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

Primary Purpose

Degenerative Disc Disease, Degenerative Scoliosis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tritanium Posterior Lumbar Cage
AVS UniLIF PEEK Posterior Lumbar Cage
Sponsored by
Riverside Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Riverside Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tritanium Posterior Lumbar Cage

AVS PEEK UniLIF

Arm Description

Surgical placement of the Tritanium Posterior Lumbar Cage

Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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).
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).
Number of Participants That Return to Work
Subjects who were unable to work due to their back pain who return to work.
Ambulatory Status
Amount of time to full ambulation without assistance for study participants who had no or partial ambulation at baseline.
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
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.

Full Information

First Posted
December 20, 2018
Last Updated
December 15, 2022
Sponsor
Riverside Medical Center
Collaborators
Stryker Spine
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1. Study Identification

Unique Protocol Identification Number
NCT03817606
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to COVID-19 disruption
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
April 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Riverside Medical Center
Collaborators
Stryker Spine

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease, Degenerative Scoliosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel randomized controlled trial
Masking
Participant
Masking Description
Study participants will not know which posterior lumbar cage they receive.
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tritanium Posterior Lumbar Cage
Arm Type
Experimental
Arm Description
Surgical placement of the Tritanium Posterior Lumbar Cage
Arm Title
AVS PEEK UniLIF
Arm Type
Active Comparator
Arm Description
Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage
Intervention Type
Device
Intervention Name(s)
Tritanium Posterior Lumbar Cage
Intervention Description
Placement of Tritanium Posterior Lumbar Cage via TLIF procedure
Intervention Type
Device
Intervention Name(s)
AVS UniLIF PEEK Posterior Lumbar Cage
Intervention Description
Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.
Primary Outcome Measure Information:
Title
Number of Participants With Fusion Success
Description
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
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Change in Visual Analogue Scale
Description
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.
Time Frame
Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Title
Change in Low Back Function
Description
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).
Time Frame
Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Title
Change in Quality of Life: SF-36 PCS
Description
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).
Time Frame
Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation.
Title
Number of Participants That Return to Work
Description
Subjects who were unable to work due to their back pain who return to work.
Time Frame
Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Title
Ambulatory Status
Description
Amount of time to full ambulation without assistance for study participants who had no or partial ambulation at baseline.
Time Frame
Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Title
Number of Participants With Serious Adverse Events
Description
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
Time Frame
6 weeks; 3 months; 6 months; and 12 months post operation
Title
Change in Quality of Life: EQ-5d
Description
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.
Time Frame
Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is skeletally mature Subject has one or more of the following diagnoses: 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) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Zipsie
Organizational Affiliation
Riverside Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Juan Jimenez, MD
Organizational Affiliation
Riverside Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riverside Medical Center
City
Kankakee
State/Province
Illinois
ZIP/Postal Code
60901
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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