Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis
Condition: Low Back Pain; Leg Pain; Spondylolisthesis; Lumbar Spinal Stenosis
MeSH terms: Spinal Stenosis; Spondylolisthesis; Low Back Pain; Constriction, Pathologic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this multi-center, randomized, clinical study is to establish the safety and
      effectiveness of the TOPS™ System, used following decompression, in the treatment of lower
      back and leg pain with, or without spinal claudication, that results from moderate or severe
      lumbar spinal stenosis at one vertebral level between L3 and L5.
    

Detailed description: 
      This study is being conducted to evaluate a new surgical implant (TOPS™ System, Impliant).
      The TOPS™ System is an alternative to spinal fusion that is designed to stabilize but not
      fuse the affected vertebral level following decompression surgery to alleviate pain stemming
      from moderate/severe lumbar spinal stenosis while maintaining range of motion.

      When non-surgical treatment is ineffective, decompression (including laminectomy and medial
      facetectomy) and fusion of the spinal segments with moderate/severe lumbar spinal stenosis
      has been used to stabilize the motion segment and to alleviate the patient's clinical
      symptoms. Spinal fusion surgery using metal instrumentation is designed to stop motion at a
      painful, unstable spinal segment by permanently fusing the segment. While fusion may decrease
      pain generated at the treated segment, the procedure also eliminate motion at the implanted
      level and transfers and thus increases loads on the adjacent segments.

      The TOPS System is intended to provide stabilization following decompression in patients with
      disease at one level from L3 to L5. The ideal goal of stabilization is to preserve mobility
      but eliminate abnormal motion and prevent deformity. By using the TOPS System, it may be
      possible to preserve load-bearing dynamics and spinal biomechanics, and thereby maintaining
      motion at the treated segment.

      The TOPS surgical technique, utilizing a standard top loading pedicle screw-based system, is
      the same as a standard posterior spinal fusion with the exception of the placement of the
      TOPS motion segment. Therefore, the surgeon will be executing the steps of surgical exposure,
      decompression, insertion of pedicle screws (with attention to proper placement/alignment) and
      closure in the same manner as he/she would in a standard posterior spinal fusion.

      The objective of the clinical investigation is to compare the safety and effectiveness of the
      TOPS System to a control group of patients undergoing posterior spinal fusion with pedicle
      screws and local autograft bone in the treatment of back and leg pain that results from
      moderate/severe lumbar spinal stenosis at a single vertebral level between L3 to L5.

      Prior to entering the study, patients will be evaluated by the investigator according to the
      inclusion/exclusion criteria. Patients recruited to the study will be randomized in a 1:1
      ratio to undergo implantation of the TOPS System or the control spinal fusion procedure.
      Patient follow-up will be evaluated immediately post-operatively and at discharge, 6 weeks, 3
      months, 6 months, 12 months, and 24 months.
    

Intervention name(s): "TOPS System" - Total Posterior Arthroplasty Implant
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Medical Device; Spine; Lumbar Spinal Stenosis; Degenerative Spondylolisthesis; Facet Arthrosis; Back and Leg Pain; Spine Research; Medical Device Research; Impliant; Lumbar Treatment; Spinal Treatment; Spinal Device