Evaluation of an Innovative Medical Device Supporting Orthopedic Surgical Interventions

Not Applicable

Completed

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

• Registration Number: NCT01670344
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-15
• Study First Submitted QC: 2012-08-21
• Study First Posted: 2012-08-22
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-20
• Last Update Posted: 2013-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Treatment with investigational method (virtual implant positioning system)	Treatment with investigational method (virtual implant positioning system)
B	Treatment with surgical standard of care	Treatment with surgical standard of care

Primary Outcome Measures

Name	Time	Method
Number of screw replacements in both treatments arms	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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Siemens AG Healthcare Sector; 🇩🇪 Erlangen, Germany