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

NCT03817606 | Terminated Results FDA Device

• 1 other identifier: RMC193
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Disc Disease; Degenerative Scoliosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in Visual Analogue Scale

  Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation

• Change in Low Back Function

  Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation

• Change in Quality of Life: SF-36 PCS

  Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation.

• Number of Participants That Return to Work

  Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation

• Ambulatory Status

  Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation

Study Arms (2)

Tritanium Posterior Lumbar Cage

EXPERIMENTAL

Surgical placement of the Tritanium Posterior Lumbar Cage

Device: Tritanium Posterior Lumbar Cage

AVS PEEK UniLIF

ACTIVE COMPARATOR

Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage

Device: AVS UniLIF PEEK Posterior Lumbar Cage

Interventions

Tritanium Posterior Lumbar Cage DEVICE

Placement of Tritanium Posterior Lumbar Cage via TLIF procedure

Tritanium Posterior Lumbar Cage

AVS UniLIF PEEK Posterior Lumbar Cage DEVICE

Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.

AVS PEEK UniLIF

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riverside Medical Center: lead
• Stryker Spine: collaborator

Study Sites (1)

Riverside Medical Center

Kankakee, Illinois, 60901, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Cynthia Koehn, Clinical Research Nurse
• Organization: Riverside Medical Center

ckoehn@rhc.net

815-933-1671

Study Officials

• Lisa Zipsie

  Riverside Medical Center

  STUDY DIRECTOR

• Juan Jimenez, MD

  Riverside Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Study participants will not know which posterior lumbar cage they receive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel randomized controlled trial

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: January 25, 2019
• Study Start: March 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: April 27, 2021
• Last Updated: January 10, 2023
• Results First Posted: December 15, 2021

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)