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

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03817606
• Other study ID #: RMC193
• Status: Terminated
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: April 27, 2021

Study information

• Verified date: December 2022
• Source: Riverside Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: April 27, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Degenerative Scoliosis
• Intervertebral Disc Degeneration
• Scoliosis

Intervention

Device:
• Tritanium Posterior Lumbar Cage
Placement of Tritanium Posterior Lumbar Cage via TLIF procedure
• AVS UniLIF PEEK Posterior Lumbar Cage
Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.

Locations

Country	Name	City	State
United States	Riverside Medical Center	Kankakee	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Riverside Medical Center	Stryker Spine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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