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3Spine Lumbar Fusion Real World Evidence Study

NCT04823858 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 176

Last updated 2026-05-18

No results posted yet for this study

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).

Conditions

  • Lumbar Spine Degeneration

Interventions

DEVICE

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.

Sponsors & Collaborators

  • MCRA

    collaborator INDUSTRY

  • 3Spine

    lead INDUSTRY

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-25
Primary Completion
2025-12-23
Completion
2029-11-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04823858 on ClinicalTrials.gov