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

A Prospective Non-current Concurrent Controlled Evaluation of Open and MAS® PLIF for the Treatment of Symptomatic Lumbar Degenerative Conditions

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Degenerative Disc Disease
• Intervention / Treatment: Procedure: Open PLIF (posterior lumbar interbody fusion); Procedure: MAS PLIF

Detailed Description

The objective of this evaluation is to collect and compare short-term factors related to the morbidity of approach using traditional posterior-approach interbody fusion techniques and a less invasive exposure for the same procedure. Perioperative measures and early outcomes will be documented to demonstrate differences in procedural requirements, safety, and early recovery. A total of 100 subjects will be consecutively enrolled in this prospective study from as many as 8 centers. Patients who, in the surgeon investigator's opinion, require instrumented lumbar interbody fusion and have consented to PLIF surgery for their conditions will be included. The following eligibility criteria are designed to identify existing clinic patients for whom study under this protocol is considered appropriate. All subjects must meet the inclusion/exclusion criteria in order to be considered for enrollment.

• Study Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • Kuether Brain and Spine
    • Greensboro, North Carolina, United States, 27401
      • Nova Neurosurgical Brain and Spine
  • Pennsylvania
    • York, Pennsylvania, United States, 17405
      • WellSpan Orthopedics-York
  • Texas
    • Temple, Texas, United States, 76508
      • Scott and White Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Existing clinic patients

Description

Inclusion Criteria:

• Subjects must meet all inclusion criteria to be eligible for enrollment into this observational study:

  1. Indicated for posterior lumbar interbody fusion at one or two contiguous motion segments between L1 and S1;
  2. 18+ years of age at the date of written informed consent;
  3. Able to undergo surgery based on physical exam, medical history and surgeon judgment;
  4. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol;

  5. Signed and dated informed consent form.

     Exclusion Criteria:

• Subjects presenting with any of the following will not be included in this observational study:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); The PLIF procedure achieves access to the degenerated disc from the back of the spine.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcomes	Visual analog scale (for patient self assessment of back/leg pain)	6-weeks
Radiographic Outcomes	Radiographic assessment (AP/lateral x-rays)	6-weeks

Collaborators and Investigators

• Sponsor: NuVasive
• Investigators: Study Director: Kelli Howell, MS, NuVasive

Publications and helpful links

Helpful Links

• sponsor website

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: July 9, 2012
• First Submitted That Met QC Criteria: July 11, 2012
• First Posted (Estimate): July 16, 2012

Study Record Updates

• Last Update Posted (Estimate): April 30, 2015
• Last Update Submitted That Met QC Criteria: April 29, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Lumbar spine; Open PLIF; MAS PLIF
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: NUVA.P1001