Thoracic-Lumbar Arthrodesis- Implanet Jazz

• Sponsor: H. Francis Farhadi (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05366140
• Collaborator: Implanet America, Inc. (Other)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 120
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spondylolisthesis; Spinal Stenosis; Degenerative Disease	Other: Prospective follow-up of patients who have received instrumented lumbar arthrodesis supplemented the Implanet Jazz System(TM)

Detailed Description

To collect and organize data into a repository from the Principal Investigator's and other Site Investigators' patients who are undergoing single, two-level, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz SystemTM at participating centers. This device is designed to provide a stable interface between spinal constructs and the rods; it can be secured around vertebral structures (such as the lamina, transverse or spinous processes) from T1 to L5 and is intended to provide temporary stabilization as a bone anchor during the development of a solid body fusion. Of note, these patients will receive the supplemental support of the Implanet Jazz Sublaminar Band as their clinical standard of care deems necessary and separately from study participation.

Clinical data will be collected as indicated at 6 weeks, as well as 3, 6, 12, 24, 36, 48, and 60 months post-operatively in the database.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Follow-up of Patients Undergoing Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Implanet Jazz System TM.
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Sep 1, 2025
• Anticipated Study Completion Date: Sep 1, 2032

Outcome Measures

Primary Outcome Measures

1. clinical prospective review- Prospective Database study for future studies [5- years]

   Collecting clinical measurements. Examples of these clinical measurements are the VAS Pain Scale, SF-36, NDI, and ODI.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Individuals who have not yet reached the age of 18.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kentucky	Lexington	Kentucky	United States	40536

Sponsors and Collaborators

• H. Francis Farhadi
• Implanet America, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: H. Francis Farhadi, Associate Professor, University of Kentucky
• ClinicalTrials.gov Identifier: NCT05366140
• Other Study ID Numbers: 73811
• First Posted: May 9, 2022
• Last Update Posted: Jun 29, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by H. Francis Farhadi, Associate Professor, University of Kentucky: Thoracic-Lumbar Arthrodesis; Spinal fusion; back pain
• Additional relevant MeSH terms: Spinal Stenosis; Spondylolisthesis

Study Results

No Results Posted as of Jun 29, 2022