Thoracic-Lumbar Arthrodesis- Implanet Jazz
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorFrancis Farhadi
About this trial
Establish a data repository of patients who have undergone single, two-, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female patients, 18 years of age and older
Qualified candidate for hybrid thoracolumbar fixation with the Implanet Jazz System TM during arthrodesis surgery.
Disqualifiers
Individuals who have not yet reached the age of 18.
Trial population
Adult men and women of any/all ethnic groups who are appropriate candidates for hybrid thoracolumbar fixation and will receive the Implanet Jazz System (TM) during their arthrodesis surgery.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Prospective follow-up of patients who have received instrumented lumbar arthrodesis supplemented the Implanet Jazz System(TM)
Other interventionTo assess the clinical outcomes of patients receiving standard of care Implanet Jazz System(TM) at the time of their instrumented lumbar arthrodesis.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
clinical prospective review- Prospective Database study for future studies
Collecting clinical measurements. Examples of these clinical measurements are the VAS Pain Scale, SF-36, NDI, and ODI.
Time frame
5- yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Francis Farhadi
Lead sponsor
University of Kentucky
Sponsor institution
Implanet America, Inc.
Collaborator
Source ClinicalTrials.gov