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

NCT03018392 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-09-07

Study results available
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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

  • Intervertebral Disc Disease

Interventions

DEVICE

Stryker Tritanium Spinal System

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

Sponsors & Collaborators

  • Bone and Joint Clinic of Baton Rouge

    lead OTHER

Principal Investigators

  • Chambliss Harrod, MD · Bone and Joint Clinic of Baton Rouge

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2020-01-28
Completion
2020-01-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03018392 on ClinicalTrials.gov