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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03817606
Recruitment Status : Recruiting
First Posted : January 25, 2019
Last Update Posted : June 10, 2019
Sponsor:
Collaborator:
Stryker Spine
Information provided by (Responsible Party):
Juan Jimenez, Riverside Medical Center

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.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Degenerative Scoliosis Device: Tritanium Posterior Lumbar Cage Device: AVS UniLIF PEEK Posterior Lumbar Cage Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel randomized controlled trial
Masking: Single (Participant)
Masking Description: Study participants will not know which posterior lumbar cage they receive.
Primary Purpose: Treatment
Official Title: A Comparison of Stryker's Tritanium Posterior Lumbar Cage and PEEK Implant on Spinal Fusion in Patients With Degenerative Disc Disease
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Number of Participants with Fusion Success [ Time Frame: 12 Months ]
    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


Secondary Outcome Measures :
  1. Change in Visual Analogue Scale [ Time Frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation ]
    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.

  2. Change in Low Back Function [ Time Frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation ]
    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).

  3. Change in Quality of Life: SF-36 PCS [ Time Frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation. ]
    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).

  4. Number of Participants that return to Work [ Time Frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation ]
    Subjects who were unable to work due to their back pain who return to work.

  5. Ambulatory Status [ Time Frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation ]
    Amount of time to full ambulation without assistance for study participants who had no or partial ambulation at baseline.

  6. Number of Participants with Serious Adverse Events [ Time Frame: 6 weeks; 3 months; 6 months; and 12 months post operation ]
    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

  7. Change in Quality of Life: EQ-5d [ Time Frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation ]
    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.



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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817606


Contacts
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Contact: Joseph Hanks 815-935-7256 ext 6151 jhanks@RHC.net
Contact: Juan Jimenez, MD (815) 932-7200 jjimenez@RHC.net

Locations
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United States, Illinois
Riverside Medical Center Recruiting
Kankakee, Illinois, United States, 60901
Contact: Joseph Hanks    815-935-7256 ext 6151    jhanks@RHC.net   
Contact: Juan Jimenez    815-932-7200    jjimenez@RHC.net   
Principal Investigator: Juan Jimenez, MD         
Sponsors and Collaborators
Riverside Medical Center
Stryker Spine
Investigators
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Study Director: Lisa Zipsie Riverside Medical Center
  Study Documents (Full-Text)

Documents provided by Juan Jimenez, Riverside Medical Center:
Study Protocol  [PDF] September 21, 2018
Informed Consent Form  [PDF] October 8, 2018

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Responsible Party: Juan Jimenez, Principal Investigator, Riverside Medical Center
ClinicalTrials.gov Identifier: NCT03817606    
Other Study ID Numbers: RMC193
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Scoliosis
Intervertebral Disc Degeneration
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases