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

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Condition

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State Unviersity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Spinal arthrodesis can be performed through either anterior, posterior, or lateral approaches for a variety of traumatic, degenerative, or deformity conditions.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• NA

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of patients with radiologic evidence of fusion	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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of patient with clinical evidences of fusions	examples of clinical measurement are Pain Scores and the Visual Analog Scale	5 years

Collaborators and Investigators

• Sponsor: H Francis Farhadi, MD, PhD
• Investigators: Principal Investigator: Francis Farhadi, MDPHD, Ohio State University

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: October 24, 2013
• First Submitted That Met QC Criteria: November 1, 2013
• First Posted (Estimate): November 8, 2013

Study Record Updates

• Last Update Posted (Actual): September 19, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2013H0153