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Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04823858
Study type Observational [Patient Registry]
Source 3Spine
Contact Kevin McGinnis
Phone 781-291-8040
Email kevin.mcginnis@3spine.com
Status Recruiting
Phase
Start date May 25, 2021
Completion date August 1, 2026

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