Vertebral Bone Quality and Prediction of Screw Loosening in Spine Fusion

NCT03650855 | Completed

• 1 other identifier: NI17046J
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Spine Fusion for Degenerative Spine Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• More than 18 years old
• needed a minimum 2 levels spinal fusion
• agreed protocol

You may not qualify if:

• Cimented pedicular screws
• secondary surgery
• neurodegenerative disease

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Pitié Salpêtrière

Paris, 75013, France

Location

Study Officials

• Hugues HM PASCAL-MOUSSELARD, PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: August 29, 2018
• Study Start: September 25, 2018
• Primary Completion: June 25, 2022
• Study Completion: June 25, 2022
• Last Updated: January 13, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)