ArthrosisARSNNCT05077410
Minimal Invasive TLIF Arthrodesis Using Augmented Reality Navigation for Percutaneous Pedicle Aiming
An observational study of Arthrosis, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthrosis
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2020to 25 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Major subject with a surgical indication for arthrodesis and decompression of the lumbar canal for degenerative spondylolisthesis L3-L4 or L4-L5
Who may be able to join
- 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.
Who cannot join
- Subject having expressed opposition to participating in the study
- Subject under guardianship or guardianship
- Subject under safeguard of justice
Trial locations and contacts
1 site in 1 country.
Saïd CHAYER, PhD, HDR contact
France1 site, 1 recruiting
- Recruiting
Service de Chirurgie du Rachis - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Yann Philippe CHARLES, MD, PhD, 33 3 68 76 52 68, YannPhilippe.CHARLES@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, said.chayer@chru-strasbourg.fr
About this study
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.
- Conditions
- Arthrosis
- Keywords
- Arthrosis, Spondylolisthesis, Degenerative spondylolisthesis, Arthrodesis, Osteosynthesis-arthrodesis, Fluoroscopy., Pedicle screws
- Medical subject headings
- Osteoarthritis, Spondylolisthesis, Ankylosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective description of minimally invasive surgery using augmented reality navigation
Measured: Files analysed retrospectively from March 01, 2019 to December 31, 2019 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start1 Jun 2020
- Primary completion25 Oct 2021 (estimated)
- Study completion25 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yann Philippe YannPhilippe.CHARLES@chru-strasbourg.fr, MD, PhD, Principal investigator, Service de Chirurgie du Rachis - Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077410
- Sponsor's protocol ID
- 7845
- Acronym
- ARSN
- Status last verified
- Sep 2021
- First submitted
- 30 Sep 2021
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Invasive TLIF Arthrodesis Using Augmented Reality Navigation for Percutaneous Pedicle Aiming
- ClinicalTrials.gov ID
- NCT05077410
- Acronym / sponsor ID
- ARSN / 7845
- Conditions
- Arthrosis
- Keywords
- Arthrosis, Spondylolisthesis, Degenerative spondylolisthesis, Arthrodesis, Osteosynthesis-arthrodesis, Fluoroscopy., Pedicle screws
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 25 Oct 2021 (estimated)
- Study completion
- 25 Oct 2021 (estimated)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major subject with a surgical indication for arthrodesis and decompression of the lumbar canal for degenerative spondylolisthesis L3-L4 or L4-L5
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Subject having expressed opposition to participating in the study
- Subject under guardianship or guardianship
- Subject under safeguard of justice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective description of minimally invasive surgery using augmented reality navigation
Time frame: Files analysed retrospectively from March 01, 2019 to December 31, 2019 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saïd CHAYER, PhD, HDR contact
Yann Philippe YannPhilippe.CHARLES@chru-strasbourg.fr, MD, PhD principal investigator
Service de Chirurgie du Rachis - Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthrosis, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yann Philippe CHARLES, MD, PhD (33 3 68 76 52 68, YannPhilippe.CHARLES@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective description of minimally invasive surgery using augmented reality navigation (time frame: Files analysed retrospectively from March 01, 2019 to December 31, 2019 will be examined]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.