Evaluation of an Innovative Medical Device Supporting Orthopedic Surgical Interventions

Fracture of Distal End of Radius Clinical Trial

— VIPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01670344
• Other study ID #: 10308644 Final 2.5
• Status: Completed
• Phase: N/A
• First received: August 15, 2012
• Last updated: June 20, 2013
• Start date: July 2012
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Siemens Healthcare QT
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fracture of Distal End of Radius

Intervention

Procedure:
• Treatment with investigational method (virtual implant positioning system)

• Treatment with surgical standard of care

Locations

Country	Name	City	State
Germany	Siemens AG Healthcare Sector	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
Siemens Healthcare QT

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of screw replacements in both treatments arms	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)	Participants will be followed for the duration of the hospital stay, an expected average of 3 days	No
Secondary	Comparison of the investigational method to the standard of care regarding radiation time.		Participants will be followed for the duration of the hospital stay, an expected average of 3 days	No
Secondary	Number of adverse events and serious adverse events during the clinical investigarion.		Participants will be followed for the duration of the hospital stay, an expected average of 3 days	Yes