Titanium vs. PEEK Fusion Devices in 1 Level TLIF

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2028-01-11

Brief Summary

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The objective of this study is to evaluate and follow the clinical and radiographic outcomes of patients undergoing 1 level TLIF randomized to either a titanium or a PEEK spacer to 24 months after surgery.

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Detailed Description

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Transforaminal lumbar interbody fusion (TLIF) remains a common surgical technique for the management of lumbar spondylosis requiring decompression and fusion. The choice of interbody spacer remains dependent on surgeon preference with a variety of options available for use. Two of the most commonly used interbody spacers are made of polyetheretherketone (PEEK) and titanium.1 While both spacers have produced reliable rates of fusion with good clinical outcomes, debate remains as to which interbody spacer is superior. Proponents of PEEK argue that it is radiolucent and has an elastic modulus similar to bone thus decreasing rates of subsidence. However, PEEK is a hydrophobic material that does not integrate with bone. Titanium on the other hand demonstrates osseointegration and may lead to increased rates of fusion.While there are retrospective studies available comparing the two materials, the studies are small and there is a paucity of prospective data comparing the radiographic and clinical outcomes of these spacers. Given the frequency with which these spacers are used, it is important to determine which spacer produces better clinical and radiographic outcomes for patients.

Conditions

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Spine Fusion Lumbar Spondylolisthesis Lumbar Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized clinical trial with two cohorts.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Subjects will be blinded to fusion device.

Study Groups

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PEEK

Medtronic Capstone

Group Type EXPERIMENTAL

PEEK Fusion Device

Intervention Type DEVICE

PEEK fusion device will be utilized for one-level lumbar fusion.

Titanium

Medtronic Adaptix

Group Type EXPERIMENTAL

Titanium Fusion Device

Intervention Type DEVICE

Titanium fusion device will be utilized for one-level lumbar fusion.

Interventions

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Titanium Fusion Device

Titanium fusion device will be utilized for one-level lumbar fusion.

Intervention Type DEVICE

PEEK Fusion Device

PEEK fusion device will be utilized for one-level lumbar fusion.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients undergoing 1 level TLIF for the treatment of lumbar stenosis and spondylolisthesis who have failed at least 6 weeks of non-operative treatment.
2. Patients between 18-70 years of age at the time of surgery.

Exclusion Criteria

1. Patients under 18 or over 70 years of age at the time of surgery.
2. Patients undergoing more than 1 level of surgery.
3. Patients who have had prior lumbar fusion.
4. Patients requiring surgery for the management of infection, tumor, or trauma.
5. Patients who are pregnant.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No