Minimal Invasive TLIF Arthrodesis Using Augmented Reality Navigation for Percutaneous Pedicle Aiming
ARSN
1 other identifier
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
September 30, 2021
CompletedFirst Posted
Study publicly available on registry
October 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2021
CompletedOctober 14, 2021
September 1, 2021
1.4 years
September 30, 2021
September 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Major subject with a surgical indication for arthrodesis and decompression of the lumbar canal for degenerative spondylolisthesis L3-L4 or L4-L5
You may qualify if:
- 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.
You may not qualify if:
- Subject having expressed opposition to participating in the study
- Subject under guardianship or guardianship
- Subject under safeguard of justice
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service de Chirurgie du Rachis - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yann Philippe YannPhilippe.CHARLES@chru-strasbourg.fr, MD, PhD
Service de Chirurgie du Rachis - Hôpitaux Universitaires de Strasbourg
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2021
First Posted
October 14, 2021
Study Start
June 1, 2020
Primary Completion
October 25, 2021
Study Completion
October 25, 2021
Last Updated
October 14, 2021
Record last verified: 2021-09