Vertebral Bone Quality and Prediction of Screw Loosening in Spine Fusion (QOAR)

• ClinicalTrials.gov Identifier: NCT03650855
• Recruitment Status: Recruiting
• First Posted: August 29, 2018
• Last Update Posted: November 12, 2020
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Study Description

Brief 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. 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.

Condition or disease
Spine Fusion for Degenerative Spine Disease

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

• Study Type: Observational
• Estimated Enrollment: 23 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Vertebral Bone Quality and Prediction of Screw Loosening in Spine Fusion
• Actual Study Start Date: September 25, 2018
• Estimated Primary Completion Date: June 25, 2022
• Estimated Study Completion Date: June 25, 2022

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

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

Contacts and Locations

Contacts

Contact: Hugues HM PASCAL-MOUSSELARD, PH; +336 42 17 70 51; hugues.mousselard@aphp.fr

Contact: Nessima NY YELLES; +33142167594; nessima.yelles@aphp.fr

Locations

France

Hôpital Pitié Salpêtrière; Recruiting

Paris, France, 75013

Contact: Scemama Caroline, MD PhD

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Hugues HM PASCAL-MOUSSELARD, PH; Assistance Publique - Hôpitaux de Paris

More Information

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT03650855
• Other Study ID Numbers: NI17046J
• First Posted: August 29, 2018
• Last Update Posted: November 12, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:

degenerative spine disease; screw loosening; Quantitative CT scan; vertebral bone density

Additional relevant MeSH terms:

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases