273 - NuCoreR Injectable Nucleus replacement for Herniated Lumbar Disc: A Mu...

#273 NuCoreR Injectable Nucleus replacement for Herniated Lumbar Disc: A Multicenter Prospective Clinical Trial with up to 3 Years Follow-up

Lumbar Therapies and Outcomes

Poster Presented by: U. Berlemann

Author(s):

U. Berlemann (1)
for the NuCoreR Nucleus Investigators

(1) Spine Center Thun, Thun, Switzerland

Abstract

We report the data in a single arm prospective study performed at 8 international study centers. A total of 47 (27 male, 20 female) patients with a mean age of 35 (18-57) were enrolled. The protocol was similar at all centers except with regard to required follow-up duration: In the US and Australia follow-up period was 5 years, 3 years in Halle Germany and Thun Switzerland, 2 years in Berlin and Gorlitz Germany and 1 year in Aarau Switzerland.

The NuCoreRmaterial when mixed with a cross linking agent is injected in a liquid form that then cures in situ to a hydrogel, with an intial setting in 5 minutes and a complete cure within 30 minutes.

A statndard microdiscectomy was performed and NuCore material was injected in an amount sufficient to replace the amount of tissue removed. After 5 minutes of curing, the site was closed in standard fashion.

Follow-up at all centers occurred at 6 wks 3, 6 and 12 months at all sites and additionally at 2, 3, 4, and 5 years at some sites depending on protocol. This report contains data up to 3 years post implant. Leg and back pain were assessed using the 0-10 Visual Analog Scale (VAS), function using the Oswestry Disability Index (ODI), and health related quality of life (QoL) using the SF-36. Standing lateral x-rays, MRIs, a neurological examination, adverse event information and changes in medication status were collected at all follow-up visits..

The back pain VAS improved significantly (p< 0.05) from a baseline of 4.1±2.8 (n=47)

to 1.6±1 (n=47), 1.7±1.9( n=42), and 1.4±1.3 ( n=27) at 1, 2, and 3 years respectively. Leg pain at the symptomatic side showed similar signficant sustained decreases. The ODI, at baseline was 45+18 (n=47), with a sustained significant drop (p< 0.05),at 1 (n=47),2 (n=43) and 3 (n=27) years (13±13, 12±13, and 13±13). The average of all componenets of the SF -36 showed a signifcant rise from a pre op score of 46±15, to 81 ±16 at 3 years. There were no abnormal findings at any of the neuorlogical examinations. Disc height data revealed a decrease over the 3 year period beginning with an average disc height of 8.5mm at post-op then slowly decreasing to 7.7. 7.3 and 6.6mm at each annual visit.

Reherniations occurred 12 times in 11 subjects, 9 of which underwent reoperation. All reherniations are considered resolved. There was a total of 78 recorded adverse events in the study, 11 were the symptomatic reherniations. Of the 67 remaining AEs 61 were judged to be not device related according to the examining surgeon. The remaining 6 were leg pain complaints.

In conclusion, this initial multi center study of the NuCoreRInjectable Nucleus demonstrated clinical benefit, a safety profile consistent with current surgical practice and good maintenance of disc height over 3 years.