Clinical trial NCT03012776: A Pivotal Study of the Premia Spine TOPS™ System
Official title: A Clinical Study to Assess the Safety and Effectiveness of the Premia Spine TOPS™ System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spinal Stenosis
Degenerative Spondylolisthesis
Lead sponsor: Premia Spine
Sponsor class: INDUSTRY
First posted: 2017-01-06
Enrollment: 305
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to assess whether the Total Posterior Spine System (TOPS System) is more effective than transforaminal lumbar interbody fusion (TLIF) when used to stabilize a single lumbar level (L2 - L5) following surgical decompression in patients diagnosed with (1) at least moderate lumbar spinal stenosis, and (2) Grade 1 spondylolisthesis (or retrolisthesis), and (3) thickening of the ligamentum flavum or scarring of the facet joint capsule.

Success will be assessed by means of a composite endpoint that measures improvement in in patient reported outcomes and the absence of any major device related complications.

Detailed description: Degenerative spine disease is a normal part of the aging process and can cause pain and significantly limit normal movement. The most commonly diagnosed condition is Lumbar Spinal Stenosis (LSS) which presents with pain, and often weakness or numbness in the buttocks and/or lower extremities that is worsened with standing and walking. For patients that do not respond to conservative treatment decompressive surgery is indicated. When LSS is accompanied by a diagnosis of degenerative spondylolisthesis, fusion of the affected segment is often added to prevent progression of the instability that may accompany the removal of bony elements as part of the decompression. While decompression and fusion have been shown to significantly improve patient outcomes, when compared to decompression alone, fusion has been associated with several comorbidities such as adjacent level degeneration and pseudoarthrosis.

The TOPS System was designed as an alternative to fusion and is a motion preserving posterior spine implant designed to provide dynamic stabilization to a single lumbar spine segment following decompression surgery.

Patients meeting all of the entry criteria will be randomized (2:1) to receive either the TOPS System or TLIF following decompression surgery. Patients will be followed for 5 years and the composite primary endpoint will be assessed at 2 years following index surgery.

Eligibility criteria: Inclusion Criteria:

* Be between 35 and 80 years of age;
* Must demonstrate at a single level to be treated (L2/3, L3/4 or L4/5) all three of the following;

  1. Degenerative spondylolisthesis or retrolisthesis up to Grade I, as determined by the investigator based on flexion/extension X-rays,
  2. At least moderate lumbar spinal stenosis, defined as at least a 25% reduction in either the central canal, the lateral recess space, and/or the foramen when compared to an adjacent level, as determined by the investigator based on MRI,
  3. Thickening of the ligamentum flavum and/or scarring of the facet joint capsule as identified by the investigator based on MRI.
* Have had at least six (6) months of failed conservative treatment prior to surgery (e.g., physical therapy, use of anti-inflammatory medications at maximum recommended dosage; administration of epidural/facet injections and/or nerve block);
* Have an Oswestry Disability Index (ODI) score of at least 40/100 at baseline;
* Have leg pain with a VAS score of at least 40/100 for at least one leg at baseline ;
* Lower back pain with a VAS score of at least 10 points less than Worst Leg VAS score;
* Neurogenic claudication (as defined by worsening leg pain when walking or standing, which is reduced when sitting or bending forward);

Exclusion Criteria:

* Presence of free fragment disc herniation at the index level or either adjacent level;
* Less than 4mm of disc height at the index level;
* Spondylolisthesis greater than Grade I;
* Back or non-radicular leg pain of unknown etiology;
* Stenosis caused by an extruded spinal disc fragment (e.g., herniation) or where the etiology is considered to be congenital, iatrogenic, post-traumatic, or metabolic;
* Known allergy or sensitivity to PEEK, titanium, cobalt chrome, and/or polyurethane;
* Prior surgery at any lumbar vertebral level with instrumentation;
* Prior surgery at the index or adjacent lumbar vertebral level;
* Clinically compromised vertebral bodies at the affected level;
* Scoliosis greater than ten (10) degrees by major Cobb angle;
* BMI \> 40;
* Osteoporosis;
* Paget's disease, gout, osteomalacia, osteogenesis imperfecta, thyroid and/or parathyroid gland disorder and/or other metabolic bone disease;
* Active infection - systemic or local;
* Active hepatitis;
* AIDS, HIV, Rheumatoid arthritis or other autoimmune disease;
* Tuberculosis - active or in the past 3 years;
* Active malignancy;
* Any medical condition requiring treatment with any drug known to potentially interfere with bone/soft tissue healing or receiving radiation therapy that is expected to continue for the duration of the study;
* Cauda equina syndrome or neurogenic bowel/bladder dysfunction;
* Vascular claudication due to severe arterial insufficiency of the legs;
* Sustained pathologic lumbar fractures of the vertebra or multiple lumbar fractures of the vertebra or hip;
* Significant peripheral neuropathy causing decreased sensation in a stocking-like or non-radicular and non-dermatomal distribution in the lower extremities;
* Insulin-dependent diabetes mellitus;
* Immunologically suppressed, receiving steroids \> 1 month out of the past year;
* Current chemical/alcohol dependency;
* Current smoker or user of tobacco products;
* Pregnant or interested in becoming pregnant;
* Currently involved in active spinal litigation;
* Currently having a workman's compensation claim;
* Currently incarcerated;

Primary outcomes:
measure: Improvement in Oswestry Disability Index (ODI)
timeFrame: 24 months
measure: Maintenance or improvement in Neurological status as assessed by a standard neurological exam performed by Investigator
timeFrame: 24 months
measure: No epidural steroid injection, facet joint injection, nerve block, or placement of spinal cord stimulator
timeFrame: 24 months
measure: No subsequent surgical intervention
timeFrame: 24 months
measure: Radiographic confirmation of fusion in control arm and non-fusion in the TOPS arm
timeFrame: 24 months
measure: Absence of any major device related adverse event
timeFrame: 24 months
Secondary outcomes:
measure: Greater range-of-motion through flexion-extension
timeFrame: 24 months
measure: Improvement (20 mm) in visual analogue scale (VAS) for back pain and worst leg
timeFrame: 24 months
measure: Reduction in physical component score on SF-12
timeFrame: 24 months
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Adventist Health Glendale
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai
state: California
city: Orange
country: United States
facility: University of California - Irvine Medical Center
state: California
city: Palm Desert
country: United States
facility: Eisenhower Desert Orthopedic Center
state: California
city: San Francisco
country: United States
facility: St. Mary's Medical Center, Spine Center
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Boulder
country: United States
facility: Boulder Neurosurgical & Spine Associates
state: Colorado
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Washington
country: United States
facility: Sibley Hospital/Johns Hopkins
state: District of Columbia
city: Clearwater
country: United States
facility: Florida Spine Institute
state: Florida
city: Jacksonville
country: United States
facility: St. Vincent's Spine & Brain Institute
state: Florida
city: Naples
country: United States
facility: Physicians Regional Medical Center
state: Florida
city: Sarasota
country: United States
facility: Kennedy White Orthopedic Center
state: Florida
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Carmel
country: United States
facility: Goodman Campbell Brain & Spine
state: Indiana
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Kalamazoo
country: United States
facility: Bronson Neuroscience Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Charlotte
country: United States
facility: Carolina Neurosurgery & Spine Associates, P.A.
state: North Carolina
city: Cincinnati
country: United States
facility: Univ. of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Medford
country: United States
facility: Southern Oregon Orthopedics
state: Oregon
city: Harrisburg
country: United States
facility: Orthopedic Institute of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: UPENN Health Systems Department of Neurosurgery
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
city: Bellaire
country: United States
facility: Orthopaedic Associates
state: Texas
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White
state: Texas
city: Richmond
country: United States
facility: Neurosurgical Associates, P.C.
state: Virginia
city: Huntington
country: United States
facility: Marshall University
state: West Virginia
city: Milwaukee
country: United States
facility: Wisconsin Bone and Joint S.C.
state: Wisconsin
Study officials:
References: