Reconstruction of Complex Proximal Humeral Fractures.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02052206
Recruitment Status : Completed
First Posted : February 3, 2014
Last Update Posted : November 27, 2017
Information provided by (Responsible Party):
Lazaros Vlachopoulos, MD, Balgrist University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Shoulder Complexe Proximal Humeral Fractures Procedure: Shoulder replacement surgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reconstruction of Complex Proximal Humeral Fractures.
Study Start Date : March 2014
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

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

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02052206

University Hospital Balgrist
Zurich, Switzerland
Sponsors and Collaborators
Balgrist University Hospital
Study Chair: Lazaros Vlachopoulos, MD Balgrist University Hospital

Responsible Party: Lazaros Vlachopoulos, MD, MD, Balgrist University Hospital Identifier: NCT02052206     History of Changes
Other Study ID Numbers: BalgristUH_CARD_03
First Posted: February 3, 2014    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017

Keywords provided by Lazaros Vlachopoulos, MD, Balgrist University Hospital:
complexe proximal humeral fracture
shoulder replacement

Additional relevant MeSH terms:
Fractures, Bone
Humeral Fractures
Shoulder Fractures
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Wounds and Injuries
Arm Injuries
Shoulder Injuries