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

NCT01640977 | Completed

• 1 other identifier: NUVA.P1001
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Open PLIF; MAS PLIF; Lumbar spine

Outcome Measures

Primary Outcomes (1)

• Complications

  All complications will be compiled and their incidence and relationship to the product and/or surgical procedure will be tabulated for comparison.

  6-weeks

Secondary Outcomes (2)

• Clinical Outcomes

  6-weeks

• Radiographic Outcomes

  6-weeks

Study Arms (2)

Open PLIF

The PLIF procedure achieves access to the degenerated disc from the back of the spine, and is performed through a single midline posterior incision that is typically expanded bilaterally past the facet joints to expose bony landmarks for pedicle screw fixation, which are traditionally placed in a trajectory from lateral to medial, requiring a more lateral starting point.

Procedure: Open PLIF (posterior lumbar interbody fusion)

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, avoiding the far lateral exposure typical of the traditional PLIF.

Procedure: MAS PLIF

Interventions

Open PLIF (posterior lumbar interbody fusion) PROCEDURE

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

Open PLIF

MAS PLIF PROCEDURE

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.

MAS PLIF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Existing clinic patients

You may qualify if:

• Indicated for posterior lumbar interbody fusion at one or two contiguous motion segments between L1 and S1;
• + years of age at the date of written informed consent;
• Able to undergo surgery based on physical exam, medical history and surgeon judgment;
• Willing and able to return for post-treatment exams according to the follow-up called for in the protocol;
• Signed and dated informed consent form.

You may not qualify if:

• Subjects presenting with any of the following will not be included in this observational study:
• Mental or physical condition that would limit the ability to comply with study requirements;
• Spine abnormality requiring treatment at more than two levels;
• Prior surgery at operative or adjacent level(s);
• Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested);
• Significant general illness (e.g., HIV, active metastatic cancer of any type, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease);
• Participating in another clinical study that would confound study data.

Sponsors & Collaborators

• NuVasive: lead

Study Sites (4)

Kuether Brain and Spine

Greensboro, North Carolina, 27401, United States

Location

Nova Neurosurgical Brain and Spine

Greensboro, North Carolina, 27401, United States

Location

WellSpan Orthopedics-York

York, Pennsylvania, 17405, United States

Location

Scott and White Healthcare

Temple, Texas, 76508, United States

Location

Related Links

• sponsor website

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Kelli Howell, MS

  NuVasive

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2012
• First Posted: July 16, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (4)