Titanium vs. PEEK Fusion Devices in 1 Level TLIF

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Twin Cities Spine Center
Study ID
NCT05691062
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Lumbar Spondylolisthesis
  • Lumbar Stenosis
  • Spine Fusion

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Titanium Fusion Device — DEVICE
    Titanium fusion device will be utilized for one-level lumbar fusion.
  • PEEK Fusion Device — DEVICE
    PEEK fusion device will be utilized for one-level lumbar fusion.

Study Details

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.

Key Dates

Start date
Sep 1, 2024
Status verified
Jun 2025
Primary completion
Jan 11, 2027
Completion
Jan 11, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PEEK
    Medtronic Capstone
  • Experimental: Titanium
    Medtronic Adaptix

Primary Outcome Measure

Fusion Status of 1 level Lumbar TLIF [ Time Frame: 12 months Post-Op ]

Locations (1)

FacilityCityStateZIPSite coordinators
Twin Cities Spine CenterMinneapolisMinnesota55404-

Find similar trials in Minneapolis, MN

By research site
Twin Cities Spine Center· Minneapolis, MN

Related Studies