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Spinal Fusion

Examination Group for Lumbar Spine Degeneration (3STLIF Trial)

N/A
Recruiting
Research Sponsored by 3Spine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

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).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Neurological Status
Oswestry Disability Index (ODI) Score
Secondary surgical intervention (SSI)
+1 more
Secondary study objectives
ODI
VAS
VAS - Back
+1 more
Other study objectives
Demographics
Intra-Operative Variables
PROMIS scores (Anxiety)
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Examination GroupExperimental Treatment1 Intervention
There will only be one arm of subjects in this study. The arm will include subjects who plan to undergo a single-level TLIF/PLIF stabilized with pedicle screws and meet all of the eligibility criteria.

Find a Location

Who is running the clinical trial?

MCRAIndustry Sponsor
35 Previous Clinical Trials
9,530 Total Patients Enrolled
MCRA, LLCIndustry Sponsor
18 Previous Clinical Trials
7,340 Total Patients Enrolled
3SpineLead Sponsor
1 Previous Clinical Trials
158 Total Patients Enrolled
1 Trials studying Lumbar Spine Degeneration
158 Patients Enrolled for Lumbar Spine Degeneration
~47 spots leftby Sep 2025
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