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

• Sponsor: Groupe Hospitalier Paris Saint Joseph (Other)
• Overall Status: Completed
• CT.gov ID: NCT03478189
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Actual Duration (Months): 27.7
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acetabular Fracture; Acetabular Surgery	Procedure: use of O-arm surgical imaging

Study Design

• Study Type: Observational
• Actual Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Added Value of Intraoperative CT Scanner and Screw Navigation in Operative Treatment of Displaced Acetabular Fracture With Dome Impaction
• Actual Study Start Date: Sep 8, 2017
• Actual Primary Completion Date: Dec 31, 2018
• Actual Study Completion Date: Dec 31, 2019

Outcome Measures

Primary Outcome Measures

1. dome impaction reduction measurement [day1]

   dome impaction reduction measurement on scanner per operatory and post operatory

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• age> 18

• surgery for acetabular fracture within 30 days

• with dome impaction

Exclusion Criteria:

• disability of inferior limb

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France	France	75014

Sponsors and Collaborators

• Groupe Hospitalier Paris Saint Joseph

Investigators

• Principal Investigator: Guillaume RIOUALLON, MD, Groupe Hospitalier Paris Saint Joseph

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Groupe Hospitalier Paris Saint Joseph
• ClinicalTrials.gov Identifier: NCT03478189
• Other Study ID Numbers: OARM impactionTOIT
• First Posted: Mar 27, 2018
• Last Update Posted: Feb 5, 2020
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fractures, Bone

Study Results

No Results Posted as of Feb 5, 2020