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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Degenerative Disc Disease, Degenerative Scoliosis

Intervention / Treatment
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* Device: Tritanium Posterior Lumbar Cage
* Device: AVS UniLIF PEEK Posterior Lumbar Cage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tritanium Posterior Lumbar Cage<br>Surgical placement of the Tritanium Posterior Lumbar Cage | Device: Tritanium Posterior Lumbar Cage<br>* Placement of Tritanium Posterior Lumbar Cage via TLIF procedure<br>|
| Active Comparator: AVS PEEK UniLIF<br>Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage | Device: AVS UniLIF PEEK Posterior Lumbar Cage<br>* Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.<br>|

What is the study measuring?
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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 |