An injectable nucleus replacement as an adjunct to microdiscectomy:

[ADR seeker]

Abstract

Literature indicates that loss of disc tissue from herniation and/or surgery can accelerate degeneration of the disc. The associated loss of disc height may correspond with recurrent back and/or leg pain. A novel hydrogel has been developed to replace lost nucleus pulposus and potentially restore normal disc biomechanics following herniation and surgery. A single-center, non-randomized, prospective feasibility study was undertaken to investigate the use of NuCore Injectable Nucleus hydrogel (Spine Wave, Inc., Shelton, CT, USA) as a replacement for nuclear tissue lost to herniation and microdiscectomy. Fourteen patients were enrolled at the authors' hospital as the initial site in a worldwide multicenter pilot study. Subjects who were entered into the study suffered from radicular pain due to single-level herniated nucleus pulposus and were non-respondent to conservative therapy. Following a standard microdiscectomy procedure, the hydrogel material was injected into the nuclear void to replace what tissue had been lost to the herniation and surgery. Leg and back pain, function and disability scores were monitored pre- and post-operatively through 2 years. Neurologic and physical evaluations, blood and serum analyses, and radiographic evaluations of disc height and implant stability were also performed. Results showed significant improvement for leg and back pain, as well as function scores. No complications or device related adverse events were observed. MR controls confirmed stable position of the implants with no reherniations. Radiographic measurements indicated better maintenance of disc height compared to literature data on microdiscectomy alone.

The NuCore material appears to protect the disc from early collapse following microdiscectomy; and therefore, may have the potential to slow the degenerative cascade of the spinal segment over time.

[mmglobal]

This technology will be interesting. In the past, they would only trim the extruded disc material with discectomy. This increases the risk of recurrent herniation. Then, they started to evacuate the disc space as well as they could by reaching in through the annular tear. This reduces recurrent herniations, but hastens collapse.

There are several types of annular closure devices that will be an interesting adjunct to discectomy. Hopefully, this will allow them to leave as much nucleus as possible intact, while solving the problem of recurrent herniations (via the original annular tear.)

Nucore appeared about the same time as another injectable disc nucleus did. Dascor is similar, but instead of flowing the polymer into the cavity, Dascor puts the nucleus material into a balloon that remains in the disc space. We have an iSpine member who had Dascor. Unfortunately, after her surgery, the trial was halted and the company closed it's doors. There is noone from the company standing behind the product to help her. Most of her questions will go unanswered.

To my knowledge, nucore is still running strong. I have meetings with a couple of prominent local surgeons later this month. I'll ask about how nucore is going. If I learn anything about them, I'll post here.

ADR Seeker... thanks for the post.

Mark

[jsewell]

That is interesting and hopeful stuff. Thanks for the post
judy

[Maria]

I'm very interested in this as well as stem cell type of therapy. I've had two discectomies w/the latter being percutaneous and I think at the time (1992) it was a fairly new surgery and while others may have been successful mine failed horribly. Not just miserably but horribly. I heard from someone that wasn't supposed to tell me that too much disc material was removed as visulization and measuring of amt. of disc back then was in it's "baby stages." Anyone who has been part of the leaning curve on the negative side knows this isn't ideal to say the very least. Maybe something like this would have been very helpfu to me.

All I know is personally in my heart of hearts I hope there are some less traumatic means of dealing with disc bulges and leaking at least perhaps in the beginning. Maybe even saving them from further problems so quickly down the road.. I never wanted a fusion and I'm now far too late for the ADR possibilty altho at one time I was a candidate for 2-3 levels but after 2 discectomies and more pain than I felt I "should have" have had to deal with I am hoping for something on the spinal horizon that isn't quite so traumatic to the spine and maybe nucleus replacement is it.. I have no idea~ just like hearing about it and the actual science and data behind it.

Thank you for keeping us in the loop here. Much appreciated. I do realize each case is individually evaluated and not everyone is a candidate for "whatever" surgery. Just interested.. that's all.