NCT04823858

3Spine Lumbar Fusion Real World Evidence Study

A Prospective Data Collection Study of Patients Treated With a Single-Level Lumbar Interbody Fusion Stabilized With Pedicle Screws

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 176 (actual)
• Sponsor: 3Spine · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to collect real world evidence (RWE) safety and efficacy data on patients who plan to undergo a single-level Transforaminal lumbar interbody fusion (TLIF) or Posterior lumbar interbody fusion (PLIF) instrumented with pedicle screws, using the framework of a prospective clinical study (with defined enrollment criteria and pre-specified research follow-up timepoints).

Detailed description

A prospective, multi-center (up to 25), non-blinded study of patients who plan to undergo a single-level Transforaminal lumbar interbody fusion (TLIF) or Posterior lumbar interbody fusion (PLIF) stabilized with pedicle screws. Investigators will only select those patients who are planned for treatment with on-label use of FDA cleared TLIF/PLIF devices (cage and screw system). At least 200 subjects with a potential sample size re-estimation at completion. The subjects will return for follow-up at 6-weeks, 3-months, 6-months, and then annually for 5-years post surgery.

Conditions

• Lumbar Spine Degeneration

Interventions

Type	Name	Description
PROCEDURE	Lumbar Interbody Fusion	The TLIF/PLIF system includes a TLIF/PLIF interbody cage and a pedicle screw system (4 screws with 2 rods). Any FDA cleared TLIF/PLIF interbody cage and pedicle screw system is acceptable for this study (with the exception of PEEK rods) as long as it is implanted per the package insert. No subjects implanted with an off-label use of a device are permitted for this study.

Timeline

• Start date: 2021-05-25
• Primary completion: 2026-11-15
• Completion: 2029-11-15
• First posted: 2021-04-01
• Last updated: 2025-03-26

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated device study