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A Prospective Non-concurrent Controlled Evaluation of Open and MAS® PLIF

NCT01640977 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 67

Last updated 2025-12-24

No results posted yet for this study

Summary

The study is a prospective non-concurrent controlled observational evaluation of short-term operative results. As such, study sites will capture perioperative (through 6-week postoperative follow-up) case data associated with 10 standard open PLIF (posterior lumbar interbody fusion) procedures. After this open experience, these same sites will capture the corresponding data from 10 subsequent cases where the MAS (Maximum Access Surgery) PLIF variant was performed. The data from both series of cases will be compiled to identify similarities and differences between the techniques.

Conditions

  • Lumbar Degenerative Disc Disease

Interventions

PROCEDURE

Open PLIF (posterior lumbar interbody fusion)

The PLIF procedure achieves access to the degenerated disc from the back of the spine.

PROCEDURE

MAS PLIF

The MAS PLIF technique is a minimally invasive variant of the traditional PLIF procedure. It is similarly performed through a single midline posterior incision but is conducted through a more medialized posterior approach.

Sponsors & Collaborators

  • NuVasive

    lead INDUSTRY

Principal Investigators

  • Kelli Howell, MS · NuVasive

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-06-30
Completion
2014-09-30

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 NCT01640977 on ClinicalTrials.gov