A Comparison of Stryker's Tritanium Posterior Lumbar Cage and PEEK Implant

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 21 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Subject is skeletally mature - Subject has one or more of the following diagnoses: 1.
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) 2. 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 Criteria:

    - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03817606
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Riverside Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Lisa Zipsie
Principal Investigator Affiliation Riverside Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherIndustry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Degenerative Disc Disease, Degenerative Scoliosis
Additional Details

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 spine. Study participants will undergo a transforaminal lumbar interbody fusion (TLIF) surgery and return for CT and x-ray follow-up to measure the degree to which fusion has been achieved. Survey methodology to assess perceived pain, level of disability, and quality of life will also be used to measure the differences between groups on these components.

Arms & Interventions

Arms

Experimental: Tritanium Posterior Lumbar Cage

Surgical placement of the Tritanium Posterior Lumbar Cage

Active Comparator: AVS PEEK UniLIF

Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage

Interventions

Device: - Tritanium Posterior Lumbar Cage

Placement of Tritanium Posterior Lumbar Cage via TLIF procedure

Device: - AVS UniLIF PEEK Posterior Lumbar Cage

Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Riverside Medical Center, Kankakee, Illinois

Status

Recruiting

Address

Riverside Medical Center

Kankakee, Illinois, 60901

Site Contact

Joseph Hanks

[email protected]

815-935-7256 #6151