July 11, 2016
Last Update Posted : June 8, 2017
University of Zurich
Information provided by (Responsible Party):
Balgrist University Hospital

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.

Condition or disease Intervention/treatment Phase
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 Device: fracture fixation with patient specific guides Device: standard procedure of fracture fixation Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation Der Intraoperativen Umsetzung Von 3D Geplanten Osteosynthesen Mit Patientenspezifischen Zielvorrichtungen Durch Eine Quantitative Postoperative Erfolgskontrolle
Estimated Study Start Date : June 30, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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 Name: 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

Primary Outcome Measures :
  1. 3D difference between preoperative plan and surgery [ Time Frame: 12 months ]
    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 :
  1. surgical outcome assesed by validated outcome instruments [ Time Frame: 12 months ]
    The surgical outcome is assessed by using specific validated outcome instruments for each fracture localisation, for example PRWE-score for wrist fractures.

  2. range of motion [ Time Frame: 12 months ]
    range of Motion is postoperatively assessed and compared between interventional and control group

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02826538

Contact: Philipp Furnstahl, PhD +4144 510 76 30

Sponsors and Collaborators
Balgrist University Hospital
University of Zurich
Principal Investigator: Phillipp Furnstahl, PhD Balgrist University Hospital

Responsible Party: Balgrist University Hospital Identifier: NCT02826538     History of Changes
Other Study ID Numbers: 3D-Osteosynthese-Ziel
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hip Fractures
Fractures, Bone
Femoral Fractures
Humeral Fractures
Tibial Fractures
Skull Fractures
Ulna Fractures
Wounds and Injuries
Leg Injuries
Arm Injuries
Hip Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Forearm Injuries