CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Stryker Tritanium Spinal Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03018392
NCT03018392N/ACompleted
CompareCT.gov

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

Bone and Joint Clinic of Baton Rouge·interventional·Posted Jan 12, 2017·Updated Sep 7, 2022

In Brief

A clinical study evaluating Stryker Tritanium Spinal System for Intervertebral Disc Disease. Completed, enrolled 20 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIntervertebral Disc Disease
Countries--
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 12, 2017
Enrollment StartJan 1, 2017
Primary CompletionJan 28, 2020
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 9.5 years ago

Interventions

Stryker Tritanium Spinal Systemdevice

open 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