Titanium vs. PEEK Fusion Devices in 1 Level TLIF

Twin Cities Spine Center

Status and phase: Invitation-only; Phase 4

Conditions: Spine Fusion; Lumbar Spondylolisthesis; Lumbar Stenosis

Treatments: Device: Titanium Fusion Device; Device: PEEK Fusion Device

Study type: Interventional

Funder types: Other

Identifiers

NCT05691062

1944564

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

PEEK

Experimental group

Description:

Medtronic Capstone

Treatment:

Device: PEEK Fusion Device

Titanium

Experimental group

Description:

Medtronic Adaptix

Treatment:

Device: Titanium Fusion Device