NCT03012776

A Pivotal Study of the Premia Spine TOPS™ System

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 305 (actual)
• Sponsor: Premia Spine · Industry
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-07-17
• Primary completion: 2022-06-27
• Completion: 2023-06-14
• First posted: 2017-01-06
• Last updated: 2024-06-17

Locations

36 sites across 1 country: United States

Regulatory

• FDA-regulated device study