What is Nucleoplasty®?
Nucleoplasty is a procedure name used to describe a disc decompression procedure performed using Coblation® technology to remove tissue in the nucleus pulposus of the disc. Nucleoplasty utilizes a minimally invasive approach to remove disc material and decompress the disc. This is accomplished via a multifunctional bipolar radio frequency device that utilizes Coblation technology to ablate, or remove tissue. Because tissue removal is achieved at temperatures of approximately 40-70ºC, thermal damage to surrounding tissue is minimized. Coblation technology has been used in over 4.5 million procedures to date.
Are the products and technology used in this procedure FDA approved?
Yes. The SpineWandsTM, including the Perc DLR, Perc DLG, and Perc DC have specific FDA 510(k) clearance for “ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.” The products are also CE Marked.
What are the key elements of the procedure?
Nucleoplasty is performed on an outpatient basis, with minimal anesthesia requirements. Fluoroscopic guidance is employed as an introducer needle is placed at the nucleus/annulus junction. A SpineWand is introduced through the passage way, and advanced into the disc nucleus. Using Coblation, tissue is then removed by either creating channels (lumbar spine) or spheres (cervical spine). After sufficient tissue is removed, both the device and introducer needle are removed, a bandage is placed on the skin and the patient is discharged home. Patients are then usually placed on a routine rehabilitation program as part of a standard protocol for interventional spine procedures.
Do you need to aspirate the by-products from ablation?
No. The low molecular weight gases produced by ablation pass out of the disc via the introducer needle. Cadaver and animal studies, along with anecdotal experience, and Percutaneous Lumbar Disc Decompression (PLDD) clinical experience, confirm that aspiration is unnecessary.
Can you do the procedure immediately after a discogram?
Yes. The 17 gauge Crawford needle can be used for access (when performing the discogram), and the needle can remain in place in the annulus for the Nucleoplasty procedure. For improved imaging of the DLR Wand, physicians have suggested a 50% dilution of the contrast used during the discogram.
In the past both Ablation and Coagulation mode were utilized, why does ArthroCare now recommend usage of Ablation mode only?
ArthroCare made this recommendation a number of years ago. Nucleoplasty has two effects, the removal of tissue (i.e. decompression) and also positive biochemical changes. Both of these effects occur during the Ablation mode. Based on this information, ArthroCare’s scientific advisory board no longer recommends the use of coagulation mode for the Nucleoplasty procedure as it not necessary for clinical effect. Not adding any additional heat (as used in the coagulation mode) may also increase the safety of the procedure and potentially reduce the risk of complication.
Can more than six channels be created?
Some practitioners have used more than six channels, or used a bilateral approach creating up to twelve channels in total. Therefore, the clinician should determine the amount of tissue to be removed based upon the patient’s symptoms and anatomy.
Should a physician inject antibiotics after Nucleoplasty?
Use of antibiotics is not required. However, many physicians will administer antibiotics anytime the annulus is penetrated – due to the increased risk of infection leading to discitis (inflammation of the disc). They generally use the same dose as following a discogram.
Does a Nucleoplasty patient need to wear a brace after the procedure?
A brace is not required, since the annulus has not been compromised by the procedure. However, a number of Nucleoplasty centers are using a soft brace for two reasons:
- The brace reminds the patient that they have had a minimally invasive procedure, and they should allow their back to heal (as they progressively return to normal activities).
- The brace requires the patient to maintain good posture for their lower spine – as part of an overall program of post-procedure rehabilitation (to teach the patient good habits for spine posture and conditioning). A Rehabilitation protocol is intended to support an optimal outcome from the Nucleoplasty procedure, while helping the patient to avoid re-injury.
Is a Rehabilitation Protocol recommended following the procedure?
A rehabilitation protocol is recommended, but not necessarily required. Most centers have utilized the same rehabilitation guidelines as they utilize for other interventional spine procedures: bed rest for several days, progressive use of stretching and strengthening exercises, followed by staged return to more normal activities.
What research is currently underway?
Extensive studies have been completed to document the affects of the procedure. Basic science research includes studies of the biochemistry, histology (acute and chronic), temperature, and pressure relative to the Coblation assisted decompression. Clinically, multiple centers around the world, both in University and private practice settings are conducting clinical trials. There are independent studies taking place in the United States, Europe, South America, and the Far East. A number of these studies, both basic science and clinical, have been accepted for presentation at various clinical meetings. A number of multi-center randomized controlled trials are currently underway comparing Nucleoplasty to a variety of other treatment options.
