Reconstruction of Complex Proximal Humeral Fractures.

November 24, 2017 updated by: Lazaros Vlachopoulos, MD, Balgrist University Hospital
The purpose of this study is to evaluate the accuracy of shoulder replacement surgery in realization a computer assisted 3D planning compared to conventional 2D planning.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland
        • University Hospital Balgrist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • osteoarthritis or complexe proximal humeral fracture and indication for shoulder arthroplasty
  • patients > 18years

Exclusion Criteria:

  • contraindication for computertomography
  • pregnancy
  • previous fracture or shoulder replacement of the contralateral side in case of a complexe proximal humeral fracture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Computer-assisted 3D planning
Realization of the fracture reconstruction according to the computer-assisted 3D preoperative plan
Procedure: Shoulder replacement surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative analysis of the accuracy of an automatic algorithm for the reconstruction of proximal humeral fractures
Time Frame: 6 weeks
Accuracy of the reconstruction of complex proximal humeral fractures.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Balgrist University Hospital

Investigators

  • Study Chair: Lazaros Vlachopoulos, MD, Balgrist University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

January 30, 2014

First Submitted That Met QC Criteria

January 31, 2014

First Posted (Estimate)

February 3, 2014

Study Record Updates

Last Update Posted (Actual)

November 27, 2017

Last Update Submitted That Met QC Criteria

November 24, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BalgristUH_CARD_03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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