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

Not Applicable

Terminated

Conditions: Degenerative Disc Disease
Degenerative Scoliosis

Interventions: Device: AVS UniLIF PEEK Posterior Lumbar Cage
Device: Tritanium Posterior Lumbar Cage

Registration Number: NCT03817606

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 4

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AVS PEEK UniLIF	AVS UniLIF PEEK Posterior Lumbar Cage	Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage
Tritanium Posterior Lumbar Cage	Tritanium Posterior Lumbar Cage	Surgical placement of the Tritanium Posterior Lumbar Cage

Primary Outcome Measures

Name	Time	Method
Number of Participants With Fusion Success	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

Name	Time	Method
Change in Low Back Function	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).
Change in Quality of Life: EQ-5d	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.
Change in Visual Analogue Scale	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.
Ambulatory Status	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.
Change in Quality of Life: SF-36 PCS	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).
Number of Participants That Return to Work	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.
Number of Participants With Serious Adverse Events	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