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Treatment of Acetabulum Fracture With O'ARM Surgical Imaging

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.
 
ClinicalTrials.gov Identifier: NCT03040739
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief Summary:

Acetabulum fracture are high energy trauma in young people as it can be the result of a simple fall in elder people. This fracture generates an incongruity between acetabulum and femoral head. So surgery is recognized as the best treatment even if technically difficult because of the the complexity of anatomy.Navigation is widely used in orthopaedic surgery .

The aim of the study is to evaluate the effect of peroperative navigation system on reduction of the acetabulum articular surface


Condition or disease Intervention/treatment
Acetabulum Fracture Other: use of O'ARM imaging system

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Study Type : Observational [Patient Registry]
Actual Enrollment : 56 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Treatment of Acetabulum Fracture With O'ARM Surgical Imaging
Actual Study Start Date : July 8, 2016
Actual Primary Completion Date : January 1, 2017
Actual Study Completion Date : June 15, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
case Other: use of O'ARM imaging system
use of O'ARM imaging system

control Other: use of O'ARM imaging system
use of O'ARM imaging system




Primary Outcome Measures :
  1. Height of incongruity [ Time Frame: Day 1 ]
    Reduction of the articular surface of the acetabulum



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Every patients admitted in the service of orthopaedic surgery for fracture of the cotyle
Criteria

Inclusion Criteria:

  • Age >18 years
  • acetabulum fracture dating less than a month

Exclusion Criteria:

  • No exclusion criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03040739


Locations
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France
Groupe Hospitalier Paris Saint Joseph
Paris, Ile-de-France, France, 75014
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Additional Information:

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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT03040739    
Other Study ID Numbers: COTYLE_O'ARM
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Groupe Hospitalier Paris Saint Joseph:
O'ARM
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries