Research

The Axis Spine Center team leads the way throughout the Inland Northwest in the research and creation of innovative surgical techniques, pain medicines, and therapies. Our research department conducts clinical studies of new procedures and devices, providing patients with access to the latest surgical technologies and furthering the development of non-invasive healing procedures and solutions.

Research Department

  • Shelley Reed, RN, BA, Clinical Research Manager
  • Emmeline Horner, CRC

Studies Currently Enrolling

Study:  Total Posterior Spine System (TOPS)

Condition:  Degenerative Spine Disease:  must include all three of the following: 

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

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.

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.

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.

Status:  Enrolling

Study:  Superion® IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)

Condition:  Lumbar Spinal Stenosis (LSS); intended to treat patients suffering from pain, numbness, and/or cramping in the legs secondary to a diagnosis of moderate degenerative lumbar spinal stenosis. 

Brief Summary:

To compile real-work outcomes of the Superion® indirect decompression system (IDS) in routine clinical practice.  The Superion® IDS is an interspinous spacer that offers an alternative option in the treatment of symptomatic moderate LSS.  It is an FDA approved non-fusion, spinal column load-sharing, device used to stabilize the spine at the implanted level. When implanted between contiguous spinous processes, it is designed to restrict or limit extension at the affected spinal level and so reduce compression of neural elements in extension.

Status:  Enrolling

Active Studies with Closed Enrollment

Study:  Clinical Trial to Compare HF10 Therapy to Conventional Medical Management in the Treatment of Non-Surgical Refractory Back Pain (NSRBP)

Condition:  Non-surgical Refractory Back Pain

Brief Summary:

This study is being conducted to document the safety, clinical effectiveness and cost-effectiveness of high-frequency Spinal Cord Stimulator at 10 kHz (HF10™ Therapy) delivered through the Senza system in subjects with chronic refractory back pain (with or without leg pain) who are not considered candidates for spine surgery.

This study is a multi-center, prospective, randomized study to compare the two treatment groups:

  • Conventional Medical Management (CMM)
  • CMM with the addition of the Spinal Cord Stimulator (HF10 therapy)

Status:  Active; however, closed to enrollment

Study:  Clinical Trial to Validate a Patient User Interface of the Senza Spinal Cord Stimulation (SCS) System in the Treatment of Chronic Back and/or Leg Pain (PUI)

Condition:  Chronic Back and/or Leg Pain

Brief Summary: 

The purpose of this study is to validate a patient user interface (a personal i-pad) to deliver HF10 therapy through the Senza system to the spinal cord in subjects with chronic back and/or leg pain.

Status:  Active; however, closed to enrollment

Study:  Patient Retrospective Outcomes (PRO)

Condition:  Chronic Pain

Brief Summary:

The primary objective of this study is to characterize real-world clinical outcomes with the use of various treatment approaches (e.g. Spinal Cord Stimulation (SCS), Radio Frequency (RF) procedure, Indirect Decompression System (IDS), etc.) for treatment of chronic pain.  This study will evaluate de-identified (anonymous) data to review the clinical outcomes of various chronic pain treatment approaches.  This study is a retrospective, multi-center, de-identified data review.

Status:  Active; enrollment not applicable

Study:  Postmarket Registry for Evaluation of the Superion® Spacer (PRESS)

Condition:  Lumbar Spinal Stenosis

Brief Summary:

To gather evidence documenting the performance and clinical outcomes associated with treatment of moderate degenerative lumbar spinal stenosis using the Superion® IDS in patients ≥45 years of age suffering from symptoms of neurogenic intermittent claudication secondary to a confirmed diagnosis of moderate degenerative lumbar spinal stenosis at one or two contiguous levels from L1 to L5.

Status:  Active; however, closed to enrollment

NEW UPCOMING STUDIES

  • Spinal Cord Stimulator
  • Indirect Decompression Device Study

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