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Evaluation of an Innovative Medical Device Supporting Orthopedic Surgical Interventions (VIPS)

This study is currently recruiting participants.
Verified September 2012 by Siemens Healthcare QT
Sponsor:
Information provided by (Responsible Party):
Siemens Healthcare QT
ClinicalTrials.gov Identifier:
NCT01670344
First received: August 15, 2012
Last updated: September 5, 2012
Last verified: September 2012
History of Changes

August 15, 2012
September 5, 2012
July 2012
June 2013   (final data collection date for primary outcome measure)
Number of screw replacements in both treatments arms [ Time Frame: Participants will be followed for the duration of the hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
The number of screw replacements in both treatment arms will be assessed to evaluate the investigational method in comparison to the standard of care (arm B)
Same as current
Complete list of historical versions of study NCT01670344 on ClinicalTrials.gov Archive Site
  • Comparison of the investigational method to the standard of care regarding radiation time. [ Time Frame: Participants will be followed for the duration of the hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
  • Number of adverse events and serious adverse events during the clinical investigarion. [ Time Frame: Participants will be followed for the duration of the hospital stay, an expected average of 3 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluation of an Innovative Medical Device Supporting Orthopedic Surgical Interventions
Virtual Implant Planning System - A Method to Support Image-guided Surgical Interventions

This study is a randomized, controlled, 2-arm, open trial to evaluate an innovative positioning system in the clinical setting of orthopedic surgery.

Aim of the study is the validation and comparison of the innovative medical device with the current standard method.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Fracture of Distal End of Radius
  • Procedure: Treatment with investigational method (virtual implant positioning system)
  • Procedure: Treatment with surgical standard of care
  • A
    Treatment with investigational method (virtual implant positioning system)
    Intervention: Procedure: Treatment with investigational method (virtual implant positioning system)
  • B
    Treatment with surgical standard of care
    Intervention: Procedure: Treatment with surgical standard of care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with diastal fracture of the radius
  • Patients with the mentioned fracture and indication for surgical treatment according to national guidelines
  • Age >/= 18 years of age
  • Patients willing to participate and after having given their informed consent in written form

Exclusion Criteria:

  • Participation in other interventional clinical trials
  • Pregnant or lactating women
Both
18 Years and older
No
Contact: Gerhard Kleinszig, M.Sc. +49 9131 84 ext 0
Contact: Eva M Rueth, MD +49 9131 84 ext 0 eva-maria.rueth@siemens.com
Germany
 
NCT01670344
10308644 Final 2.5
No
Siemens Healthcare QT
Siemens Healthcare QT
Not Provided
Study Director: Kleinszig Gerhard, MSc Sponsor GmbH
Siemens Healthcare QT
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP