A Pivotal Study of the Premia Spine TOPS™ System

NCT ID: NCT03012776

Last Updated: 2024-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 305 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-17
• Study Completion Date: 2023-06-14

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.

Conditions

Lumbar Spinal Stenosis; Degenerative Spondylolisthesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TOPS System

Investigational surgical treatment using TOPS System

Group Type: EXPERIMENTAL

Total Posterior Spine System (TOPS)

Intervention Type: DEVICE

Placement of TOPS System to provide posterior stabilization following decompression to treat lumbar spinal stenosis and spondylolisthesis

Transforaminal Lumbar Interbody Fusion (TLIF)

Control surgical treatment using interbody fusion and placement of posterolateral instrumentation

Group Type: ACTIVE_COMPARATOR

Transforaminal Lumbar Interbody Fusion (TLIF)

Intervention Type: PROCEDURE

Fusion with placement of interbody cage and posterolateral instrumentation

Interventions

Total Posterior Spine System (TOPS)

Placement of TOPS System to provide posterior stabilization following decompression to treat lumbar spinal stenosis and spondylolisthesis

Intervention Type: DEVICE

Transforaminal Lumbar Interbody Fusion (TLIF)

Fusion with placement of interbody cage and posterolateral instrumentation

Intervention Type: PROCEDURE

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;

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Premia Spine

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Adventist Health Glendale

Glendale, California, United States

Cedars Sinai

Los Angeles, California, United States

University of California - Irvine Medical Center

Orange, California, United States

Eisenhower Desert Orthopedic Center

Palm Desert, California, United States

St. Mary's Medical Center, Spine Center

San Francisco, California, United States

University of Colorado

Aurora, Colorado, United States

Boulder Neurosurgical & Spine Associates

Boulder, Colorado, United States

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Sibley Hospital/Johns Hopkins

Washington D.C., District of Columbia, United States

Florida Spine Institute

Clearwater, Florida, United States

St. Vincent's Spine & Brain Institute

Jacksonville, Florida, United States

Physicians Regional Medical Center

Naples, Florida, United States

Kennedy White Orthopedic Center

Sarasota, Florida, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Carle Foundation Hospital

Urbana, Illinois, United States

Goodman Campbell Brain & Spine

Carmel, Indiana, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Lahey Clinic

Burlington, Massachusetts, United States

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Bronson Neuroscience Center

Kalamazoo, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Lenox Hill Hospital

New York, New York, United States

Carolina Neurosurgery & Spine Associates, P.A.

Charlotte, North Carolina, United States

Univ. of Cincinnati Medical Center

Cincinnati, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Southern Oregon Orthopedics

Medford, Oregon, United States

Orthopedic Institute of Pennsylvania

Harrisburg, Pennsylvania, United States

UPENN Health Systems Department of Neurosurgery

Philadelphia, Pennsylvania, United States

Allegheny Health Network

Pittsburgh, Pennsylvania, United States

Orthopaedic Associates

Bellaire, Texas, United States

Texas Back Institute

Plano, Texas, United States

Baylor Scott & White

Temple, Texas, United States

Neurosurgical Associates, P.C.

Richmond, Virginia, United States

Marshall University

Huntington, West Virginia, United States

Wisconsin Bone and Joint S.C.

Milwaukee, Wisconsin, United States

Countries

United States

References

Coric D, Nassr A, Kim PK, Welch WC, Robbins S, DeLuca S, Whiting D, Chahlavi A, Pirris SM, Groff MW, Chi JH, Huang JH, Kent R, Whitmore RG, Meyer SA, Arnold PM, Patel AI, Orr RD, Krishnaney A, Boltes P, Anekstein Y, Steinmetz MP. Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis. J Neurosurg Spine. 2022 Sep 23;38(1):115-125. doi: 10.3171/2022.7.SPINE22536. Print 2023 Jan 1.

Reference Type: DERIVED

PMID: 36152329 (View on PubMed)

Other Identifiers

CL-2830 - US IDE

Identifier Type: -

Identifier Source: org_study_id