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OpenTrials
Completed

NCT Number: NCT01670344

Evaluation of an Innovative Medical Device Supporting Orthopedic 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.

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Key information

Conditions

Fracture of Distal End of Radius

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Siemens AG Healthcare Sector

Erlangen, 91052, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment with investigational method (virtual implant positioning system)

Procedure

Treatment with surgical standard of care

Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Siemens Healthcare QT

Industry

Registry information

Official study title

Virtual Implant Planning System - A Method to Support Image-guided Surgical Interventions

Acronym: VIPS

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 22, 2012
Registry last updated
Jun 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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