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

A Comparison of Stryker's Tritanium Posterior Lumbar Cage and PEEK Implant on Spinal Fusion in Patients With Degenerative Disc Disease

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.

Study Overview

• Status: Terminated
• Conditions: Degenerative Disc Disease; Degenerative Scoliosis
• Intervention / Treatment: Device: Tritanium Posterior Lumbar Cage; Device: AVS UniLIF PEEK Posterior Lumbar Cage

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Kankakee, Illinois, United States, 60901
      • Riverside Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tritanium Posterior Lumbar Cage; Surgical placement of the Tritanium Posterior Lumbar Cage	Device: Tritanium Posterior Lumbar Cage; Placement of Tritanium Posterior Lumbar Cage via TLIF procedure
Active Comparator: AVS PEEK UniLIF; Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage	Device: AVS UniLIF PEEK Posterior Lumbar Cage; Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Fusion Success	CT and X-ray imaging will be obtained at study visits and Fusion Success will be defined by the following criteria: no lucent area around the implant; no presences of herniated disk, central stenosis, lateral recess stenosis, foraminal stenosis, facet anthropathy; no fracture of the device, graft or vertebra; visible bone formation in or about the graft material; less than 3 degrees of inter-segmental position change on flexion and extension views; presence of subsidence: a migration of more than 3mm into the adjacent vertebra; and the proportion of bridging bone visually estimated over the surface area of the joint	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Analogue Scale	Change in low back pain as indicated by Visual Analogue Scale (VAS). The VAS measures subjects' self-reported pain level on a 100 mm line on which the subject indicates their level of pain, where 0 is no pain and 100 is worst imaginable pain.	Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Change in Low Back Function	Change in Oswestry Disability Index (ODI) score. The ODI assesses disability related to lower back pain using a Likert 0 to 5 scale. There are 10 sections to the assessment, and the scores are represented as a percentage ranging from 0 (no disability) to 100 (completely disabled).	Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Change in Quality of Life: SF-36 PCS	Change in perception of quality of life, as measured by Short Form 36 Health Survey (SF-36 PCS). The SF-36 PCS is a 36-item patient reported health questionnaire to measure perceived quality of life across 8 domains. Higher scores indicate higher quality of life, and lower scores indicate lower quality of life. Scores range from 5 (poor physical function) to 80 (excellent clinical function).	Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation.
Number of Participants That Return to Work	Subjects who were unable to work due to their back pain who return to work.	Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Ambulatory Status	Amount of time to full ambulation without assistance for study participants who had no or partial ambulation at baseline.	Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Number of Participants With Serious Adverse Events	Any event meeting the Serious Adverse Event reporting criteria detailed in the study protocol occurring at the following time intervals: TLIF procedure, hospital recovery and discharge, and 6 weeks-, 3 months-, 6 months- and 12 months post operation	6 weeks; 3 months; 6 months; and 12 months post operation
Change in Quality of Life: EQ-5d	Change in perception of quality of life, as measured by the EuroQol-5d (EQ-5d). The EuroQol-5d is a five question broad quality of life measure that can be combined into a single index and represents current health. A score of 0.0 is the worst imaginable health while a score of 1.0 would be the best imaginable health.	Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation

Collaborators and Investigators

• Sponsor: Riverside Medical Center
• Collaborators: Stryker Spine
• Investigators: Study Director: Lisa Zipsie, Riverside Medical Center; Principal Investigator: Juan Jimenez, MD, Riverside Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): April 27, 2021

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: January 21, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis; Intervertebral Disc Degeneration
• Other Study ID Numbers: RMC193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes