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Post-market Surveillance Study of FLXfit™ TLIF Interbody Fusion Device

NCT02805985 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-01-25

No results posted yet for this study

Summary

This study is a post-market clinical follow-up study. A post-market, prospective clinical trial will be conducted. The data collected from this study will serve the purpose of confirming safety and performance of the FLXfit™ implant.

Conditions

  • Degenerative Disc Disease
  • Spondylolisthesis
  • Retrolisthesis

Interventions

DEVICE

FLXfit™ TLIF Interbody Fusion Device

The FLXfit™ is an expandable, articulated interbody fusion device (IBFD) used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy.

Sponsors & Collaborators

  • Rush University Medical Center

    collaborator OTHER

  • Expanding Orthopedics Ltd.

    lead INDUSTRY

Principal Investigators

  • Dustin H Massel, BS · Rush University Medical Center

  • Benjamin C Mayo, BA · Rush University Medical Center

  • Fady Hijji, BS · Rush University Medical Center

  • Kern Singh, MD · Rush University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-06-30
Completion
2018-06-30

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 NCT02805985 on ClinicalTrials.gov