- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03650855
Vertebral Bone Quality and Prediction of Screw Loosening in Spine Fusion (QOAR)
January 12, 2023 updated by: Assistance Publique - Hôpitaux de Paris
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
28
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Paris, France, 75013
- Hopital Pitie Salpetriere
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- More than 18 years old
- needed a minimum 2 levels spinal fusion
- agreed protocol
Exclusion Criteria:
- Cimented pedicular screws
- secondary surgery
- neurodegenerative disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 montths
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hugues HM PASCAL-MOUSSELARD, PH, Assistance Publique - Hôpitaux de Paris
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 25, 2018
Primary Completion (Actual)
June 25, 2022
Study Completion (Actual)
June 25, 2022
Study Registration Dates
First Submitted
August 27, 2018
First Submitted That Met QC Criteria
August 28, 2018
First Posted (Actual)
August 29, 2018
Study Record Updates
Last Update Posted (Estimate)
January 13, 2023
Last Update Submitted That Met QC Criteria
January 12, 2023
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NI17046J
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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