Status:
TERMINATED
A Comparison of Stryker's Tritanium Posterior Lumbar Cage and PEEK Implant
Lead Sponsor:
Riverside Medical Center
Collaborating Sponsors:
Stryker Spine
Conditions:
Degenerative Disc Disease
Degenerative Scoliosis
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
The purpose of this study is to compare outcomes of patients with degenerative disc disease undergo lumbar spinal fusion with Stryker's Tritanium® Posterior Lumbar Cage or the UniLIF PEEK implant.
Detailed Description
This study protocol intends to examine the difference in efficacy between the Tritanium Posterior Lumbar Cage and the UniLIF PEEK implant with respect to how long it takes to achieve fusion of the spi...
Eligibility Criteria
Inclusion
- Subject is skeletally mature
- Subject has one or more of the following diagnoses:
- Degenerative Disc Disease (DDD) at one level or two contiguous levels from L2 to S1
- a. DDD may include up to Grade 1 spondylolisthesis at the involved level(s)
- Degenerative Scoliosis for which the interbody fusion device will be used as an adjunct to fusion
- Subject has received 6 months of non-operative therapy
- Subject understands the conditions of enrollment and is willing to sign and date the Informed Consent
- Subject agrees to comply with visit schedule and study assessments
- Provision of signed and dated informed consent form
- Subject stated willingness to comply with all study procedures and availability for the duration of the study
- Subject is in good general health as evidenced by medical history
Exclusion
- Subject is obese (BMI \> 40)
- Subject is sensitive to titanium materials
- Subject has an active infection at the operative site
- Subject has marked local inflammation
- Subject has any abnormality present which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, bone absorption, osteopenia, tumors involving the spine, active infection at the site, or certain metabolic disorders affecting osteogenesis
- Subject has any mental, trauma, or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care
- Subject has any open wounds
- Subject is pregnant or plans to become pregnant during the course of the study
- Subject has inadequate tissue coverage over the operative site.
- Subject has an neuromuscular deficit which places an unsafe load on the device during the healing period
- Subject has any condition of senility, mental illness, or substance abuse
- Subject has any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors, congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood cell count (WBC), or marked left shift in the WBC differential count.
- Subject has prior fusion at the levels to be treated
- Subject is incarcerated
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2021
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03817606
Start Date
March 1 2019
End Date
April 27 2021
Last Update
January 10 2023
Active Locations (1)
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1
Riverside Medical Center
Kankakee, Illinois, United States, 60901