Clinical Trials Directory

Trials / Completed

CompletedNCT03018392

Clinical and Radiological Evaluation of Patients With DDD Following TLIF With 3-D Printed Titanium Cage

Fusion Rate and Clinical Outcomes Following 1 or 2 Level Open Transforaminal Lumbar Interbody Fusion for Degenerative Disc Disease With Novel 3-D Printed Titanium Cages With Pedicle Screw Fixation

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Bone and Joint Clinic of Baton Rouge · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to evaluate the fusion rate and clinical outcomes at 1 year of 20 patients with degenerative disc disease who undergo a Transforaminal Lumbar Interbody Fusion (TLIF) with the Stryker Tritanium Spinal System. This is an on-label, post-market outcomes study to build on the body of long-term evidence for the device.

Conditions

Interventions

TypeNameDescription
DEVICEStryker Tritanium Spinal Systemopen transforaminal lumbar interbody fusion (TLIF) utilizing the Stryker Tritanium cages with pedicle screw fixation according to instructions for use and package labeling for on-label indications

Timeline

Start date
2017-01-01
Primary completion
2020-01-28
Completion
2020-01-28
First posted
2017-01-12
Last updated
2022-09-07
Results posted
2022-09-07

Source: ClinicalTrials.gov record NCT03018392. Inclusion in this directory is not an endorsement.