Clinical Papers

October 3, 2017

Case Report: Treatment of A 55 Year Old Female With Lateral Epicondylitis

A 55-year-old female with persistent symptoms for 3 years had undergone extensive conservative treatment that included activity modification, NSAIDs, elbow straps, and 3 to 4 steroid injections.Patient was consented to performing ultrasound guided percutaneous tenotomy using the TenJet® device instead of open or arthroscopic surgery. After identifying the defect on ultrasound, the procedure was performed for 4 minutes at setting 8 on the HydroCision® HydroSurgery console.

October 3, 2017

Case Report: Treatment of A 46 Year Old Male With Lateral Epicondylitis

A 46-year-old, athletically active male had persistent symptoms for over 6 months. He had tried physical therapy, received one steroid injection, and was taking NSAIDs for pain management.The patient was eager to have this resolved and opted to undergo a percutaneous tenotomy using the TenJet device instead of open or arthroscopic procedure. Under ultrasound guidance, TenJet device was run for 3 minutes at setting 8 on the HydroCision HydroSurgery console.

September 15, 2017

Case Report: Right Plantar Fasciitis

A 42-year-old female was initially seen in the office in October 2016. At that time, she was complaining of pain underneath the right foot that began 1-1/2 years prior. She was training for a 5K race and noticed the pain after changing her running shoes. The pain was described as sharp and shooting pain that worsened when she was climbing stairs. The pain was greatest upon returning to activity after periods of inactivity. She had treated this with stretching, anti-inflammatory medications and rest. The pain had not resolved. Her pain was rated as 4 out of 10 at rest, but this increased with activity.

September 15, 2017

Case Report: Right Lateral Epicondylitis

A 57-year-old female first presented in January 2017 complaining of right elbow pain. She had been experiencing pain for over a year. She had tried anti-inflammatory medications, two coticosteroid shots, and over 20 physical therapy sessions. She was told by her physical therapist she had “tennis elbow.” She met with an orthopedic surgeon who discussed the idea of open repair, but she was not too keen about the long recovery time that would be needed. Her pain increased with any weight lifting activities she performed, especially those that caused flexion or extension of her elbow. She complained of pain with doing pushups and dips. One of her biggest concerns was her inability to lift and play with her grandchildren as much as she enjoyed.

September 8, 2017

Economic Analysis of Hydrosurgical Decrompression In MicroDisectomy

An economic model has been developed to assess the impact of the SpineJet Hydrosurgery System on the utilization of medical resources. Clinical data, peer reviewed journal articles, and expert opinion were used to formulate the model. Analysis shows that the cost of the SpineJet MicroResector device ($1,125 per procedure) is more than offset by the cost savings afforded by its use. Using data from the Hardenbrook and White cohort study, a net benefit of $2,114 per patient was achieved. Additional economic benefit may be achieved when longer-term savings are considered.

August 23, 2017

Case Report: Right Achilles Calcific Tendinosis

A 60 year old male patient presented with worsening right Achilles pain for 9 months, with no particular inciting event. The pain was at the posterior calcaneus, was constant, with or without weight bearing, but worse with standing and walking. He had four weeks of physical therapy with stretching program, shoe inserts, and had continued to worsen.

June 7, 2017

Examining Safety Profile of TenJet

Our aim was to establish that using focused water jet technology for debridement and aspiration of degenerative tissue associated with chronic tendinopathy is tissue discriminating and has minimal effect on healthy tendon. The reported incidence of tendinopathy in the general population ranges from 1-4% with signi cantly higher rates associated with overuse in athletes and workers, leading to prolonged chronic pain, loss of work days, and disability.Conservative methods for treating the pain associated with chronic tendinosis are in fact limited, and consist of relative rest, disuse, physical therapy for strengthening the tendon, injections of either corticosteroids or platelet rich plasma, (or) another type of percutaneous procedure that utilizes ultrasonic energy. Our aim was to examine the effect of various settings of TenJet, a focused hydrojet technology, on healthy tendon

May 15, 2017

Case Report: Painful Right Shoulder

A 63 year old female was seen concurrently with an orthopedic surgeon for evaluation of persistent right shoulder pain that had failed conservative treatment. She complained of pain with weight bearing in her right arm, and pain at the 90 degree point of her shoulder arc with active shoulder exion. She had positive impingement signs, pain with empty can supraspinatus test, but no weakness.

July 13, 2016

Percutaneous Lumbar Decompression in the Treatment of Lumbar Spinal Stenosis

Lumbar spinal stenosis with symptomatic neurogenic claudication is a frequently encountered clinical entity which requires endoscopic or open spine surgery once the patients fail to respond to conservative therapies. In this case report we present a novel minimally invasive decompression technique using a fluid jet device (HydroCision Inc, Billerica, MA, USA) for a patient with symptomatic spinal stenosis secondary to ligamentum flavum hypertrophy. To our knowledge this approach has never been de- scribed in the medical literature.

May 8, 2016

Comparison of Percutaneous HydroDiscectomy & Open MicroDiscectomy

HydroDiscectomy is a new technique used for percutaneous spinal discectomy that employs a high-intensity stream of water for herniated disc ablation and tissue aspiration. No previous clinical study has examined the effects of percutaneous hydroDiscectomy. The aim of this study is to evaluate the outcomes of hydroDiscectomy compared to open microdiscectomy regarding pain, function, satisfaction, complications and recurrence rates.

September 11, 2013

Effective Disc Preparation For Lumbar Interbody Fusion Using SpineJet XL Instruments

The biomechanical and biological advantages of lumbar interbody fusion depend on the ability to prepare the disc space for a solid intradiscal fusion. The minimal required amount of nucleus removal and endplate preparation for successful fusion has not been conclusively elucidated. It has been shown that only 60% of the overall endplate is prepared with clearance of only 31% of removable disc material from the contralateral side, using conventional instruments. In the technically challenging transforaminal lumbar interbody fusion (TLIF), recent reports suggests that most surgeons probably overestimate the thoroughness of their disc preparation performed using conventional instrumentation. Incomplete removal of disc material can
result in a challenging environment for bone fusion and may lead to increased rates of pseudoarthrosis.

July 12, 2013

Clinical Outcomes of Percutaneous HydroDiscectomy

This was a multi-center retrospective review published in the January, 2013 edition of the Internet Journal of Spine Surgery. Improvement in back pain and radiculopathy occurred in 94% of patients. The authors concluded that Percutaneous Hydrodiscetomy is a viable treatment option with minimal risk of complications for patients with radiculopathy secondary to subligamentous lumbar herniated nucleus pulposus and can be added to the non-surgical treatment algorithm in select patients.

May 16, 2013

A Clinical Evaluation of Percutaneous HydroDiscectomy

An independent clinical consultant reviewed all of the clinical data obtained from published literature, pending publications, and data not published on file with Hydrocision, for percutaneous hydrodiscectomy. Quality analysis was conducted using 5 levels of evidence, ranging from Level I to III with 3 subcategories in Level II, developed by the US Preventive Services Task Force Conclusion: The safety and effectiveness data for the percutaneous hydrodiscectomy studies are consistent across all data sources. There are no device related complications and success rates ranged from 73%-98.6%. The high success rates combined with the positive safety profile associated with the use of the device are acceptable when weighed against the benefits to the patient. The reported clinical data support the use of the SpineJet Hydrodiscectomy System in the treatment of lumbar herniated nucleous pulposus in this select group of patients.

May 5, 2013

A Percutaneous Technique to Treat Radicular Pain

This accepted abstract was presented by Dr. Fred Gerges from St. Elizabeth’s Pain Center in Boston at the Annual Regional Anesthesia Acute Pain Medicine Meeting on May 2, 2013. The report details the successful outcome of the Hydrodiscectomy procedure on a 43 year old male patient, diagnosed with a contained herniated disc, that had not responded well to conservative therapy.

April 23, 2013

A Novel Approach to Lumbar MicroDiscectomy

The recurrence of lumbar disc herniation and neurofibrosis after microdiscectomy is believed to be dependent on the size of the annulotomy and decreased nerve root manipulation respectfully. A modification of the traditional technique of lumbar microdiscectomy was developed at NMCP using a 4-millimeter cannulated system and fluid jet technology (Microresector, HydroCision; Billerica, MA). The purpose of this study is to compare the outcomes of lumbar microdiscectomy performed at a single institution comparing the traditional technique to the modified cannula technique.

October 5, 2012

Case Report: Decompression of a Large Lumbar Disc Herniation

Research indicates that the success of traditional microdiscectomy is limited in part by the resulting incompetence of the annulus following disc decompression procedures for sciatica1. A variety of percutaneous approaches have been developed to directly address the disc in chronic back and leg pain, avoiding the surgical annulotomy and its attendant potentially damaging consequences. However, currently available percutaneous discectomy tools such as the ArthroCare SpineWand the Stryker Dekompressor are limited in their ability to address large lumbar herniations, with most clinical studies limiting inclusion criteria to patients with herniations of less than 6 mm and or no larger than one-third the sagital diameter of the spinal canal.

The present case illustrates use of a new hydrosurgical method (HydroDiscectomy) for disc decompression in which anatomical reduction of a large defect with successful short- term outcome was achieved.

July 18, 2012

Percutaneous HydroDiscectomy: Preliminary Report

The results of percutaneous lumbar Hydrodiscectomy were assessed in 97 patients using Visual Analog Scale (VAS), Oswestry Disability Index (ODI) and Macnab Criteria. Average follow-up time was 5.93. Authors Conclusions: Hydrodiscectomy is an effective minimally invasive percutaneous technique for disc herniation treatment. It is effective not only for radiculopathy but also for low back pain treatment. The surgical outcomes can be better predicted by herniation size and type than by patient age, gender or workers compensation status.

June 5, 2010

Treatment of Lumbar Disc Herniations With Percutaneous HydroDiscectomy

In this article the authors evaluated percutaneous SpineJet HydroDiscectomy for the treatment of lumbar disc herniation in 69 patients. After 270 days post-operatively, ninety-eight percent of the patients reported excellent or good results. The authors concluded that SpineJet percutaneous HydroDiscectomy does not affect the biomechanical stability of the spine and does not result in serious complications.

April 18, 2010

Comparison of SpineJet XL & Conventional Instrumentation for Disk Space Preparation

Although unilateral transforaminal lumbar interbody fusion (TLIF) is widely used because of its benefits, it does have some technical limitations. Removal of disk material and endplate cartilage is difficult, but essential, for proper fusion in unilateral surgery, leading to debate regarding the surgery’s limitations in removing the disk material on the contralateral side. Therefore, authors have conducted a randomized, comparative cadaver study in order to evaluate the efficiency of the surgery when using conventional instruments in the preparation of the disk space and when using the recently developed high-pressure water jet system, SpineJet XL.

July 10, 2009

Case Report: Lumbar Radicular Symptoms in a Twenty Four Year Old Male

A 24-year-old male in the United States Air Force complains of 5-month history of back pain radiating to the left buttock, leg and great toe. There was no inciting event. He rates his pain at 7/10. The pain is aggravated by lifting, coughing, bending, running and bending forward and relieved only slightly by rest. He is unable to perform his duties on the flight line because of his pain. He has failed to improve despite treatment with physical therapy and medications including prednisone. Epidural steroid injections gave approximately 25% decrease in symptoms for a short duration. The patient wishes for definitive treatment to return to the flight line.contralateral posterior disc space, 88% removal of disc from the available cross-sectional disc area was achieved, versus 45% using conventional instruments (p < 0.00001). There was no significant difference in the effectiveness of hydrosurgical instruments in removing disc material in this area versus the total disc surface.

July 28, 2007

HydroDiscectomy: Preliminary Report on 30 Consecutive Cases

A variety of non-surgical percutaneous approaches to symptomatic contained disc prolapses and herniations have been developed in which a discography approach is used. Hydrosurgical methods for soft tissue cutting, aspiration and removal without external suction have been developed.

May 3, 2007

Treatment of Primary Recurrent & Far Lateral Lumbar Herniated Nucleus Pulposus

MicroDiscectomy is the surgical treatment of lumbar herniated nucleus pulposus (HNP). Indications for surgery include radicular pain unresponsive to non­operative therapy, progressive muscle weakness attributed to an involved nerve root, and cauda equina syndrome. Traditionally, the procedure is performed through a hemi-laminotomy with gentle medial retraction of the affected nerve root, incision of the annulus and manual removal of disc material. This procedure provides 85 to 95% good to excellent outcomes in patients with radicular symptoms caused by lumbar disc herniation in the immediate post-operative period.

April 20, 2007

Economic Analysis of Hydrosurgical Disc Space Prep For Interbody Fusion

An economic model has been developed to assess the impact of the SpineJet Hydrosurgery System on the utilization of medical resources. Clinical and pre-clinical (cadaver model) data, peer reviewed journal articles, and expert opinion were used to formulate the model. Analysis shows that the cost of the SpineJet XL devices ($1010 per procedure) is more than offset by the cost savings afforded by their use. Additional economic benefit is achieved when longer-term savings are considered.

May 24, 2006

Disc Space Preparation For Transforming Interbody Fusion

The difficulty of disc preparation for unilateral TLIF using conventional instruments, which results in clearance of only 31% of removable disc material from the contralateral side1, is often not fully appreciated. Retained disc material can result in a challenging environment for bone fusion4 and may lead to increased rates of pseudoarthrosis. The purpose of this study is to evaluate the effectiveness of new hydrosurgical tools in preparing the disc for unilateral TLIF in a cadaver model.

March 8, 2006

The Impact Of Hydrosurgical Instruments & BMP On Minimally Invasive Lumbar Fusion Outcomes

Minimally invasive interbody techniques have become increasingly applied. The difficulties of adequate disc space preparation using the unilateral posterior approach and the resulting negative impact on the environment for fusion have been well documented. To address these challenges, new devices have been developed to improve disc space preparation and biologic materials have been applied.

October 19, 2005

Tissue Consumption Analysis Using the SpineJet MicroResector in a Cadaveric Study

Read further to learn about how the SpineJet MicroResector demonstrates predictable tissue consumption rates for nucleus removal of a broad range of tissue conditions and ages. In this cadaveric study, two disc specimens were chosen that represented the extremes likely to be encountered clinically for this procedure. One specimen was from a 39-year-old woman; her discs were healthy and well hydrated. The other disc specimens were from a 69-year-old man and were desiccated and somewhat degenerated. It was found that the MicroResector safely accessed a targeted area of the disc. The diminishing rate of consumption is attributed to the evacuation of nucleus in the targeted area.

January 6, 2004

Challenges & Opportunities In Disc Space Preparation For Lumbar Interbody Fusion

Lumbar interbody fusion from a posterior approach affords the advantage of adding interbody fusion to a posterolateral fusion while avoiding the added morbidity of an anterior approach to the spine. Transforaminal lumbar interbody fusion (TLIF) provides anterior column support through a single posterolateral approach to the disc space with minimal neural retraction and disruption of only one facet joint. While the cross-sectional area of bone required to obtain an adequate arthrodesis remains unclear, case series consistently report high fusion rates for TLIF. However, prior studies have demonstrated difficulty in removing sufficient disc material through a unilateral approach. It is believed that a larger area of bony contact between the grafts and the vertebral bodies heightens the chances of successful interbody fusion. However, specific regions of the disc space, such as the contralateral posterior quadrant, remain difficult to access with conventional instruments and techniques.