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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Siemens Healthcare QT
ClinicalTrials.gov Identifier:
NCT01670344
First received: August 15, 2012
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

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 Intervention
Fracture of Distal End of Radius
Procedure: Treatment with investigational method (virtual implant positioning system)
Procedure: Treatment with surgical standard of care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Virtual Implant Planning System - A Method to Support Image-guided Surgical Interventions

Further study details as provided by Siemens Healthcare QT:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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 ]

Enrollment: 80
Study Start Date: July 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670344

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

No publications provided

Responsible Party: Siemens Healthcare QT
ClinicalTrials.gov Identifier: NCT01670344     History of Changes
Other Study ID Numbers: 10308644 Final 2.5
Study First Received: August 15, 2012
Last Updated: June 20, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on August 28, 2014