A Pivotal Study of the Premia Spine TOPS™ System
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|ClinicalTrials.gov Identifier: NCT03012776|
Recruitment Status : Recruiting
First Posted : January 6, 2017
Last Update Posted : November 6, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Lumbar Spinal Stenosis Degenerative Spondylolisthesis||Device: Total Posterior Spine System (TOPS) Procedure: Transforaminal Lumbar Interbody Fusion (TLIF)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||266 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Study to Assess the Safety and Effectiveness of the Premia Spine TOPS™ System|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2023|
Experimental: TOPS System
Investigational surgical treatment using TOPS System
Device: Total Posterior Spine System (TOPS)
Placement of TOPS System to provide posterior stabilization following decompression to treat lumbar spinal stenosis and spondylolisthesis
Active Comparator: Transforaminal Lumbar Interbody Fusion (TLIF)
Control surgical treatment using interbody fusion and placement of posterolateral instrumentation
Procedure: Transforaminal Lumbar Interbody Fusion (TLIF)
Fusion with placement of interbody cage and posterolateral instrumentation
- Improvement in Oswestry Disability Index (ODI) [ Time Frame: 24 months ]
- Maintenance or improvement in Neurological status as assessed by a standard neurological exam performed by Investigator [ Time Frame: 24 months ]
- No epidural steroid injection, facet joint injection, nerve block, or placement of spinal cord stimulator [ Time Frame: 24 months ]
- No subsequent surgical intervention [ Time Frame: 24 months ]
- Radiographic confirmation of fusion in control arm and non-fusion in the TOPS arm [ Time Frame: 24 months ]
- Absence of any major device related adverse event [ Time Frame: 24 months ]
- Greater range-of-motion through flexion-extension [ Time Frame: 24 months ]
- Improvement (20 mm) in visual analogue scale (VAS) for back pain and worst leg [ Time Frame: 24 months ]
- Reduction in physical component score on SF-12 [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03012776
|Contact: Jeff V Withrowemail@example.com|