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Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Implanet Jazz SystemTMd

Prospective Multi-Center Follow-up of Patients Undergoing Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Implanet Jazz SystemTM

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02411799
Enrollment
154
Registered
2015-04-08
Start date
2015-04-30
Completion date
2021-06-30
Last updated
2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal Joint Kyphosis (PJK), Spinal Stenosis, Spondylolisthesis

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.

Interventions

None listed

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026