Nubac from Pioneer Surgical in Netherlands

**Katie** · 12-23-2009, 09:39 PM

Perhaps I have missed this in an earlier post somewhere, but I wanted to know if anyone has heard of this device?

It is a nucleus substitute, and is designed to go inside the natural annulus somehow, restoring height and movement. A surgeon in Germany forwarded the contact information to me, in the hopes that it may work with my allergies. Here is the company's website. Pioneer Surgical Technology Be sure to go to the specific Nubac link on the second page.

Unfortunately it isn't available in either the US or Canada, but I am going to contact them tomorrow and see which surgeons worldwide use it.

It sounds relatively easy, and I hope there is something good to be said about it.

**Justin** · 12-23-2009, 09:47 PM

Nubac® disc arthroplasty: design rationale and clinical evaluation

The Internet Journal of Minimally Invasive Spinal Technology
2008 Supplement I - to IJMIST Vol 1 No 2
A. Giltaij, Copyright Internet Scientific Publications, LLC., 1996 to 2009.

Introduction: Disc arthroplasty is gaining popularity for treatment of low-back pain caused by degenerative disc disease (DDD). As total disc arthroplasty is a relative aggressive treatment with high revision risk efforts have been put into the development of less invasive methods resulting in the development of the NUBAC disc arthroplasty system. This abstract describes the design rationale and the preliminary clinical results obtained for the NUBAC.

Methods: The NUBAC is designed to mimic the natural kinematics of an intact disc and to restore or maintain the load sharing capabilities of the index disc by preserving most of the annulus, ligaments and endplates. Implant insertion is compatible to any surgical approach and minimally invasive. The design rationale of the NUBAC has been demonstrated in as series of human cadaver studies as part of its preclinical evaluation. Aspects investigated were restoration of disc height, maintenance of segmental motion and stability, endplate fatigue strength and static-load-to-failure. A prospective multicenter study with 131 patients investigated pain and function parameters.

Results: Cadaver studies have shown that the device can restore the disc height and segmental mobility and stability to the intact state. No visible endplate or cancellous bone fractures were evident after 100,000 cycles of fatigue testing. Static-load-to-failure has shown that the failure load of the surgical repaired specimen does not decrease. The NUBAC has been implanted in the lumbar spine of 131 patients at 135 levels from L2-S1 with more than 90% at L4/5 and L5/S1 via all three major surgical approaches; posterior, lateral and antero-lateral. Pain relief was investigated by VAS and showed good pain relief from six weeks through 2 years (VAS 78 at baseline to 30, 30, 26, 26 and 23 at 6 weeks, 3, 6 months and 1 and 2 years, respectively). Function using the ODI showed continuous improvement at all visits (53 at baseline to 31, 26, 23, 23 and 10 at 6 weeks, 3, 6 months and 1 and 2 years, respectively).

Conclusions: Preclinical studies show that NUBAC is able to restore disc height, maintains segment mobility and stability. Clinically the pain relief and improvement of function suggest that the NUBAC is a feasible, less invasive alternative for treatment of low back pain caused by DDD.

**Justin** · 12-23-2009, 09:50 PM

Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty

This study is currently recruiting participants.
Verified by Pioneer Surgical Technology, Inc., November 2009

Link: Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty (Clinical Trials Website)

**Justin** · 12-23-2009, 10:02 PM

Cir Cir. 2008 Jul-Aug;76(4):317-21.

Clinical and radiological follow-up of Nubac disc prosthesis. Preliminary report

[Article in Spanish]

Alpízar-Aguirre A, Mireles-Cano JN, Rosales-Olivares M, Miramontes-Martínez V, Reyes-Sánchez A. Servicio de Cirugía de Columna Vertebral, Instituto Nacional de Rehabilitación, Secretaría de Salud, México, D.F.

BACKGROUND: Lumbar arthroplasty is an alternative to fusion for the treatment of degenerative disc disease. Replacement of the nucleus pulposus preserves the biomechanical properties in the annulus and plates, conserving lumbar motion. Our objective was to evaluate the feasibility and clinical and radiological findings at 3 months follow-up with the Nubac device.

METHODS: Ten patients from the National Institute for Rehabilitation (INR, Mexico City) with degenerative disc disease were selected to participate in the study. They underwent discectomy with Nubac device with a follow-up period of 3 months. Evolution was evaluated with the VAS and Oswestry scales.

RESULTS: Five men and five women were included in the study (average age 41.6 years). Surgical approach was anterolateral (4 patients), posterior (3 patients) and anterior (3 patients), VAS improved from 8.1 to 2.5 (p <0.05) and Oswestry Disability Index (ODI) improved from 58.2% to 24.2% (p <0.05). Disc height before surgery was 9.4 mm, and 3 months postoperatively was 12.5 mm with no complications, migration, or subsidence.

CONCLUSIONS: Nubac prosthesis improved lumbar discogenic pain in a short time when evaluated using ODI and VAS scales. Disc height improved after a 3-month follow-up, but lumbar motion did not improve. No complications have been reported; however, a minimum follow-up of 4 years is needed to make a definite conclusion.

**Katie** · 12-23-2009, 10:16 PM

Thanks Justin. I thought I had missed something. The problem with trials is that they only are open to single level candidates. My multi-level lumbar is killing me in more ways than one

I might be able to get by with a single level in my cerivical, but not the lumbar. And is the Nubac only for the lumbar? That's what I am getting from the website, but I may not be reading it correctly.

Thanks again.

**Justin** · 12-23-2009, 10:30 PM

Originally Posted by Katie

Thanks Justin. I thought I had missed something. The problem with trials is that they only are open to single level candidates. My multi-level lumbar is killing me in more ways than one

I know, it's unfortunate that your case is multilevel.

I posted the Clinical Trial link to hopefully give you some more information about the device.

Originally Posted by Katie

I might be able to get by with a single level in my cerivical, but not the lumbar. And is the Nubac only for the lumbar? That's what I am getting from the website, but I may not be reading it correctly.

Thanks again.

I believe it is only for the lumbar spine (all the data I have seen is for lumbar cases).

**Lynda** · 12-24-2009, 06:29 AM

Hi Katie

I'm sorry these PEEK devices aren't available in Canada or the US.

Originally Posted by Katie

I might be able to get by with a single level in my cerivical, but not the lumbar. And is the Nubac only for the lumbar? That's what I am getting from the website, but I may not be reading it correctly.

Nubac is lumbar and Nunec is cervical, have a look the info is on their website.

Best wishes for Christmas and the New Year to All.

Lynda