A Pivotal Study of the Premia Spine TOPS™ System

Lumbar Spinal Stenosis Clinical Trial

Official title:

A Clinical Study to Assess the Safety and Effectiveness of the Premia Spine TOPS™ System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03012776
• Other study ID #: CL-2830 - US IDE
• Status: Completed
• Phase: N/A
• Start date: July 17, 2017
• Est. completion date: June 14, 2023

Study information

• Verified date: June 2024
• Source: Premia Spine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: June 14, 2023
• Est. primary completion date: June 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Degenerative Spondylolisthesis
• Lumbar Spinal Stenosis
• Spinal Stenosis
• Spondylolisthesis

Intervention

Device:
• Total Posterior Spine System (TOPS)
Placement of TOPS System to provide posterior stabilization following decompression to treat lumbar spinal stenosis and spondylolisthesis

Procedure:
• Transforaminal Lumbar Interbody Fusion (TLIF)
Fusion with placement of interbody cage and posterolateral instrumentation

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	University of Colorado	Aurora	Colorado
United States	Orthopaedic Associates	Bellaire	Texas
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Boulder Neurosurgical & Spine Associates	Boulder	Colorado
United States	Lahey Clinic	Burlington	Massachusetts
United States	Goodman Campbell Brain & Spine	Carmel	Indiana
United States	Carolina Neurosurgery & Spine Associates, P.A.	Charlotte	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	Univ. of Cincinnati Medical Center	Cincinnati	Ohio
United States	Florida Spine Institute	Clearwater	Florida
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Adventist Health Glendale	Glendale	California
United States	Orthopedic Institute of Pennsylvania	Harrisburg	Pennsylvania
United States	Marshall University	Huntington	West Virginia
United States	St. Vincent's Spine & Brain Institute	Jacksonville	Florida
United States	Bronson Neuroscience Center	Kalamazoo	Michigan
United States	Cedars Sinai	Los Angeles	California
United States	Southern Oregon Orthopedics	Medford	Oregon
United States	Wisconsin Bone and Joint S.C.	Milwaukee	Wisconsin
United States	Physicians Regional Medical Center	Naples	Florida
United States	Lenox Hill Hospital	New York	New York
United States	University of California - Irvine Medical Center	Orange	California
United States	Eisenhower Desert Orthopedic Center	Palm Desert	California
United States	UPENN Health Systems Department of Neurosurgery	Philadelphia	Pennsylvania
United States	Allegheny Health Network	Pittsburgh	Pennsylvania
United States	Texas Back Institute	Plano	Texas
United States	Neurosurgical Associates, P.C.	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	St. Mary's Medical Center, Spine Center	San Francisco	California
United States	Kennedy White Orthopedic Center	Sarasota	Florida
United States	Memorial Health University Medical Center	Savannah	Georgia
United States	Baylor Scott & White	Temple	Texas
United States	Carle Foundation Hospital	Urbana	Illinois
United States	Georgetown University Hospital	Washington	District of Columbia
United States	Sibley Hospital/Johns Hopkins	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Premia Spine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Oswestry Disability Index (ODI)		24 months
Primary	Maintenance or improvement in Neurological status as assessed by a standard neurological exam performed by Investigator		24 months
Primary	No epidural steroid injection, facet joint injection, nerve block, or placement of spinal cord stimulator		24 months
Primary	No subsequent surgical intervention		24 months
Primary	Radiographic confirmation of fusion in control arm and non-fusion in the TOPS arm		24 months
Primary	Absence of any major device related adverse event		24 months
Secondary	Greater range-of-motion through flexion-extension		24 months
Secondary	Improvement (20 mm) in visual analogue scale (VAS) for back pain and worst leg		24 months
Secondary	Reduction in physical component score on SF-12		24 months