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

Arthrosis Clinical Trial

— ARSN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05077410
• Other study ID #: 7845
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: October 25, 2021

Study information

• Verified date: September 2021
• Source: University Hospital, Strasbourg, France
• Contact: Yann Philippe CHARLES, MD, PhD
• Phone: 33 3 68 76 52 68
• Email: YannPhilippe.CHARLES[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 25, 2021
• Est. primary completion date: October 25, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthrosis
• Joint Diseases
• Osteoarthritis

Locations

Country	Name	City	State
France	Service de Chirurgie du Rachis - Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retrospective description of minimally invasive surgery using augmented reality navigation		Files analysed retrospectively from March 01, 2019 to December 31, 2019 will be examined]