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

Lumbar Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01640977
• Other study ID #: NUVA.P1001
• Status: Completed
• Phase: N/A
• First received: July 9, 2012
• Last updated: April 29, 2015
• Start date: June 2012
• Est. completion date: September 2014

Study information

• Verified date: April 2015
• Source: NuVasive
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Lumbar Degenerative Disc Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Kuether Brain and Spine	Greensboro	North Carolina
United States	Nova Neurosurgical Brain and Spine	Greensboro	North Carolina
United States	Scott and White Healthcare	Temple	Texas
United States	WellSpan Orthopedics-York	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
NuVasive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Clinical Outcomes	Visual analog scale (for patient self assessment of back/leg pain)	6-weeks	No
Secondary	Radiographic Outcomes	Radiographic assessment (AP/lateral x-rays)	6-weeks	No

External Links

•   sponsor website