NCT01978847

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

5 years

First QC Date

October 24, 2013

Last Update Submit

September 18, 2019

Conditions

Spinal Condition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The number of patient with clinical evidences of fusions

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State Unviersity

Columbus, Ohio, 43210, United States

Location

Study Officials

  • Francis Farhadi, MDPHD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 24, 2013

First Posted

November 8, 2013

Study Start

May 1, 2013

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

September 19, 2019

Record last verified: 2019-09

Locations

US(1)