NCT03434223

Brief Summary

Establish a data repository of patients who have undergone single, two-, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

December 29, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2019

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

2.4 years

First QC Date

February 9, 2018

Last Update Submit

September 7, 2021

Conditions

SpondylolisthesisSpinal StenosisDegenerative Disease

Outcome Measures

Primary Outcomes (1)

  • Number of patients who have undergone lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System

    60 months

Study Arms (1)

Single Cohort

Eligibility Criteria

Age60 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are candidates for single, two- or three-level spinal arthrodesis surgery supplemented by the Implanet Jazz System

You may qualify if:

  • Patients who are candidates for single, two- or three-level spinal arthrodesis surgery supplemented by the Implanet Jazz System
  • Patients at least 60 years of age.

You may not qualify if:

  • Patients under the age of 60 years old are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

SpondylolisthesisSpinal Stenosis

Condition Hierarchy (Ancestors)

SpondylolysisSpondylosisSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • H. Francis Farhadi, MD, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
60 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 9, 2018

First Posted

February 15, 2018

Study Start

December 29, 2016

Primary Completion

June 6, 2019

Study Completion

June 6, 2019

Last Updated

September 10, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)