Retrospective Review of Anterior and Posterior Cervical,... | NCT01978847

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

NCT01978847

Sponsor

H Francis Farhadi, MD, PhD

Status

Completed

Last Update Posted

Sep 19, 2019Actual

Enrollment

500Actual

Phase

Not provided

Conditions

Spinal Condition

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

May 1, 2018Actual

Completion Date

May 1, 2018Actual

First Submitted Date

Oct 24, 2013

First Submission Date that Met QC Criteria

Nov 1, 2013

First Posted Date

Nov 8, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2019

Last Update Posted Date

Sep 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Actual

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must have had a Spinal arthrodesis procedure at Ohio State University

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Francis Farhadi, MDPHD	Ohio State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Ohio State Unviersity		Columbus	Ohio	43210	United States