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NCT03478189 Clinical Trial

The Added Value of Intraoperative CT Scanner and Screw Navigation in Operative Treatment of Displaced Acetabular Fracture With Dome Impaction

Acetabular Fracture Clinical Trial

Official title:
The Added Value of Intraoperative CT Scanner and Screw Navigation in Operative Treatment of Displaced Acetabular Fracture With Dome Impaction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03478189
Other study ID # OARM impactionTOIT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 8, 2017
Est. completion date December 31, 2019

Study information
Verified date February 2020
Source Groupe Hospitalier Paris Saint Joseph
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The acetabulum fracture result from a trauma with high energy at the young adult or from a trauma of low energy at the old osteoporotic patient. Anatomic reduction is known to be necessary to give functional result to patient.However, it's technically difficult because of the pelvic bone conformation.

The presence of dome impaction makes the surgery more difficult. Per operatory scanner associated to 3D navigation is proved his value-added in spinal surgery.The aim of the study is show that this association permit a technical improvement for the surgeon in the precision of fracture reduction.and restore the articular congruence.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 31, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- age> 18

- surgery for acetabular fracture within 30 days

- with dome impaction

Exclusion Criteria:

- disability of inferior limb

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• use of O-arm surgical imaging
during acetabular fracture surgery , use of O-arm surgical imaging with

Locations
Country Name City State
France Groupe Hospitalier Paris Saint Joseph Paris Ile-de-France

Sponsors (1)
Lead Sponsor Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary dome impaction reduction measurement dome impaction reduction measurement on scanner per operatory and post operatory day1
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