Phase
Condition
Spondylolisthesis
Spine Athroplasty
Ankylosing Spondylitis
Treatment
CONDUIT Porous Titanium Spinal Cage
PROTI 360 Titanium-Coated PEEK Spinal Cage
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients will be considered for inclusion if:
They are scheduled to undergo combined interbody and posterolateral spinal fusionsurgery using either the DePuy Synthes CONDUIT™ porous titanium cage or the DePuySynthes PROTI 360º™ non-porous titanium-coated PEEK cage in conjunction with localautograft bone, and supplementation with a pedicle screw system.
They are over the age of 18 years old.
They have been unresponsive to conservative care for a minimum of 6 months.
They are in the investigator's opinion, be psychosocially, mentally, and physicallyable to fully comply with this protocol including the required follow-up visits, thefilling out of required forms, and have the ability to understand and give writteninformed consent.
Exclusion
Exclusion Criteria:
Certain comorbidities and medical statuses may render patients ineligible for surgery, or put them at an increased risk for complications or injury by participating in the study. Therefore, patients will be excluded from enrollment if:
They have had previous lumbar arthrodesis surgery.
They require additional bone grafting materials other than local autograft bone.
There is inadequate tissue coverage over the operative site.
There is an open wound local to the operative area, or rapid joint disease, boneabsorption, or osteoporosis.
Subject has a condition requiring medications that may interfere with bone or softtissue healing(i.e., oral or parenteral glucocorticoids, immunosuppressives,methotrexate, etc.).
Subject has an active local or systemic infection.
Subject has a metal sensitivity/foreign body sensitivity (cages will be implanted).
Subject is morbidly obese, defined as a body mass index (BMI) greater than 40.
Subject has any medical condition or extenuating circumstance that, in the opinionof the investigator, would preclude participation in the study.
Subject is currently involved in another investigational drug or device study thatcould confound study data.
There is a history (present or past) of substance abuse (recreational drugs,prescription drugs or alcohol) that in the investigator's opinion may interfere withprotocol assessments and/or with the subject's ability to complete the protocolrequired follow-up.
Subjects who are pregnant or plan to become pregnant in the next 12 months or whoare lactating. This restriction is due to the inherent risk radiography presents toan embryo or fetus and is considered standard of care.
Subject is involved in or planning to engage in litigation or receiving Worker'sCompensation related to neck or back pain. Participation may effect the assessmentsmade by case workers and legal teams.
Subject is a prisoner.
Study Design
Study Description
Connect with a study center
University of Kentucky
Lexington, Kentucky 40536
United StatesActive - Recruiting
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