Lumbar Fusion With Porous Versus Non-Porous Cages

NCT05583864 | Active Not Recruiting FDA Device

• 1 other identifier: 77018
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this single site, randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo lumbar interbody fusion procedures (TLIF), supplemented with pedicle screw instrumentation, using one of the following interventions:

1. 1.Porous titanium cages
2. 2.Non-porous titanium-coated poly-ether-ether-ketone (PEEK) cages.

Conditions

Arthrodesis; Spinal Fusion; Lumbar Fusion; Spondylolisthesis; Pseudarthrosis

Keywords

Spinal Cage; PEEK; Pseudarthrosis; Spondylolisthesis; Titanium; Fusion; Transforaminal; Interbody; Posterolateral; CONDUIT; PROTI 360; TLIF

Outcome Measures

Primary Outcomes (1)

• Brantigan-Steffee-Frasier (BSF) Fusion Scale

  Graded radiographic evaluation of ossification and/or pseudarthrosis between vertebrae. The evaluation applies a three-level scale of fusion success: BSF-1: Radiographical pseudarthrosis BSF-2: Radiographical locked pseudarthrosis BSF-3: Radiographical fusion Radiographic Success: Radiographic success is defined by radiographical fusion (BSF-3) presenting bone bridges within at least half of the fusion area with at least the density originally achieved at surgery. Radiographic Failure: Radiographic failure is defined by radiographical pseudarthrosis (BSF-1 or -2)

  Six months following procedure

Secondary Outcomes (3)

• Oswestry Disability Index (ODIv2.1a)

  Preoperative, three, six, twelve, and twenty-four month follow-ups.

• Neurological Pain Scale for Back and Legs

  Preoperative, three, six, twelve, and twenty-four month follow-ups.

• PROMIS-10 Global

  Preoperative, three, six, twelve, and twenty-four month follow-ups.

Study Arms (2)

CONDUIT Porous Titanium Spinal Cage

ACTIVE COMPARATOR

Solid titanium spinal cage, infused with microscopic, porous canals to allow for adhesion and proliferation of bone graft factors contributing to spinal ossification, and ultimately, spinal fusion between vertebrae demonstrating instability.

Device: CONDUIT Porous Titanium Spinal Cage

PROTI 360 Titanium-Coated PEEK Spinal Cage

ACTIVE COMPARATOR

Spinal cage composed primarily of a medical-grade polymer: poly-ether-ether-ketone (PEEK), with a titanium coating that is etched, but lacking porous features. These design features also attempt to stimulate spinal vertebrae fusion through bone-graft ossification and enhance vertebral stability.

Device: PROTI 360 Titanium-Coated PEEK Spinal Cage

Interventions

CONDUIT Porous Titanium Spinal Cage DEVICE

Already included in arm/group descriptions.

Also known as: DePuy Synthes CONDUIT™

CONDUIT Porous Titanium Spinal Cage

PROTI 360 Titanium-Coated PEEK Spinal Cage DEVICE

Already included in arm/group descriptions.

Also known as: DePuy Synthes PROTI 360º™

PROTI 360 Titanium-Coated PEEK Spinal Cage

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• They are scheduled to undergo combined interbody and posterolateral spinal fusion surgery using either the DePuy Synthes CONDUIT™ porous titanium cage or the DePuy Synthes PROTI 360º™ non-porous titanium-coated PEEK cage in conjunction with local autograft 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 physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.

You may not qualify if:

• 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, bone absorption, or osteoporosis.
• Subject has a condition requiring medications that may interfere with bone or soft tissue 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 opinion of the investigator, would preclude participation in the study.
• Subject is currently involved in another investigational drug or device study that could 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 with protocol assessments and/or with the subject's ability to complete the protocol required follow-up.
• Subjects who are pregnant or plan to become pregnant in the next 12 months or who are lactating. This restriction is due to the inherent risk radiography presents to an embryo or fetus and is considered standard of care.
• Subject is involved in or planning to engage in litigation or receiving Worker's Compensation related to neck or back pain. Participation may effect the assessments made by case workers and legal teams.
• Subject is a prisoner.

Sponsors & Collaborators

• Francis Farhadi: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Ankylosis; Spondylolisthesis; Pseudarthrosis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Fractures, Ununited; Fractures, Bone; Wounds and Injuries

Study Officials

• Francis Farhadi, MD, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

• Craig van Horne, MD, PhD

  University of Kentucky

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Neurosurgery

Model Details: Two types of spinal cages will be evaluated against one another for patient outcomes. It is possible that a single patient may receive both cages, but outcomes will be radiographically assessed individually by cage.

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 18, 2022
• Study Start: November 1, 2022
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)