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FLXfit Post Market Outcome Study Protocol

NCT02882243 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2022-07-27

No results posted yet for this study

Summary

This investigation will provide safety and effectiveness information on the use of the FLXfit™ Cage. Data will be used for Post Market follow-up of the FLXfit™ system by evaluating:

* Safety as measured by the rate of serious operative and post-operative complications.
* Patients' quality of life, measured by health-related quality of life questionnaires up to 24 months following the procedure, as compared to patient's baseline.

Conditions

  • Degenerative Disc Disease Lumbar

Interventions

DEVICE

FLXfit Cage for fusion

Evaluating patient outcomes and radiographic outcomes

Sponsors & Collaborators

  • CoreLink, LLC

    collaborator UNKNOWN

  • Foundation for Orthopaedic Research and Education

    lead OTHER

Eligibility

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

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2022-01-31
Completion
2022-07-31

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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 NCT02882243 on ClinicalTrials.gov