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OpenTrials
Completed

NCT Number: NCT01978847

Retrospective Review of Anterior and Posterior Cervical, Thoracic, and Lumbar Instrumented Arthrodesis Surgeries

Retrospective review will allow for an evaluation of potential patient- or procedure-related factors that are associated with the development of either radiologic or clinical adjacent-segment pathology.

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Key information

Conditions

Spinal Condition

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State Unviersity

Columbus, Ohio, 43210, United States

About this study

Spinal arthrodesis can be performed through either anterior, posterior, or lateral approaches for a variety of traumatic, degenerative, or deformity conditions. In recent years, the development of more sophisticated segmental instrumentation techniques and hardware has allowed for incorporation of multiple spinal levels in single settings. The long-term consequences for spinal motion segments adjacent to such fusions remain unknown.

The investigators propose to undertake a retrospective case study analysis evaluating both radiologic and clinical parameters indicative of adjacent-segment pathology in patients who have undergone instrumented arthrodesis procedures at Ohio State University, performed by either Dr. Francis Farhadi, James B. Elder, or Gary Rea.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must have had a Spinal arthrodesis procedure at Ohio State University

Exclusion criteria

  • NA

Treatment and study plan

Primary outcomes

  1. The number of patients with radiologic evidence of fusion

    Time frame: 5 years

    Radiologic review will include X-Rays, CT, and MRI at pre-surgery, as well as X-rays at 6 weeks, 3, 6, 12, 24, 36, 48 and 60 months post-operatively.

Secondary outcomes

  1. The number of patient with clinical evidences of fusions

    Time frame: 5 years

    examples of clinical measurement are Pain Scores and the Visual Analog Scale

Sponsors and collaborators

Lead sponsor

H Francis Farhadi, MD, PhD

Other

Registry information

Official study title

Proposal for Retrospective Review of Anterior&Posterior Cervical, Thoracic, and Lumbar Instrumented Arthrodesis Surgeries Performed at OSU.

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Nov 8, 2013
Registry last updated
Sep 19, 2019

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.

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