Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Implanet Jazz SystemTMd

Terminated

• Conditions: Spondylolisthesis; Proximal Joint Kyphosis (PJK); Spinal Stenosis

• Registration Number: NCT02411799
• Lead Sponsor: Ohio State University

Brief Summary

Establish a data repository of patients who have undergone thoracic and/or lumbar instrumented arthrodesis procedure supplemented by the Implanet Jazz System.

Detailed Description

The purpose of this study is to create a data repository of patients who have undergone spinal arthrodesis procedures supplemented with the Implanet Jazz System. 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 bony fusion.

Patients who are candidates for hybrid thoracolumbar fixation with the Implanet Jazz System during arthrodesis surgery will be asked to participate in this protocol. Clinical data will be collected as indicated at 6 weeks, as well as 3, 6, 12, 24, 36 48, and 60 months post surgery in the database. Data collected will include demographic and surgical information, physiological data, neurological assessments and patient reported outcomes. This comprehensive database will allow for gathering of relevant information for potential future research use.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-03
• Study First Submitted QC: 2015-04-07
• Study First Posted: 2015-04-08
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-09
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• Patients who are candidates for spinal arthrodesis surgery (thoracic and/or lumbar) supplemented by the Implanet Jazz System are eligible to participate in this study.

Exclusion Criteria

• Patients under the age of 18 are excluded because the investigators do not routinely perform spinal arthrodesis surgery on these patients.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients who have undergone thoracic and/or lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System.	60 months

Trial Locations

Locations (1)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States