NCT01670344

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 21, 2013

Status Verified

June 1, 2013

Enrollment Period

11 months

First QC Date

August 15, 2012

Last Update Submit

June 20, 2013

Conditions

Fracture of Distal End of Radius

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • 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

Study Arms (2)

A

OTHER

Treatment with investigational method (virtual implant positioning system)

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

B

OTHER

Treatment with surgical standard of care

Procedure: Treatment with surgical standard of care

Interventions

Treatment with investigational method (virtual implant positioning system)PROCEDURE
A
Treatment with surgical standard of carePROCEDURE
B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Participation in other interventional clinical trials
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siemens AG Healthcare Sector

Erlangen, 91052, Germany

Location

MeSH Terms

Interventions

Therapeutics

Study Officials

  • Kleinszig Gerhard, MSc

    Sponsor GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2012

First Posted

August 22, 2012

Study Start

July 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 21, 2013

Record last verified: 2013-06

Locations

DE(1)