Spine Fusion for Degenerative Spine DiseaseQOARNCT03650855
Vertebral Bone Quality and Prediction of Screw Loosening in Spine Fusion
An observational study of Spine Fusion for Degenerative Spine Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Finding a way to use Vertebral CT scan will help to predict screw loosing risk in spinal fusion for degenerative spine disease. Patients who will undergo at least two spine fusion levels for degenerative spine disease will be enrolled in. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Fusion for Degenerative Spine Disease
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 25 Sep 2018to 25 Jun 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited by their surgeon during the current consultation 3 months before the surgery where the decision must support an arthrodesis of at least 2 levels between T3 and S1. The surgeon checks the inclusion criteria and offers the patient to participate. Inclusion will be done during this consultation. Patients will be informed by the surgeon of the nature of the study. They are intended to provide information to this effect and a certificate of non-opposition to the participation will be.
Who may be able to join
- More than 18 years old
- needed a minimum 2 levels spinal fusion
- agreed protocol
Who cannot join
- Cimented pedicular screws
- secondary surgery
- neurodegenerative disease
Trial locations and contacts
1 site in 1 country.
About this study
Finding a way to use Vertebral CT scan will help to predict screw loosing risk in spinal fusion for degenerative spine disease. Patients who will undergo at least two spine fusion levels for degenerative spine disease will be enrolled in. Before surgery, patients will undergo a spinal QCT scan with a calibrated phantom. The calibrated bone density, at bone-implant interface, will be assessed using dual energy CT scan immediately after surgery, and six months later. The primary outcomes will be the difference between the two values of the bone implant interface. The difference between density values will be correlated to the pre-op bone density value.
Read the detailed description
Screw loosening is a real problem in degenerative spine surgery because of the morbidity of secondary surgery sometimes needed for elderly patients. Today, there is no real possibility to know before surgery if cemented screws are needed or not. The use of cemented screws has its morbidity. In fact, bone densitometry is not a good exam to predict the bone quality in degenerative spine because of the arthritis. T-score in degenerative spine can be overestimated. The goal of our study is analyze the bone-implant interface after spine fusion using dual-energy CT scan technology which can provide pictures without artifact compared to standard CT scan. This is a prospective observational monocentric study. Patients over 18 years old and have undergone at least two primary spine fusion levels will be enrolled. The exclusion criteria are the use of cemented screws, secondary surgery and neurodegenerative disease. The primary outcome will be the change in the bone-implant interface at six months post-surgery compared to the interface after surgery. The change will be assessed by calibrated dual CT scan. The interface bone density will be assessed using calibrated scans, and correlate to the true vertebral bone density measured before surgery with a QCT. We hope that this study can provide a simple and reproducible help for surgeons to choose between uncommented and cemented screws for their spine fusions surgeries.
- Keywords
- degenerative spine disease, screw loosening, Quantitative CT scan, vertebral bone density
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of bone-implant interface at 6-month follow up compared to post operative interface assessed on Dual energy CT Scan
Assessment of bone-implant interface (1 to 3 mm around the screw) using calibrated bone density on spinal dual energy CT scan just after surgery and at 6 months of follow up. Comparison between the two measured values.
Measured: 6 montths
Secondary outcomes (1)
evolution of bone density of non instrumented levels between T0 and 6 months follow up assessed with Dual Energy CT scan
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start25 Sep 2018
- Primary completion25 Jun 2022
- Study completion25 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine Fusion for Degenerative Spine DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugues HM PASCAL-MOUSSELARD, PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650855
- Sponsor's protocol ID
- NI17046J
- Acronym
- QOAR
- Status last verified
- Mar 2022
- First submitted
- 27 Aug 2018
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vertebral Bone Quality and Prediction of Screw Loosening in Spine Fusion
- ClinicalTrials.gov ID
- NCT03650855
- Acronym / sponsor ID
- QOAR / NI17046J
- Keywords
- degenerative spine disease, screw loosening, Quantitative CT scan, vertebral bone density
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 25 Jun 2022 (actual)
- Study completion
- 25 Jun 2022 (actual)
- First posted
- 29 Aug 2018 (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.
Finding a way to use Vertebral CT scan will help to predict screw loosing risk in spinal fusion for degenerative spine disease. Patients who will undergo at least two spine fusion levels for degenerative spine disease will be enrolled in. Before surgery, patients will undergo a spinal QCT scan with a calibrated phantom. The calibrated bone density, at bone-implant interface, will be assessed using dual energy CT scan immediately after surgery, and six months later. The primary outcomes will be the difference between the two values of the bone implant interface. The difference between density values will be correlated to the pre-op bone density value.
Detailed description
Screw loosening is a real problem in degenerative spine surgery because of the morbidity of secondary surgery sometimes needed for elderly patients. Today, there is no real possibility to know before surgery if cemented screws are needed or not. The use of cemented screws has its morbidity. In fact, bone densitometry is not a good exam to predict the bone quality in degenerative spine because of the arthritis. T-score in degenerative spine can be overestimated. The goal of our study is analyze the bone-implant interface after spine fusion using dual-energy CT scan technology which can provide pictures without artifact compared to standard CT scan. This is a prospective observational monocentric study. Patients over 18 years old and have undergone at least two primary spine fusion levels will be enrolled. The exclusion criteria are the use of cemented screws, secondary surgery and neurodegenerative disease. The primary outcome will be the change in the bone-implant interface at six months post-surgery compared to the interface after surgery. The change will be assessed by calibrated dual CT scan. The interface bone density will be assessed using calibrated scans, and correlate to the true vertebral bone density measured before surgery with a QCT. We hope that this study can provide a simple and reproducible help for surgeons to choose between uncommented and cemented screws for their spine fusions surgeries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited by their surgeon during the current consultation 3 months before the surgery where the decision must support an arthrodesis of at least 2 levels between T3 and S1. The surgeon checks the inclusion criteria and offers the patient to participate. Inclusion will be done during this consultation. Patients will be informed by the surgeon of the nature of the study. They are intended to provide information to this effect and a certificate of non-opposition to the participation will be.
Key inclusion criteria (3 listed)
- More than 18 years old
- needed a minimum 2 levels spinal fusion
- agreed protocol
Key exclusion criteria (3 listed)
- Cimented pedicular screws
- secondary surgery
- neurodegenerative disease
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
Change of bone-implant interface at 6-month follow up compared to post operative interface assessed on Dual energy CT Scan
Time frame: 6 montths
Assessment of bone-implant interface (1 to 3 mm around the screw) using calibrated bone density on spinal dual energy CT scan just after surgery and at 6 months of follow up. Comparison between the two measured values.
1 secondary outcome
evolution of bone density of non instrumented levels between T0 and 6 months follow up assessed with Dual Energy CT scan
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Hugues HM PASCAL-MOUSSELARD, PH principal investigator
Assistance Publique - Hôpitaux de Paris
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 Spine Fusion for Degenerative Spine Disease, run by Assistance Publique - Hôpitaux de Paris 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 3 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: finished, as of the sponsor's last update on 13 Jan 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of bone-implant interface at 6-month follow up compared to post operative interface assessed on Dual energy CT Scan (time frame: 6 montths). 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 13 Jan 2023.