Skip to main content
OpenTrials
Completed

NCT Number: NCT03650855

Vertebral Bone Quality and Prediction of Screw Loosening in Spine Fusion

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spine Fusion for Degenerative Spine Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Pitié Salpêtrière

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: QOAR

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 29, 2018
Registry last updated
Jan 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.