Clinical Trials Directory

Trials / Terminated

TerminatedNCT04839783

Single Position Spine Surgery Registry

Multi-center, Prospective, Single Position, Spine Surgery Outcomes Registry

Status
Terminated
Phase
Study type
Observational
Enrollment
234 (actual)
Sponsor
Spine and Scoliosis Research Associates · Academic / Other
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to systematically, prospectively compare surgical fusion techniques for thoracolumbar spinal fusion patients and assess long-term patient outcomes and revision rates following surgery.

Detailed description

The goal of this study is to understand how the difference in positioning of a patient intraoperatively, as part of performing an anterior posterior spine fusion surgery, can affect short term and long term outcomes. This will be accomplished through observational techniques that will not affect the care patients will receive for their spinal conditions. Patients will be asked to complete health and wellness surveys before and after survey to determine how they are doing before surgery and then what if any changes their respective surgeries have had on their lives. Further spine x-rays that they have taken to plan their surgeries and assess their recovery will be measured, when available. X-rays will not be taken only for research purposes. Additionally aspects of their surgeries will be noted such as where hardware is placed and how long different parts of the surgery took. Follow-up is planned to be out to 10 years post-operatively with the goal of collecting information about any revision spine surgeries that would happen during those 10 years as well.

Conditions

Timeline

Start date
2020-07-07
Primary completion
2025-07-07
Completion
2025-07-07
First posted
2021-04-09
Last updated
2025-10-20

Locations

6 sites across 2 countries: United States, Australia

Source: ClinicalTrials.gov record NCT04839783. Inclusion in this directory is not an endorsement.