A Prospective Data Collection Study of Patients Treated with a Single-Level Lumbar Interbody Fusion Stabilized with Pedicle Screws
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Lumbar Spine Degeneration
- Sponsor
- 3Spine
- Enrollment
- 176
- Locations
- 20
- Primary Endpoint
- Serious device-related adverse events (SDAE)
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
This study is designed to collect real world evidence (RWE) safety and efficacy data on patients who plan to undergo a single-level Transforaminal lumbar interbody fusion (TLIF) or Posterior lumbar interbody fusion (PLIF) instrumented with pedicle screws, using the framework of a prospective clinical study (with defined enrollment criteria and pre-specified research follow-up timepoints).
Detailed Description
A prospective, multi-center (up to 25), non-blinded study of patients who plan to undergo a single-level Transforaminal lumbar interbody fusion (TLIF) or Posterior lumbar interbody fusion (PLIF) stabilized with pedicle screws. Investigators will only select those patients who are planned for treatment with on-label use of FDA cleared TLIF/PLIF devices (cage and screw system). At least 200 subjects with a potential sample size re-estimation at completion. The subjects will return for follow-up at 6-weeks, 3-months, 6-months, and then annually for 5-years post surgery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female, age 21-80 (inclusive) with at least 3 years of life expectancy;
- •Subject plans to undergo a one-level Open or Mini-Open TLIF or PLIF procedure (stabilized with pedicle screws) independent of this research protocol;
- •Subject is to be treated with on-label use of an FDA-cleared TLIF or PLIF cage(s) and pedicle screw system independent of this research protocol;
- •The subject has a primary diagnosis of symptomatic lumbar degeneration with or without foraminal or recess stenosis of the lumbar spine at a single level from L1/L2 to L5/S1 confirmed by subject history and radiographic imaging (CT, MRI, X-rays) with no more than a Grade 1 (\<25% translation) spondylolisthesis. Symptomatic lumbar degeneration that may be associated with a co-morbid condition such as:
- •Herniated nucleus pulposus;
- •Scarring/thickening of the ligamentum flavum, annulus fibrosus, or facet joint capsule;
- •Facet joint degeneration/osteophyte formation;
- •Spondylosis (defined by the presence of osteophytes);
- •Disc degeneration and/or annular degeneration; and/or
- •Lumbar stenosis defined by spinal cord or nerve root compression;
Exclusion Criteria
- •More than one vertebral level requiring treatment;
- •Previous instrumented surgery (i.e.: anterior disc replacement, spinal fusion, interspinous device, etc.) at the index lumbar level or an adjacent level;
- •Degenerative or lytic spondylolisthesis greater than Grade 1 (\<25% translation);
- •Rotatory scoliosis at the level to be treated;
- •Congenital bony and/or spinal cord abnormalities at the level to be treated;
- •Subcaudal defect, disrupting the integrity of the pedicle;
- •Clinically compromised vertebral bodies at the involved level due to current or past trauma, e.g., by the radiographic appearance of the fracture callus, malunion or nonunion;
- •Disrupted anterior longitudinal ligament at the index level;
- •Overlying thoracolumbar kyphosis (greater than or equal to 15 degrees) within one level (includes target and adjacent level) of the level to be treated;
- •Back pain of unknown etiology without leg pain;
Outcomes
Primary Outcomes
Serious device-related adverse events (SDAE)
Time Frame: 24 months
Subject success will be determined with the absence of any serious device-related adverse events (SDAE)
Oswestry Disability Index (ODI) Score
Time Frame: 24 months compared to baseline
Improvement of at least 15 points in ODI score (out of 100). The ODI is a self-reported questionnaire that contains ten sections concerning intensity of pain, lifting, personal care, walking, sitting, sexual function, standing, social life, sleeping and traveling.
Secondary surgical intervention (SSI)
Time Frame: 24 months
Subject success will be determined with the absence of a secondary surgical intervention including revision, re-operation, removal, or supplemental fixation at the index level.
Neurological Status
Time Frame: 24 months compared to baseline
Absence of deterioration in neurological status compared to baseline examinations. Neurological examination will consist of a motor and sensory examination at each in person study visit conducted per physician standard of care.
Secondary Outcomes
- VAS(24 months compared to baseline)
- VAS - Back(24 months compared to baseline)
- Visual Analog Score (VAS) - Worst Leg(24 months compared to baseline)
- ODI(24 months compared to baseline)