ARSN: Minimal Invasive TLIF Arthrodesis Using Augmented Reality Navigation for Percutaneous Pedicle Aiming

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Recruiting

CT.gov ID

NCT05077410

Collaborator

(none)

Enrollment

Location

16.8

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Surgery for degenerative spondylolisthesis requires decompression of the narrow lumbar canal and fixation by osteosynthesis-arthrodesis. Conventional surgery is done through the open route. For 10-15 years, minimally invasive techniques have been established, allowing faster postoperative recovery for the patient. The downside to these techniques is the use of intraoperative fluoroscopy. This is why surgical navigation systems have been developed, allowing safe positioning of implants (pedicle screws). A new process (augmented reality navigation) has been tested in vitro and applied in open surgery. The HUS were the first establishment to apply this new method in minimally invasive surgery in a hybrid room of surgery and interventional radiology.

Condition or Disease	Intervention/Treatment	Phase
Arthrosis

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Minimal Invasive TLIF Arthrodesis Using Augmented Reality Navigation for Percutaneous Pedicle Aiming

Actual Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Oct 25, 2021

Anticipated Study Completion Date :

Oct 25, 2021

Outcome Measures

Primary Outcome Measures

Retrospective description of minimally invasive surgery using augmented reality navigation [Files analysed retrospectively from March 01, 2019 to December 31, 2019 will be examined]]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion criteria:

Major subject (≥18 years old)
Subject operated at the HUS between March and December 2019
Subject with a surgical indication for arthrodesis and decompression of the lumbar canal for degenerative spondylolisthesis L3-L4 or L4-L5
Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion criteria:

Subject having expressed opposition to participating in the study
Subject under guardianship or guardianship
Subject under safeguard of justice

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service de Chirurgie du Rachis - Hôpitaux Universitaires de Strasbourg	Strasbourg		France	67091

Sponsors and Collaborators

University Hospital, Strasbourg, France

Investigators

Principal Investigator: Yann Philippe YannPhilippe.CHARLES@chru-strasbourg.fr, MD, PhD, Service de Chirurgie du Rachis - Hôpitaux Universitaires de Strasbourg