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

NCT ID: NCT03817606

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2021-04-27

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 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.

Conditions

Degenerative Disc Disease; Degenerative Scoliosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tritanium Posterior Lumbar Cage

Surgical placement of the Tritanium Posterior Lumbar Cage

Group Type: EXPERIMENTAL

Tritanium Posterior Lumbar Cage

Intervention Type: DEVICE

Placement of Tritanium Posterior Lumbar Cage via TLIF procedure

AVS PEEK UniLIF

Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage

Group Type: ACTIVE_COMPARATOR

AVS UniLIF PEEK Posterior Lumbar Cage

Intervention Type: DEVICE

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

Interventions

Tritanium Posterior Lumbar Cage

Placement of Tritanium Posterior Lumbar Cage via TLIF procedure

Intervention Type: DEVICE

AVS UniLIF PEEK Posterior Lumbar Cage

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Spine

INDUSTRY

Sponsor Role: collaborator

Riverside Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Juan Jimenez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa Zipsie

Role: STUDY_DIRECTOR

Riverside Medical Center

Juan Jimenez, MD

Role: PRINCIPAL_INVESTIGATOR

Riverside Medical Center

Locations

Riverside Medical Center

Kankakee, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

RMC193

Identifier Type: -

Identifier Source: org_study_id