Clinical trial NCT03817606: A Comparison of Stryker's Tritanium Posterior Lumbar Cage and PEEK Implant
Official title: A Comparison of Stryker's Tritanium Posterior Lumbar Cage and PEEK Implant on Spinal Fusion in Patients With Degenerative Disc Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Degenerative Disc Disease
Degenerative Scoliosis
Lead sponsor: Riverside Medical Center
Sponsor class: OTHER
Collaborators: name: Stryker Spine
First posted: 2019-01-25
Enrollment: 4
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel randomized controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Fusion Success
timeFrame: 12 Months
Secondary outcomes:
measure: Change in Visual Analogue Scale
timeFrame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
measure: Change in Low Back Function
timeFrame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
measure: Change in Quality of Life: SF-36 PCS
timeFrame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation.
measure: Number of Participants That Return to Work
timeFrame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
measure: Ambulatory Status
timeFrame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
measure: Number of Participants With Serious Adverse Events
timeFrame: 6 weeks; 3 months; 6 months; and 12 months post operation
measure: Change in Quality of Life: EQ-5d
timeFrame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Other outcomes:
Locations:
city: Kankakee
country: United States
facility: Riverside Medical Center
state: Illinois
Study officials:
affiliation: Riverside Medical Center
name: Lisa Zipsie
role: STUDY_DIRECTOR
affiliation: Riverside Medical Center
name: Juan Jimenez, MD
role: PRINCIPAL_INVESTIGATOR
References: