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

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ClinicalTrials.gov Identifier: NCT01670344
Recruitment Status : Completed
First Posted : August 22, 2012
Last Update Posted : June 21, 2013
Sponsor:
Information provided by (Responsible Party):
Siemens Healthcare QT

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Fracture of Distal End of Radius Procedure: Treatment with investigational method (virtual implant positioning system) Procedure: Treatment with surgical standard of care Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Virtual Implant Planning System - A Method to Support Image-guided Surgical Interventions
Study Start Date : July 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
A
Treatment with investigational method (virtual implant positioning system)
Procedure: Treatment with investigational method (virtual implant positioning system)
B
Treatment with surgical standard of care
Procedure: Treatment with surgical standard of care



Primary Outcome Measures :
  1. 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 ]
    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)


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


Information from the National Library of Medicine

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT01670344


Locations
Germany
Siemens AG Healthcare Sector
Erlangen, Germany, 91052
Sponsors and Collaborators
Siemens Healthcare QT
Investigators
Study Director: Kleinszig Gerhard, MSc Sponsor GmbH

Responsible Party: Siemens Healthcare QT
ClinicalTrials.gov Identifier: NCT01670344     History of Changes
Other Study ID Numbers: 10308644 Final 2.5
First Posted: August 22, 2012    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013